Effect of post-operative goal-directed fluid therapy (GDFT) on organ function after orthotopic liver transplantation: Secondary outcome analysis of the COLT randomised control trial.

BACKGROUND: Goal-directed fluid therapy (GDFT) has been shown to reduce the complications following a variety of major surgical procedures, possibly mediated by improved organ perfusion and function. We have shown that it is feasible to randomise patients to GDFT or standard fluid management following liver transplant in the cardiac-output optimisation following liver transplantation (COLT) trial. The current study compares end organ function in patients from the COLT trial who received GDFT in comparison to those receiving standard care (SC) following liver transplant. METHODS: Adult patients with liver cirrhosis undergoing liver transplantation were randomised to GDFT or SC for the first 12 h following surgery as detailed in a published trial protocol. GDFT protocol was based on stroke volume (SV) optimisation using 250 ml crystalloid boluses. Total fluid administration and time to extubation were recorded. Hourly SV and cardiac output (CO) readings were recorded from the non-invasive cardiac output monitoring (NICOM) device in both groups. Pulmonary function was assessed by arterial blood gas (ABG) and ventilatory parameters. Lung injury was assessed using PaO2:FiO2 ratios and calculated pulmonary compliance. The KDIGO score was used for determining acute kidney injury. Renal and liver graft function were assessed during the post-operative period and at 3 months and 1-year. RESULTS: 60 patients were randomised to GDFT (n = 30) or SC (n = 30). All patients completed the 12 h intervention period. GDFT group received a significantly higher total volume of fluid during the 12 h trial intervention period (GDFT 5317 (2335) vs. SC 3807 (1345) ml, p = 0.003); in particular crystalloids (GDFT 3968 (2073) vs. SC 2510 (1027) ml, p = 0.002). There was no evidence of significant difference between the groups in SV or CO during the assessment periods. Time to extubation, PaO2: FIO2 ratios, pulmonary compliance, ventilatory or blood gas measurements were similar in both groups. There was a significant rise in serum creatinine from baseline (77 µmol/L) compared to first (87 µmol/L, p = 0.039) and second (107 µmol/L, p = 0.001) post-operative days. There was no difference between GDFT and SC in the highest KDIGO scores for the first 7 days post-LT. At 1-year follow-up, there was no difference in need for renal replacement therapy or graft function. CONCLUSIONS: In this randomised trial of fluid therapy post liver transplant, GDFT was associated with an increased volume of crystalloids administered but did not alter early post-operative pulmonary or renal function when compared with standard care.

The cardiac output optimisation following liver transplant (COLT) trial: a feasibility randomised controlled trial.

BACKGROUND: Perioperative goal directed fluid therapy (GDFT) has been shown to reduce postoperative complications following major surgery; this intervention has not been formally evaluated in the setting of liver transplantation. METHODS: We conducted a prospective trial of GDFT following liver transplantation randomising patients with liver cirrhosis to either 12 h of GDFT using non-invasive cardiac output monitoring or standard care (SC). The primary outcome was feasibility. Secondary outcomes included survival, postoperative complications (Clavien-Dindo), quality of life (by EQ-5D-5L) and resource use. Trial specific follow up occurred at 90 and 180 days after surgery. RESULTS: The study was feasible. Of 224 eligible patients, 122 were approached, 114 consented to participate and 60 were enrolled into the trial. The mean (SD) volume of IV crystalloid administered to the GDFT group during the 12-h study period was 3968 (2073) ml for the GDFT group and 2510 (1026) ml for the SC group. As regards secondary outcomes there was no difference in survival or overall complication rates. There was no significant difference in quality of life scores and resource use between the groups. CONCLUSION: A randomised study of GDFT following liver transplantation is feasible. A post-trial stakeholder meeting supported proceeding with a full multi-centre trial.

Cardiac output Optimisation following Liver Transplant (COLT) trial: study protocol for a feasibility randomised controlled trial.

BACKGROUND: Patients with liver cirrhosis undergoing liver transplantation have a hyperdynamic circulation which persists into the early postoperative period making accurate assessment of fluid requirements challenging. Goal-directed fluid therapy (GDFT) has been shown to reduce morbidity and mortality in a number of surgery settings. The impact of GDFT in patients undergoing liver transplantation is unknown. A feasibility trial was designed to determine patient and clinician support for recruitment into a randomised controlled trial of GDFT following liver transplantation, adherence to a GDFT protocol, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate the efficacy of GDFT in patients undergoing liver transplantation. METHODS: The Cardiac output Optimisation following Liver Transplant (COLT) trial is designed as a prospective, single-centre, randomised controlled study to assess the feasibility and safety of GDFT in liver transplantation for patients with cirrhosis. Consenting adults (aged between 18 and 80 years) with biopsy-proven liver cirrhosis who have been selected to undergo a first liver transplantation will be included in the trial and randomised into GDFT or standard care starting immediately after surgery and continuing for the first 12 h thereafter. Both groups will have cardiac output and stroke volume monitored using the FloTrac (EV1000) device. The intervention will consist of a protocolised GDFT approach to patient management, using stroke volume optimisation. The control group will receive standard care, without stroke volume and cardiac output measurement. After 12 h the patient's fluid management will revert to standard of care. The primary endpoint of this study is feasibility. Secondary endpoints will include a safety assessment of the intervention, graft and patient survival, liver function, postoperative complications graded by Clavien-Dindo criteria, length of intensive care and hospital stay and quality of life across the intervention and control groups. DISCUSSION: There is a growing body of evidence that the use of perioperative GDFT in surgical patients can improve outcomes; however, signals of harm have also been detected. Patients with liver cirrhosis undergoing liver transplantation have markedly different cardiovascular physiology than general surgical patients. If GDFT is proven to be feasible and safe in this patient group, then a multicentre trial to demonstrate efficacy and cost-effectiveness will be required. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Registry, ID: ISRCTN10329248. Registered on 4 April 2016.

Pharmacological interventions for acute pancreatitis.

BACKGROUND: In people with acute pancreatitis, it is unclear what the role should be for medical treatment as an addition to supportive care such as fluid and electrolyte balance and organ support in people with organ failure. OBJECTIVES: To assess the effects of different pharmacological interventions in people with acute pancreatitis. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, 2016, Issue 9), MEDLINE, Embase, Science Citation Index Expanded, and trial registers to October 2016 to identify randomised controlled trials (RCTs). We also searched the references of included trials to identify further trials. SELECTION CRITERIA: We considered only RCTs performed in people with acute pancreatitis, irrespective of aetiology, severity, presence of infection, language, blinding, or publication status for inclusion in the review. DATA COLLECTION AND ANALYSIS: Two review authors independently identified trials and extracted data. We did not perform a network meta-analysis as planned because of the lack of information on potential effect modifiers and differences of type of participants included in the different comparisons, when information was available. We calculated the odds ratio (OR) with 95% confidence intervals (CIs) for the binary outcomes and rate ratios with 95% CIs for count outcomes using a fixed-effect model and random-effects model. MAIN RESULTS: We included 84 RCTs with 8234 participants in this review. Six trials (N = 658) did not report any of the outcomes of interest for this review. The remaining 78 trials excluded 210 participants after randomisation. Thus, a total of 7366 participants in 78 trials contributed to one or more outcomes for this review. The treatments assessed in these 78 trials included antibiotics, antioxidants, aprotinin, atropine, calcitonin, cimetidine, EDTA (ethylenediaminetetraacetic acid), gabexate, glucagon, iniprol, lexipafant, NSAIDs (non-steroidal anti-inflammatory drugs), octreotide, oxyphenonium, probiotics, activated protein C, somatostatin, somatostatin plus omeprazole, somatostatin plus ulinastatin, thymosin, ulinastatin, and inactive control. Apart from the comparison of antibiotics versus control, which included a large proportion of participants with necrotising pancreatitis, the remaining comparisons had only a small proportion of patients with this condition. Most trials included either only participants with severe acute pancreatitis or included a mixture of participants with mild acute pancreatitis and severe acute pancreatitis (75 trials). Overall, the risk of bias in trials was unclear or high for all but one of the trials. SOURCE OF FUNDING: seven trials were not funded or funded by agencies without vested interest in results. Pharmaceutical companies partially or fully funded 21 trials. The source of funding was not available from the remaining trials.Since we considered short-term mortality as the most important outcome, we presented only these results in detail in the abstract. Sixty-seven studies including 6638 participants reported short-term mortality. There was no evidence of any differences in short-term mortality in any of the comparisons (very low-quality evidence). With regards to other primary outcomes, serious adverse events (number) were lower than control in participants taking lexipafant (rate ratio 0.67, 95% CI 0.46 to 0.96; N = 290; 1 study; very low-quality evidence), octreotide (rate ratio 0.74, 95% CI 0.60 to 0.89; N = 770; 5 studies; very low-quality evidence), somatostatin plus omeprazole (rate ratio 0.36, 95% CI 0.19 to 0.70; N = 140; 1 study; low-quality evidence), and somatostatin plus ulinastatin (rate ratio 0.30, 95% CI 0.15 to 0.60; N = 122; 1 study; low-quality evidence). The proportion of people with organ failure was lower in octreotide than control (OR 0.51, 95% CI 0.27 to 0.97; N = 430; 3 studies; very low-quality evidence). The proportion of people with sepsis was lower in lexipafant than control (OR 0.26, 95% CI 0.08 to 0.83; N = 290; 1 study; very low-quality evidence). There was no evidence of differences in any of the remaining comparisons in these outcomes or for any of the remaining primary outcomes (the proportion of participants experiencing at least one serious adverse event and the occurrence of infected pancreatic necrosis). None of the trials reported heath-related quality of life. AUTHORS' CONCLUSIONS: Very low-quality evidence suggests that none of the pharmacological treatments studied decrease short-term mortality in people with acute pancreatitis. However, the confidence intervals were wide and consistent with an increase or decrease in short-term mortality due to the interventions. We did not find consistent clinical benefits with any intervention. Because of the limitations in the prognostic scoring systems and because damage to organs may occur in acute pancreatitis before they are clinically manifest, future trials should consider including pancreatitis of all severity but power the study to measure the differences in the subgroup of people with severe acute pancreatitis. It may be difficult to power the studies based on mortality. Future trials in participants with acute pancreatitis should consider other outcomes such as complications or health-related quality of life as primary outcomes. Such trials should include health-related quality of life, costs, and return to work as outcomes and should follow patients for at least three months (preferably for at least one year).

Long-term survival with repeated resections of recurrent hepatocellular carcinoma in a non-cirrhotic liver: case report and brief review of the literature.

A healthy and asymptomatic 55-year-old woman underwent a complete (R0) non-anatomical resection of an incidentally detected solitary hepatocellular carcinoma (HCC) in a non-cirrhotic liver. Six years following the initial R0 non-anatomical resection, intrahepatic recurrence was diagnosed and the patient underwent a second R0 non-anatomical resection. At 12.5 years following the initial resection, a further intrahepatic recurrence was diagnosed, which was once again completely resected by left lateral hepatectomy. This represents one of the longest reported periods between initial resection and HCC recurrence, following repeated R0 resections in the absence of cirrhosis. The appropriate surveillance period and genetic testing protocol for such cases remains to be established.

Surgical management of acute cholecystitis.

BACKGROUND: Acute cholecystitis occurs in approximately 1% of patients with known gallstones. It presents as a surgical emergency and usually requires hospitalisation for treatment. It is associated with significant morbidity and mortality, particularly in the elderly. Cholecystectomy is advocated for acute cholecystitis; however, the timing of cholecystectomy and the value of the additional treatments have been a matter of debate. This review examines the available evidence regarding the optimal surgical management of patients with acute cholecystitis. METHODS: A literature search was performed on the MEDLINE, EMBASE and WHO International Clinical Trials Registry Platform, databases for English language publications. The MeSH headings 'cholecystitis', 'acute', 'gallbladder', 'inflammation', 'surgery', 'cholecystectomy', 'laparoscopic', 'robotic', 'telerobotic' and 'computer-assisted' were used. RESULTS: Data from eight randomised controlled trails and three population-based analyses show that early cholecystectomy for acute cholecystitis performed on the index admission is safe and not associated with increased conversion rates or morbidity in comparison to conservative treatment followed by elective cholecystectomy. Delaying cholecystectomy increases readmissions for gallstone-related events, complications, hospital stay and mortality in the elderly. Early cholecystectomy is also more cost-effective. Randomised trials addressing antibiotic use in acute cholecystitis suggest that antibiotics should be stopped on the day of cholecystectomy. Insufficient trials have been performed to address the optimal analgesia regime post cholecystectomy. Similarly, a lack of trials on intraoperative cholangiography and management of common bile duct stones in patients with acute cholecystitis means that treatment of concomitant bile duct stones should be based on institutional expertise and resource availability. As regards acute cholecystitis in elderly and high-risk patients, case series and retrospective studies would suggest that cholecystectomy is more effective and of lower mortality than percutaneous cholecystostomy. There is not enough evidence to support the routine use of robotic surgery, single-incision laparoscopic cholecystectomy or natural orifice transluminal endoscopic surgery (NOTES) in the treatment of acute cholecystitis. CONCLUSIONS: Trial evidence would favour a policy of early laparoscopic cholecystectomy following admission with acute cholecystitis. The optimal approach to support early cholecystectomy is suggested but requires evidence from further randomised trials.

Antibiotic therapy for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) in non surgical wounds.

BACKGROUND: Non surgical wounds include chronic ulcers (pressure or decubitus ulcers, venous ulcers, diabetic ulcers, ischaemic ulcers), burns and traumatic wounds. The prevalence of methicillin-resistant Staphylococcus aureus (MRSA) colonisation (i.e. presence of MRSA in the absence of clinical features of infection such as redness or pus discharge) or infection in chronic ulcers varies between 7% and 30%. MRSA colonisation or infection of non surgical wounds can result in MRSA bacteraemia (infection of the blood) which is associated with a 30-day mortality of about 28% to 38% and a one-year mortality of about 55%. People with non surgical wounds colonised or infected with MRSA may be reservoirs of MRSA, so it is important to treat them, however, we do not know the optimal antibiotic regimen to use in these cases. OBJECTIVES: To compare the benefits (such as decreased mortality and improved quality of life) and harms (such as adverse events related to antibiotic use) of all antibiotic treatments in people with non surgical wounds with established colonisation or infection caused by MRSA. SEARCH METHODS: We searched the following databases: The Cochrane Wounds Group Specialised Register (searched 13 March 2013); The Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2); Database of Abstracts of Reviews of Effects (2013, Issue 2); NHS Economic Evaluation Database (2013, Issue 2); Ovid MEDLINE (1946 to February Week 4 2013); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, March 12, 2013); Ovid EMBASE (1974 to 2013 Week 10); EBSCO CINAHL (1982 to 8 March 2013). SELECTION CRITERIA: We included only randomised controlled trials (RCTs) comparing antibiotic treatment with no antibiotic treatment or with another antibiotic regimen for the treatment of MRSA-infected non surgical wounds. We included all relevant RCTs in the analysis, irrespective of language, publication status, publication year, or sample size. DATA COLLECTION AND ANALYSIS: Two review authors independently identified the trials, and extracted data from the trial reports. We calculated the risk ratio (RR) with 95% confidence intervals (CI) for comparing the binary outcomes between the groups and planned to calculate the mean difference (MD) with 95% CI for comparing the continuous outcomes. We planned to perform the meta-analysis using both fixed-effect and random-effects models. We performed intention-to-treat analysis whenever possible. MAIN RESULTS: We identified three trials that met the inclusion criteria for this review. In these, a total of 47 people with MRSA-positive diabetic foot infections were randomised to six different antibiotic regimens. While these trials included 925 people with multiple pathogens, they reported the information on outcomes for people with MRSA infections separately (MRSA prevalence: 5.1%). The only outcome reported for people with MRSA infection in these trials was the eradication of MRSA. The three trials did not report the review's primary outcomes (death and quality of life) and secondary outcomes (length of hospital stay, use of healthcare resources and time to complete wound healing). Two trials reported serious adverse events in people with infection due to any type of bacteria (i.e. not just MRSA infections), so the proportion of patients with serious adverse events was not available for MRSA-infected wounds. Overall, MRSA was eradicated in 31/47 (66%) of the people included in the three trials, but there were no significant differences in the proportion of people in whom MRSA was eradicated in any of the comparisons, as shown below.1. Daptomycin compared with vancomycin or semisynthetic penicillin: RR of MRSA eradication 1.13; 95% CI 0.56 to 2.25 (14 people).2. Ertapenem compared with piperacillin/tazobactam: RR of MRSA eradication 0.71; 95% CI 0.06 to 9.10 (10 people).3. Moxifloxacin compared with piperacillin/tazobactam followed by amoxycillin/clavulanate: RR of MRSA eradication 0.87; 95% CI 0.56 to 1.36 (23 people). AUTHORS' CONCLUSIONS: We found no trials comparing the use of antibiotics with no antibiotic for treating MRSA-colonised non-surgical wounds and therefore can draw no conclusions for this population. In the trials that compared different antibiotics for treating MRSA-infected non surgical wounds, there was no evidence that any one antibiotic was better than the others. Further well-designed RCTs are necessary.

Abdominal lift for laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy (key-hole removal of the gallbladder) is now the most often used method for treatment of symptomatic gallstones. Several cardiopulmonary changes (decreased cardiac output, pulmonary compliance, and increased peak airway pressure) occur during pneumoperitoneum, which is now introduced to allow laparoscopic cholecystectomy. These cardiopulmonary changes may not be tolerated in individuals with poor cardiopulmonary reserve. OBJECTIVES: To assess the benefits and harms of abdominal wall lift compared to pneumoperitoneum in patients undergoing laparoscopic cholecystectomy. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013. SELECTION CRITERIA: We included all randomised clinical trials comparing abdominal wall lift (with or without pneumoperitoneum) versus pneumoperitoneum. DATA COLLECTION AND ANALYSIS: We calculated the risk ratio (RR), rate ratio (RaR), or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis with both the fixed-effect and the random-effects models using the Review Manager (RevMan) software. MAIN RESULTS: For abdominal wall lift with pneumoperitoneum versus pneumoperitoneum, a total of 130 participants (all with low anaesthetic risk) scheduled for elective laparoscopic cholecystectomy were randomised in five trials to abdominal wall lift with pneumoperitoneum (n = 53) versus pneumoperitoneum only (n = 52). One trial which included 25 people did not state the number of participants in each group. All five trials had a high risk of bias. There was no mortality or conversion to open cholecystectomy in any of the participants in the trials that reported these outcomes. There was no significant difference in the rate of serious adverse events between the two groups (two trials; 2/29 events (0.069 events per person) versus 2/29 events (0.069 events per person); rate ratio 1.00; 95% CI 0.17 to 5.77). None of the trials reported quality of life, the proportion of people discharged as day-patient laparoscopic cholecystectomies, or pain between four and eight hours after the operation. There was no significant difference in the operating time between the two groups (four trials; 53 participants versus 54 participants; 13.39 minutes longer (95% CI 2.73 less to 29.51 minutes longer) in the abdominal wall lift with pneumoperitoneum group and 100 minutes in the pneumoperitoneum group).For abdominal wall lift versus pneumoperitoneum, a total of 774 participants (the majority with low anaesthetic risk) scheduled for elective laparoscopic cholecystectomy were randomised in 18 trials to abdominal wall lift without pneumoperitoneum (n = 332) versus pneumoperitoneum (n = 358). One trial which included 84 people did not state the number in each group. All the trials had a high risk of bias. There was no mortality in any of the trials that reported this outcome. There was no significant difference in the proportion of participants with serious adverse events (six trials; 5/172 (weighted proportion 2.4%) versus 2/171 (1.2%); RR 2.01; 95% CI 0.52 to 7.80). There was no significant difference in the rate of serious adverse events between the two groups (three trials; 5/99 events (weighted number of events per person = 0.346 events) versus 2/99 events (0.020 events per person); rate ratio 1.73; 95% CI 0.35 to 8.61). None of the trials reported quality of life or pain between four and eight hours after the operation. There was no significant difference in the proportion of people who underwent conversion to open cholecystectomy (11 trials; 5/225 (weighted proportion 2.3%) versus 7/235 (3.0%); RR 0.76; 95% CI 0.26 to 2.21). The operating time was significantly longer in the abdominal wall lift group than in the pneumoperitoneum group (16 trials; 6.87 minutes longer (95% CI 4.74 minutes to 9.00 minutes longer) in the abdominal wall lift group versus 75 minutes in the pneumoperitoneum group). There was no significant difference in the proportion of people discharged as laparoscopic cholecystectomy day-patients (two trials; 15/31 (weighted proportion 48.5%) versus 9/31 (29%); RR 1.67; 95% CI 0.85 to 3.26). AUTHORS' CONCLUSIONS: Abdominal wall lift with or without pneumoperitoneum does not seem to offer an advantage over pneumoperitoneum in any of the patient-oriented outcomes for laparoscopic cholecystectomy in people with low anaesthetic risk. Hence it cannot be recommended routinely. The safety of abdominal wall lift is yet to be established. More research on the topic is needed because of the risk of bias in the included trials and because of the risk of type I and type II random errors due to the few participants included in the trials. Future trials should include people at higher anaesthetic risk. Furthermore, such trials should include blinded assessment of outcomes.

Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy is the main method of treatment of symptomatic gallstones. Drains are used after laparoscopic cholecystectomy to prevent abdominal collections. However, drain use may increase infective complications and delay discharge. OBJECTIVES: The aim is to assess the benefits and harms of routine abdominal drainage in uncomplicated laparoscopic cholecystectomy. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013. SELECTION CRITERIA: We included all randomised clinical trials comparing drainage versus no drainage after uncomplicated laparoscopic cholecystectomy irrespective of language and publication status. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures defined by The Cochrane Collaboration. MAIN RESULTS: A total of 1831 participants were randomised to drain (915 participants) versus 'no drain' (916 participants) in 12 trials included in this review. Only two trials including 199 participants were of low risk of bias. Nine trials included patients undergoing elective laparoscopic cholecystectomy exclusively. One trial included patients undergoing laparoscopic cholecystectomy for acute cholecystitis exclusively. One trial included patients undergoing elective and emergency laparoscopic cholecystectomy, and one trial did not provide this information. The average age of participants in the trials ranged between 48 years and 63 years in the 10 trials that provided this information. The proportion of females ranged between 55.0% and 79.0% in the 11 trials that provided this information. There was no significant difference between the drain group (1/840) (adjusted proportion: 0.1%) and the 'no drain' group (2/841) (0.2%) (RR 0.41; 95% CI 0.04 to 4.37) in short-term mortality in the ten trials with 1681 participants reporting on this outcome. There was no significant difference between the drain group (7/567) (adjusted proportion: 1.1%) and the 'no drain' group (3/576) (0.5%) in the proportion of patients who developed serious adverse events in the seven trials with 1143 participants reporting on this outcome (RR 2.12; 95% CI 0.67 to 7.40) or in the number of serious adverse events in each group reported by eight trials with 1286 participants; drain group (12/646) (adjusted rate: 1.5 events per 100 participants) versus 'no drain' group (6/640) (0.9 events per 100 participants); rate ratio 1.60; 95% CI 0.66 to 3.87). There was no significant difference in the quality of life between the two groups (one trial; 93 participants; SMD 0.22; 95% CI -0.19 to 0.63). The proportion of patients who were discharged as day-procedure laparoscopic cholecystectomy seemed significantly lower in the drain group than the 'no drain' group (one trial; 68 participants; drain group (0/33) (adjusted proportion: 0.2%) versus 'no drain' group (11/35) (31.4%); RR 0.05; 95% CI 0.00 to 0.75). There was no significant difference in the length of hospital stay between the two groups (five trials; 449 participants; MD 0.22 days; 95% CI -0.06 days to 0.51 days). The operating time was significantly longer in the drain group than the 'no drain' group (seven trials; 775 participants; MD 5.00 minutes; 95% CI 2.69 minutes to 7.30 minutes). There was no significant difference in the return to normal activity and return to work between the groups in one trial involving 100 participants. This trial did not provide any information from which the standard deviation could be imputed and so the confidence intervals could not be calculated for these outcomes. AUTHORS' CONCLUSIONS: There is currently no evidence to support the routine use of drain after laparoscopic cholecystectomy. Further well designed randomised clinical trials are necessary.

Antibiotic therapy for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in surgical wounds.

BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) infection after surgery is usually rare, but incidence can be up to 33% in certain types of surgery. Postoperative MRSA infection can occur as surgical site infections (SSI), chest infections, or bloodstream infections (bacteraemia). The incidence of MRSA SSIs varies from 1% to 33% depending upon the type of surgery performed and the carrier status of the individuals concerned. The optimal antibiotic regimen for the treatment of MRSA in surgical wounds is not known. OBJECTIVES: To compare the benefits and harms of various antibiotic treatments in people with established surgical site infections (SSIs) caused by MRSA . SEARCH METHODS: In February 2013 we searched the following databases: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Database of Abstracts of Reviews of Effects (DARE); NHS Economic Evaluation Database; Health Technology Assessment (HTA) Database; Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. SELECTION CRITERIA: We included only randomised controlled trials (RCTs) comparing one antibiotic regimen with another antibiotic regimen for the treatment of SSIs due to MRSA. All RCTs irrespective of language, publication status, publication year, or sample size were included in the analysis. DATA COLLECTION AND ANALYSIS: Two review authors independently decided on inclusion and exclusion of trials, and extracted data. We planned to calculate the risk ratio (RR) with 95% confidence intervals (CI) for comparing the binary outcomes between the groups and mean difference (MD) with 95% CI for comparing the continuous outcomes. We planned to perform the meta-analysis using both a fixed-effect and a random-effects model. We performed intention-to-treat analysis whenever possible. MAIN RESULTS: We included one trial involving 59 people hospitalised because of MRSA SSIs. Thirty participants were randomised to linezolid (600 mg either intravenously or orally every 12 hours for seven to 14 days) and 29 to vancomycin (1 g intravenously every 12 hours for seven to 14 days). The type of surgical procedures that were performed were not reported. The trial reported one outcome, which was the eradication of MRSA. The proportion of people in whom MRSA was eradicated was statistically significantly higher in the linezolid group than in the vancomycin group (RR 1.80; 95% CI 1.20 to 2.68). AUTHORS' CONCLUSIONS: There is currently no evidence to recommend any specific antibiotic in the treatment of MRSA SSIs. Linezolid is superior to vancomycin in the eradication of MRSA SSIs on the basis of evidence from one small trial that was at high risk of bias, but the overall clinical implications of using linezolid instead of vancomycin are not known. Further well-designed randomised clinical trials are necessary in this area.

Antibiotic prophylaxis for the prevention of methicillin-resistant Staphylococcus aureus (MRSA) related complications in surgical patients.

BACKGROUND: Risk of methicillin-resistant Staphylococcus aureus (MRSA) infection after surgery is generally low, but affects up to 33% of patients after certain types of surgery. Postoperative MRSA infection can occur as surgical site infections (SSIs), chest infections, or bloodstream infections (bacteraemia). The incidence of MRSA SSIs varies from 1% to 33% depending upon the type of surgery performed and the carrier status of the individuals concerned. The optimal prophylactic antibiotic regimen for the prevention of MRSA after surgery is not known. OBJECTIVES: To compare the benefits and harms of all methods of antibiotic prophylaxis in the prevention of postoperative MRSA infection and related complications in people undergoing surgery. SEARCH METHODS: In March 2013 we searched the following databases: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library); NHS Economic Evaluation Database (The Cochrane Library); Health Technology Assessment (HTA) Database (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. SELECTION CRITERIA: We included only randomised controlled trials (RCTs) that compared one antibiotic regimen used as prophylaxis for SSIs (and other postoperative infections) with another antibiotic regimen or with no antibiotic, and that reported the methicillin resistance status of the cultured organisms. We did not limit our search for RCTs by language, publication status, publication year, or sample size. DATA COLLECTION AND ANALYSIS: Two review authors independently identified the trials for inclusion in the review, and extracted data. We calculated the risk ratio (RR) with 95% confidence intervals (CI) for comparing binary outcomes between the groups and planned to calculated the mean difference (MD) with 95% CI for comparing continuous outcomes. We planned to perform meta-analysis using both a fixed-effect model and a random-effects model. We performed intention-to-treat analysis whenever possible. MAIN RESULTS: We included 12 RCTs, with 4704 participants, in this review. Eleven trials performed a total of 16 head-to-head comparisons of different prophylactic antibiotic regimens. Antibiotic prophylaxis was compared with no antibiotic prophylaxis in one trial. All the trials were at high risk of bias. With the exception of one trial in which all the participants were positive for nasal carriage of MRSA or had had previous MRSA infections, it does not appear that MRSA was tested or eradicated prior to surgery; nor does it appear that there was high prevalence of MRSA carrier status in the people undergoing surgery.There was no sufficient clinical similarity between the trials to perform a meta-analysis. The overall all-cause mortality in four trials that reported mortality was 14/1401 (1.0%) and there were no significant differences in mortality between the intervention and control groups in each of the individual comparisons. There were no antibiotic-related serious adverse events in any of the 561 people randomised to the seven different antibiotic regimens in four trials (three trials that reported mortality and one other trial). None of the trials reported quality of life, total length of hospital stay or the use of healthcare resources. Overall, 221/4032 (5.5%) people developed SSIs due to all organisms, and 46/4704 (1.0%) people developed SSIs due to MRSA.In the 15 comparisons that compared one antibiotic regimen with another, there were no significant differences in the proportion of people who developed SSIs. In the single trial that compared an antibiotic regimen with placebo, the proportion of people who developed SSIs was significantly lower in the group that received antibiotic prophylaxis with co-amoxiclav (or cefotaxime if allergic to penicillin) compared with placebo (all SSI: RR 0.26; 95% CI 0.11 to 0.65; MRSA SSI RR 0.05; 95% CI 0.00 to 0.83). In two trials that reported MRSA infections other than SSI, 19/478 (4.5%) people developed MRSA infections including SSI, chest infection and bacteraemia. There were no significant differences in the proportion of people who developed MRSA infections at any body site in these two comparisons. AUTHORS' CONCLUSIONS: Prophylaxis with co-amoxiclav decreases the proportion of people developing MRSA infections compared with placebo in people without malignant disease undergoing percutaneous endoscopic gastrostomy insertion, although this may be due to decreasing overall infection thereby preventing wounds from becoming secondarily infected with MRSA. There is currently no other evidence to suggest that using a combination of multiple prophylactic antibiotics or administering prophylactic antibiotics for an increased duration is of benefit to people undergoing surgery in terms of reducing MRSA infections. Well designed RCTs assessing the clinical effectiveness of different antibiotic regimens are necessary on this topic.

Early versus delayed laparoscopic cholecystectomy for uncomplicated biliary colic.

BACKGROUND: Uncomplicated biliary colic is one of the commonest indications for laparoscopic cholecystectomy. Laparoscopic cholecystectomy involves several months of waiting if performed electively. However, people can develop life-threatening complications during this waiting period. OBJECTIVES: To assess the benefits and harms of early versus delayed laparoscopic cholecystectomy for people with uncomplicated biliary colic due to gallstones. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until March 2013. SELECTION CRITERIA: We included only randomised clinical trials, irrespective of language and publication status. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data. We sought to include data on short-term mortality (30-day mortality or in-hospital mortality), bile duct injury, other serious adverse events, quality of life, conversion to open cholecystectomy, length of hospital stay, operating time, and return to work. We planned to calculate the risk ratio with 95% confidence interval (CI) for dichotomous outcomes and mean difference (MD) with 95% CI for continuous outcomes using RevMan and based on intention-to-treat analysis when data were available. Since only one trial contributed data to this review, Fisher's exact test was used for binary outcomes. A P value of < 0.05 was considered statistically significant. MAIN RESULTS: Only one trial including 75 participants (average age: 43 years; females: 65% of participants), randomised to early laparoscopic cholecystectomy (less than 24 hours after diagnosis) (n = 35) or delayed laparoscopic cholecystectomy (mean waiting period of 4.2 months) (n = 40), contributed information to this review. The trial had a high risk of bias. Information on the outcome mortality was available for the 75 participants. Information on serious adverse events was available for 68 participants (28 people in the early group and 40 people in the delayed group). The other outcomes were available for 28 participants in the early laparoscopic cholecystectomy group and 35 participants in the delayed laparoscopic cholecystectomy group. There were no deaths in the early group (0/35) (0%) versus 1/40 (2.5%) in the delayed laparoscopic cholecystectomy group (P > 0.9999). There was no bile duct injury in either group. There were no serious adverse events related to the surgery in either group. During the waiting period, complications developed in the delayed laparoscopic cholecystectomy group. The complications that the participants suffered included pancreatitis (n = 1), empyema of the gallbladder (n = 1), gallbladder perforation (n = 1), acute cholecystitis (n = 2), cholangitis (n = 2), obstructive jaundice (n = 2), and recurrent biliary colic (requiring hospital visits) (n = 5). In total, 14 participants required hospital admissions for the above symptoms. All of these admissions occurred in the delayed group as all the participants were operated on within 24 hours in the early group. The proportion of people who developed serious adverse events was 0/28 (0%) in the early group, which was significantly lower than in the delayed laparoscopic cholecystectomy group 9/40 (22.5%) (P = 0.0082). This trial did not report quality of life or return to work. There was no significant difference in the proportion of people who required conversion to open cholecystectomy in the early group 0/28 (0%) compared with the delayed group (6/35 or 17.1%) (P = 0.0743). There was a statistically significant shorter hospital stay in the early group than in the delayed group (MD -1.25 days, 95% CI -2.05 to -0.45). There was a statistically significant shorter operating time in the early group than the delayed group (MD -14.80 minutes, 95% CI -18.02 to -11.58). AUTHORS' CONCLUSIONS: Based on evidence from only one high-bias risk trial, it appears that early laparoscopic cholecystectomy (less than 24 hours after diagnosis of biliary colic) decreases the morbidity during the waiting period for elective laparoscopic cholecystectomy (mean waiting time 4.2 months), the hospital stay, and operating time. Further randomised clinical trials are necessary to confirm or refute these findings, and to determine if early laparoscopic cholecystectomy is better than the delayed laparoscopic cholecystectomy if the waiting time is shortened further.

T-tube drainage versus primary closure after laparoscopic common bile duct exploration.

BACKGROUND: T-tube drainage may prevent bile leak from the biliary tract following bile duct exploration and it offers post-operative access to the bile ducts for visualisation and exploration. Use of T-tube drainage after laparoscopic common bile duct (CBD) exploration is controversial. OBJECTIVES: To assess the benefits and harms of T-tube drainage versus primary closure after laparoscopic common bile duct exploration. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until April 2013. SELECTION CRITERIA: We included all randomised clinical trials comparing T-tube drainage versus primary closure after laparoscopic common bile duct exploration. DATA COLLECTION AND ANALYSIS: Two of four authors independently identified the studies for inclusion and extracted data. We analysed the data with both the fixed-effect and the random-effects model meta-analyses using Review Manager (RevMan) Analysis. For each outcome we calculated the risk ratio (RR), rate ratio (RaR), or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis. MAIN RESULTS: We included three trials randomising 295 participants: 147 to T-tube drainage versus 148 to primary closure. All trials had a high risk of bias. No one died during the follow-up period. There was no significant difference in the proportion of patients with serious morbidity (17/147 (weighted percentage 11.3%) in the T-tube drainage versus 9/148 (6.1%) in the primary closure group; RR 1.86; 95% CI 0.87 to 3.96; three trials), and no significant difference was found in the serious morbidity rates (weighted serious morbidity rate = 97 events per 1000 patients) in participants randomised to T-tube drainage versus serious morbidity rate = 61 events per 1000 patients in the primary closure group; RR 1.59; 95% CI 0.66 to 3.83; three trials). Quality of life was not reported in any of the trials. The operating time was significantly longer in the T-tube drainage group compared with the primary closure group (MD 21.22 minutes; 95% CI 12.44 minutes to 30.00 minutes; three trials). The hospital stay was significantly longer in the T-tube drainage group compared with the primary closure group (MD 3.26 days; 95% CI 2.49 days to 4.04 days; three trials). According to one trial, the participants randomised to T-tube drainage returned to work approximately eight days later than the participants randomised to the primary closure group (P < 0.005). AUTHORS' CONCLUSIONS: T-tube drainage appears to result in significantly longer operating time and hospital stay as compared with primary closure without any evidence of benefit after laparoscopic common bile duct exploration. Based on currently available evidence, there is no justification for the routine use of T-tube drainage after laparoscopic common bile duct exploration in patients with common bile duct stones. More randomised trials comparing the effects of T-tube drainage versus primary closure after laparoscopic common bile duct exploration may be needed. Such trials should be conducted with low risk of bias, assessing the long-term beneficial and harmful effects including long-term complications such as bile stricture and recurrence of common bile duct stones.

T-tube drainage versus primary closure after open common bile duct exploration.

BACKGROUND: Between 5% and 11% of people undergoing cholecystectomy have common bile duct stones. Stones may be removed at the time of cholecystectomy by opening and clearing the common bile duct. The optimal technique is unclear. OBJECTIVES: The aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after open common bile duct exploration for common bile duct stones. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until April 2013. SELECTION CRITERIA: We included all randomised clinical trials comparing T-tube drainage versus primary closure after open common bile duct exploration. DATA COLLECTION AND ANALYSIS: Two of four authors independently identified the studies for inclusion and extracted data. We analysed the data with both the fixed-effect and the random-effects model using Review Manager (RevMan) analyses. For each outcome we calculated the risk ratio (RR), rate ratio (RaR), or mean difference (MD) with 95% confidence interval (CI) based on intention-to-treat analysis. MAIN RESULTS: We included six trials randomising 359 participants, 178 to T-tube drainage and 181 to primary closure. All trials were at high risk of bias. There was no significant difference in mortality between the two groups (4/178 (weighted percentage 1.2%) in the T-tube group versus 1/181 (0.6%) in the primary closure group; RR 2.25; 95% CI 0.55 to 9.25; six trials). There was no significant difference in the serious morbidity rate between the two groups (24/136 (weighted serious morbidity rate, 145 events per 1000 patients) in the T-tube group versus 9/136 (weighted serious morbidity rate, 66 events per 1000 patients) in the primary closure group; RaR 2.19; 95% CI 0.98 to 4.91; four trials). Quality of life and return to work were not reported in any of the trials. The operating time was significantly longer in the T-tube drainage group compared with the primary closure group (MD 28.90 minutes; 95% CI 17.18 to 40.62 minutes; one trial). The hospital stay was significantly longer in the T-tube drainage group compared with the primary closure group (MD 4.72 days; 95% CI 0.83 days to 8.60 days; five trials). AUTHORS' CONCLUSIONS: T-tube drainage appeared to result in significantly longer operating time and hospital stay compared with primary closure without any apparent evidence of benefit on clinically important outcomes after open common bile duct exploration. Based on the currently available evidence, there is no justification for the routine use of T-tube drainage after open common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well designed randomised clinical trials. More randomised trials comparing the effects of T-tube drainage versus primary closure after open common bile duct exploration may be needed. Such trials should be conducted with low risk of bias and assessing the long-term beneficial and harmful effects of T-tube drainage, including long-term complications such as bile stricture and recurrence of common bile duct stones.

Somatostatin analogues for pancreatic surgery.

BACKGROUND: Pancreatic resections are associated with high morbidity (30% to 60%) and mortality (5%). Synthetic analogues of somatostatin are advocated by some surgeons to reduce complications following pancreatic surgery; however, their use is controversial. OBJECTIVES: To determine whether prophylactic somatostatin analogues should be used routinely in pancreatic surgery. SEARCH METHODS: We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 1), MEDLINE, EMBASE and Science Citation Index Expanded to February 2013. SELECTION CRITERIA: We included randomised controlled trials comparing prophylactic somatostatin or one of its analogues versus no drug or placebo during pancreatic surgery (irrespective of language or publication status). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and independently extracted data. We analysed data with both the fixed-effect and random-effects models using Review Manager (RevMan). We calculated the risk ratio (RR), mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) based on an intention-to-treat or available case analysis. When it was not possible to perform either of the above, we performed a per protocol analysis. MAIN RESULTS: We identified 21 trials (19 trials of high risk of bias) involving 2348 people. There was no significant difference in the perioperative mortality (RR 0.80; 95% CI 0.56 to 1.16; n = 2210) or the number of people with drug-related adverse effects between the two groups (RR 2.09; 95% CI 0.83 to 5.24; n = 1199). Quality of life was not reported in any of the trials. The overall number of participants with postoperative complications was significantly lower in the somatostatin analogue group (RR 0.70; 95% CI 0.61 to 0.80; n = 1903) but there was no significant difference in the re-operation rate (RR 1.26; 95% CI 0.58 to 2.70; n = 687) or hospital stay (MD -1.29 days; 95% CI -2.60 to 0.03; n = 1314) between the groups. The incidence of pancreatic fistula was lower in the somatostatin analogue group (RR 0.66; 95% CI 0.55 to 0.79; n = 2206). The proportion of these fistulas that were clinically significant was not mentioned in most trials. On inclusion of trials that clearly distinguished clinically significant fistulas, there was no significant difference between the two groups (RR 0.69; 95% CI 0.38 to 1.28; n = 292). AUTHORS' CONCLUSIONS: Somatostatin analogues may reduce perioperative complications but do not reduce perioperative mortality. Further adequately powered trials with low risk of bias are necessary. Based on the current available evidence, somatostatin and its analogues are recommended for routine use in people undergoing pancreatic resection.

Somatostatin analogues for pancreatic surgery.

BACKGROUND: Pancreatic resections are associated with high morbidity (30% to 60%) and mortality (5%). Synthetic analogues of somatostatin are advocated by some surgeons to reduce complications following pancreatic surgery, however their use is controversial. OBJECTIVES: To determine whether prophylactic somatostatin analogues should be used routinely in pancreatic surgery. SEARCH METHODS: We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 12), MEDLINE, EMBASE and Science Citation Index Expanded to December 2011. SELECTION CRITERIA: We included randomised controlled trials comparing prophylactic somatostatin or one of its analogues versus no drug or placebo during pancreatic surgery (irrespective of language or publication status). DATA COLLECTION AND ANALYSIS: Two authors independently assessed trials for inclusion and independently extracted data. We analysed data with both the fixed-effect and random-effects models using Review Manager (RevMan). We calculated the risk ratio (RR), mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) based on an intention-to-treat or available case analysis. When it was not possible to perform either of the above, we performed per protocol analysis. MAIN RESULTS: We identified 19 trials (17 trials of high risk of bias) involving 2245 patients. There was no significant difference in the perioperative mortality (RR 0.80; 95% CI 0.56 to 1.16; N = 2210) or the number of patients with drug-related adverse effects between the two groups (RR 2.09; 95% CI 0.83 to 5.24; N = 1199). Quality of life was not reported in any of the trials. The overall number of patients with postoperative complications was significantly lower in the somatostatin analogue group (RR 0.69; 95% CI 0.60 to 0.79; N = 1858) but there was no significant difference in the re-operation rate (RR 1.26; 95% CI 0.58 to 2.70; N = 687) or hospital stay (MD -1.04 days; 95% CI -2.54 to 0.46; N = 1269) between the groups. The incidence of pancreatic fistula was lower in the somatostatin analogue group (RR 0.63; 95% CI 0.52 to 0.77; N = 2161). The proportion of these fistulas that were clinically significant was not mentioned in most trials. On inclusion of trials that clearly distinguished clinically significant fistulas, there was no significant difference between the two groups (RR 0.69; 95% CI 0.34 to 1.41; N = 247). AUTHORS' CONCLUSIONS: Somatostatin analogues may reduce perioperative complications but do not reduce perioperative mortality. Further adequately powered trials with low risk of bias are necessary. Based on the current available evidence, somatostatin and its analogues are recommended for routine use in patients undergoing pancreatic resection.

Abdominal lift for laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy (key-hole removal of the gallbladder) is now the most often used method for treatment of symptomatic gallstones. Several cardiopulmonary changes (decreased cardiac output, pulmonary compliance, and increased peak airway pressure) occur during pneumoperitoneum, which is now introduced to allow laparoscopic cholecystectomy. These cardiopulmonary changes may not be tolerated in individuals with poor cardiopulmonary reserve. OBJECTIVES: To assess the benefits and harms of abdominal wall lift compared with pneumoperitoneum in patients undergoing laparoscopic cholecystectomy. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until January 2012. SELECTION CRITERIA: We included all randomised clinical trials comparing abdominal wall lift (with or without pneumoperitoneum) versus pneumoperitoneum. DATA COLLECTION AND ANALYSIS: We calculated the risk ratio (RR), rate ratio (RaR), or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis with both the fixed-effect and the random-effects models using RevMan software. MAIN RESULTS: For abdominal wall lift with pneumoperitoneum versus pneumoperitoneum, a total of 156 participants (all with low anaesthetic risk) who underwent elective laparoscopic cholecystectomy were randomised in six trials to abdominal wall lift with pneumoperitoneum (n = 65) versus pneumoperitoneum only (n = 66). One trial which included 25 patients did not state the number of patients in each group. All six trials had a high risk of bias. There was no mortality or conversion to open cholecystectomy in any of the patients in the trials that reported these outcomes. There was no significant difference in the rate of serious adverse events between the two groups (2 trials; 2/29 events (0.069 events per patient) versus 2/29 events (0.069 events per patient); rate ratio 1.00; 95% CI 0.17 to 5.77). None of the trials reported quality of life, the proportion of patients discharged as day-patient laparoscopic cholecystectomies, or pain between four and eight hours after the operation. There was no significant difference in the operating time between the two groups (4 trials; 53 patients versus 54 patients; 13.39 minutes longer (2.73 less to 29.51 longer) in the abdominal wall lift with pneumoperitoneum group and 100 minutes in the pneumoperitoneum group).For abdominal wall lift versus pneumoperitoneum, a total of 774 participants (the majority with low anaesthetic risk) who underwent elective laparoscopic cholecystectomy were randomised in 18 trials to abdominal wall lift without pneumoperitoneum (n = 332) versus pneumoperitoneum (n = 358). One trial which included 84 patients did not state the number of patients in each group. All the trials had a high risk of bias. There was no mortality in any of the trials that reported this outcome. There was no significant difference in the rate of serious adverse events between the two groups (6 trials; 5/172 events (weighted number of events per patient = 0.020 events) versus 2/171 events (0.012 events per patient); rate ratio 1.73; 95% CI 0.35 to 8.61). None of the trials reported quality of life or pain between four and eight hours after the operation. There was no significant difference in the proportion of patients who underwent conversion to open cholecystectomy (11 trials; 5/225 (weighted proportion 2.3%) versus 7/235 (3.0%); RR 0.76; 95% CI 0.26 to 2.21). The operating time was significantly longer in the abdominal wall lift group than the pneumoperitoneum group (16 trials; 6.87 minutes longer (4.74 to 9.00 longer) in the abdominal wall lift group; 75 minutes in the pneumoperitoneum group). There was no significant difference in the proportion of patients who were discharged as day-patient laparoscopic cholecystectomy patients (2 trials; 15/31 (weighted proportion 48.5%) versus 9/31 (29%); RR 1.67; 95% CI 0.85 to 3.26). AUTHORS' CONCLUSIONS: Abdominal wall lift does not seem to offer an advantage over pneumoperitoneum in any of the patient-oriented outcomes for laparoscopic cholecystectomy in patients with low anaesthetic risk. It may increase costs by increasing the operating time. Hence it cannot be recommended routinely. The safety of abdominal wall lift is yet to be established. More research on the topic is needed because of the risk of bias in the included trials and because of the risk of type I and type II random errors because of the few patients included in the trials. Such trials ought to include patients at higher anaesthetic risk. Furthermore, such trials ought to include blinded assessment of outcome measures.

Veno-venous bypass versus none for liver transplantation.

BACKGROUND: Veno-venous bypass is used to overcome the effects of clamping of the inferior vena cava and portal vein during liver transplanation. The routine use of veno-venous bypass is, however, controversial. OBJECTIVES: To compare the benefits and harms of veno-venous bypass (irrespective of open or percutaneous technique; heparin-coated or no heparin-coating) versus no veno-venous bypass during liver transplantation. To compare the benefits and harms of the different techniques of veno-venous bypass during liver transplantation. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until December 2010. SELECTION CRITERIA: We included randomised clinical trials comparing veno-venous bypass during liver transplantation (irrespective of language or publication status). DATA COLLECTION AND ANALYSIS: Two authors independently assessed trials for inclusion and independently extracted data. We analysed the data with both the fixed-effect and the random-effects models using RevMan Analysis. For continuous outcomes, we calculated the mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat or available case analysis. For binary outcomes, we used the Fisher's exact test since none of the comparisons of binary outcomes included more than one trial. MAIN RESULTS: We identified three trials with high risk of bias which compared veno-venous bypass (n = 65) versus no veno-venous bypass (n = 66). None of the trials reported patient or graft survival. There were no significant differences regarding renal failure or blood transfusion requirements between the two groups. None of the trials reported on the morbidity related to veno-venous bypass or the requirement of veno-venous bypass in the control group.We identified one trial with high risk of bias which compared percutaneous (n = 20) versus open technique (n =19) of veno-venous bypass. The patient or graft survival was not reported. There was no difference in veno-venous bypass related morbidity between the two groups. The operating time was significantly shorter in the percutaneous technique group (MD -59 minutes; 95% CI -102 to -16). AUTHORS' CONCLUSIONS: There is no evidence to support or refute the use of veno-venous bypass in liver transplantation. There is no evidence to prefer any particular technique of veno-venous bypass in liver transplantation.

Meta-analysis of randomized controlled trials on the effectiveness of somatostatin analogues for pancreatic surgery: a Cochrane review.

BACKGROUND: The use of synthetic analogues of somatostatin following pancreatic surgery is controversial. The aim of this meta-analysis is to determine whether prophylactic somatostatin analogues (SAs) should be used routinely in pancreatic surgery. METHODS: Randomized controlled trials were identified from the Cochrane Library Trials Register, MEDLINE, EMBASE, Science Citation Index Expanded and reference lists. Data were extracted from these trials by two independent reviewers. The risk ratio (RR), mean difference (MD) and standardized mean difference (SMD) were calculated with 95% confidence intervals (95% CIs) based on intention-to-treat or available case analysis. RESULTS: Seventeen trials involving 2143 patients were identified. The overall number of patients with postoperative complications was lower in the SA group (RR 0.71, 95% CI 0.62-0.82), but there was no difference between the groups in perioperative mortality (RR 1.04, 95% CI 0.68-1.59), re-operation rate (RR 1.15, 95% CI 0.56-2.36) or hospital stay (MD -1.04 days, 95% CI -2.54 to 0.46). The incidence of pancreatic fistula was lower in the SA group (RR 0.64, 95% CI 0.53-0.78). The proportion of these fistulas that were clinically significant is not clear. Analysis of results of trials that clearly distinguished clinically significant fistulas revealed no difference between the two groups (RR 0.69, 95% CI 0.34-1.41). Subgroup analysis revealed a shorter hospital stay in the SA group than among controls for patients with malignant aetiology (MD -7.57 days, 95% CI -11.29 to -3.84). CONCLUSIONS: Somatostatin analogues reduce perioperative complications but do not reduce perioperative mortality. However, they do shorten hospital stay in patients undergoing pancreatic surgery for malignancy. Further adequately powered trials of low risk of bias are necessary.

Somatostatin analogues for pancreatic surgery.

BACKGROUND: Pancreatic resections are associated with high morbidity (30% to 60%) and mortality (5%). Synthetic analogues of somatostatin are advocated by some surgeons to reduce complications following pancreatic surgery, however their use is controversial. OBJECTIVES: To determine whether prophylactic somatostatin analogues should be used routinely in pancreatic surgery. SEARCH STRATEGY: We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, issue 4), MEDLINE, EMBASE and Science Citation Index Expanded to November 2009. SELECTION CRITERIA: We included randomised controlled trials comparing prophylactic somatostatin or one of its analogues versus no drug or placebo during pancreatic surgery (irrespective of language or publication status). DATA COLLECTION AND ANALYSIS: Two authors independently assessed trials for inclusion and independently extracted data. We analysed data with both the fixed-effect and the random-effects models using Review Manager (RevMan). We calculated the risk ratio (RR), mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) based on an intention-to-treat or available case analysis. When it was not possible to perform either of the above, we performed per protocol analysis. MAIN RESULTS: We identified 17 trials (of high risk of bias) involving 2143 patients. The overall number of patients with postoperative complications was lower in the somatostatin analogue group (RR 0.71; 95% CI 0.62 to 0.82) but there was no difference in the perioperative mortality, re-operation rate or hospital stay between the groups. The incidence of pancreatic fistula was lower in the somatostatin analogue group (RR 0.64; 95% CI 0.53 to 0.78). The proportion of these fistulas that were clinically significant was not mentioned in most trials. On inclusion of trials that clearly distinguished clinically significant fistulas, there was no difference between the two groups (RR 0.69; 95% CI 0.34 to 1.41). Subgroup analysis revealed a shorter hospital stay in the somatostatin analogue group than the controls for patients with malignant aetiology (MD -7.57; 95% CI -11.29 to -3.84). AUTHORS' CONCLUSIONS: Somatostatin analogues reduce perioperative complications but do not reduce perioperative mortality. In those undergoing pancreatic surgery for malignancy, they shorten hospital stay. Further adequately powered trials with low risk of bias are necessary. Based on the current available evidence, somatostatin and its analogues are recommended for routine use in patients undergoing pancreatic resection for malignancy. There is currently no evidence to support their routine use in pancreatic surgeries performed for other indications.