Postoperative inflammatory response in colorectal cancer surgery: a meta-analysis.

PURPOSE: Surgical removal of the cancerous tissue remains the cornerstone of curative treatment for colorectal cancer and results in an inflammatory response. An exaggerated inflammatory response has been implicated in the promotion of tumor proliferation and has shown associations with postoperative complications. Literature on the preferred surgical technique to minimize inflammatory response is inconclusive. Therefore, the aim of this study was to assess the inflammatory response and postoperative incidence of infectious complications following surgery for colorectal cancer. METHODS: Embase, PubMed, and Cochrane databases were searched for RCTs that reported inflammatory parameters as a function of surgical modality only. Data related to CRP or IL-6 levels on postoperative days 1 and 3 and data related to postoperative infections were subject to a pairwise meta-analysis to compare open versus laparoscopic techniques. RESULTS: The literature search and screening process yielded 4151 studies. Ten studies met criteria, including 568 patients. Only studies on laparoscopic and open surgery were found. Pooled analyses found lower Il-6 and CRP levels on postoperative day 1 and lower CRP levels on postoperative day 3 for laparoscopic surgery compared to open surgery. However, there was no difference in incidence of postoperative infectious complications. CONCLUSION: The findings of this study indicate a superior inflammatory profile for laparoscopic surgery compared to an open approach for colorectal cancer surgery. For future research, it would be worthwhile to conduct a randomized controlled trial to compare the postoperative inflammatory response and related clinical outcomes between minimally invasive surgical approaches, including laparoscopic and robot-assisted surgery.

The effect of surgical strategy in difficult cholecystectomy cases on postoperative complications outcome: a value-based healthcare comparative study.

BACKGROUND: In patients undergoing laparoscopic cholecystectomy (LC) for complicated biliary disease, complication rates increase up to 30%. The aim of this study is to assess the effect of differences in surgical strategy comparing outcome data of two large volume hospitals. METHODS: A prospective database was created for all the patients who underwent a LC in two large volume hospitals between January 2017 and December 2018. In cases of difficult cholecystectomy in clinic A, regular LC or conversion were surgical strategies. In clinic B, laparoscopic subtotal cholecystectomy was performed as an alternative in difficult cases. The difficulty of the cholecystectomy (score 1-4) and surgical strategy (regular LC, subtotal cholecystectomy, conversion) were scored. Postoperative complications, reinterventions, and ICU admission were assessed. For predicting adverse postoperative complication outcomes, uni- and multivariable analyses were used. RESULTS: A total of 2104 patients underwent a LC in the study period of which 974 were from clinic A and 1130 were from clinic B. In total, 368 procedures (17%) were scored as a difficult cholecystectomy. In clinic A, more conversions were performed (4.4%) compared to clinic B (1.0%; p < 0.001). In clinic B, more subtotal laparoscopic cholecystectomies were performed (1.8%) compared to clinic A (0%; p = < 0.001). Overall complication rate was 8.2% for clinic A and 10.2% for clinic B (p = 0.121). Postoperative complication rates per group for regular LC, conversion, and subtotal cholecystectomy in difficult cholecystectomies were 45 (15%), 12 (24%), and 7 (35%; p = 0.035), respectively. The strongest predictor for Clavien-Dindo grade 3-5 complication was subtotal cholecystectomy. CONCLUSION: Surgical strategy in case of a difficult cholecystectomy seems to have an important impact on postoperative complication outcome. The effect of a subtotal cholecystectomy on complications is of great concern.

Prospective multicentre study of a new bowel obstruction treatment in colorectal surgery: Reduced morbidity and mortality.

INTRODUCTION: Bowel obstruction patients are at increased risk of emergency surgery and have poor nutritional and physical conditions. These patients could benefit from prehabilitation and prevention of emergency surgery. This study assessed the effect of a multimodal obstruction treatment for bowel obstruction patients in colorectal surgery on the risk of emergency surgery and postoperative morbidity and mortality. MATERIALS AND METHODS: This multicenter observational cohort study included all consecutive bowel obstruction patients who received obstruction treatment (obstruction protocol) in the period 2019-2020 in two Dutch hospitals. Benign and malignant causes of bowel obstruction were included. Treatment consisted of 1. dietary adjustments, 2. postponing surgery for three weeks, 3. laxatives, and 4. prehabilitation. We compared emergency surgery and postoperative morbidity and mortality rates to known rates from the literature. RESULTS: Eighty-nine patients were included: obstruction treatment was successful in 77 patients (87%) who underwent elective surgery and unsuccessful in 12 patients (13%) who underwent emergency surgery. Sixty-six (74%) had colorectal cancer, and 22 (25%) had benign disease. Thirty-day mortality of 0% in our study was significantly lower than the national average of 4% in colorectal cancer patients in the Netherlands (p = 0.049). Anastomotic leakage rate was 3%, severe complications (Clavien-Dindo ≥ III) 8%, and bowel perforation 0%. These rates did not differ significantly from rates reported in literature. CONCLUSION: The obstruction treatment prevented emergency surgery in most patients with bowel obstruction and reduced postoperative morbidity and mortality. The obstruction treatment seems to be a safe and efficient alternative to emergency surgery.

Treatment of Pregnant Women With Fear of Childbirth Using EMDR Therapy: Results of a Multi-Center Randomized Controlled Trial.

Fear of childbirth (FoC) occurs in 7. 5% of pregnant women and has been associated with adverse feto-maternal outcomes. Eye Movement Desensitization and Reprocessing (EMDR) therapy has proven to be effective in the treatment of posttraumatic stress disorder (PTSD) and anxiety; however, its effectiveness regarding FoC has not yet been established. The aim was to determine the safety and effectiveness of EMDR therapy for pregnant women with FoC. This single-blind RCT (the OptiMUM-study, www.trialregister.nl, NTR5122) was conducted in the Netherlands. FoC was defined as a score ≥85 on the Wijma Delivery Expectations Questionnaire (WDEQ-A). Pregnant women with FoC and a gestational age between 8 and 20 weeks were randomly assigned to EMDR therapy or care-as-usual (CAU). The severity of FoC was assessed using the WDEQ-A. Safety was indexed as worsening of FoC symptoms, dropout, serious adverse events, or increased suicide risk. We used linear mixed model analyses to compare groups. A total of 141 women were randomized (EMDR n = 70; CAU n = 71). No differences between groups were found regarding safety. Both groups showed a very large (EMDR d = 1.36) or large (CAU d = 0.89) reduction of FoC symptoms with a mean decrease of 25.6 (EMDR) and 17.4 (CAU) points in WDEQ-A sum score. No significant difference between both groups was found (p = 0.83). At posttreatment, 72.4% (EMDR) vs. 59.6% (CAU) no longer met the criteria for FoC. In conclusion, the results are supportive of EMDR therapy as a safe and effective treatment of FoC during pregnancy, albeit without significant beneficial effects of EMDR therapy over and above those of CAU. Therefore, the current study results do not justify implementation of EMDR therapy as an additional treatment in this particular setting.

Increased long-term mortality after emergency colon resections.

AIM: Emergency surgery is a known predictor for 30-day mortality. However, its relationship with long-term mortality is still a matter of debate. The aim of this study was to analyse the effect of emergency surgery compared with elective surgery on long-term survival. METHOD: Data from the Dutch Colorectal Audit and the Dutch Cancer Centre registry of a large nonacademic teaching hospital were used to analyse outcomes of patients who underwent surgery for colon cancer from 2009 until 2017. Univariable and multivariable Cox regression were used to assess the effect of emergency surgery on long-term mortality with adjustment for patient, tumour and treatment characteristics. RESULTS: A total of 1139 patients with a median follow-up of 40 months (interquartile range 23-65 months) were included. Emergency surgery was performed in 158 patients (14%). The 5-year survival after emergency surgery was 46% compared with 72% after elective surgery. After adjusting for baseline differences there was an independent and significant association between emergency surgery and increased long-term mortality (hazard ratio 1.79, 95% CI 1.28-2.51, P = 0.001). CONCLUSION: Emergency surgery for colon cancer seems to lead to a significantly increased risk of long-term mortality compared with elective surgery. Detection and treatment of early symptoms that can lead to emergency surgery might be the way forward.

Nerve Sparing during Robot-Assisted Radical Prostatectomy Increases the Risk of Ipsilateral Positive Surgical Margins.

PURPOSE: Available published studies evaluating the association between nerve sparing robot-assisted radical prostatectomy and risk of ipsilateral positive surgical margins were subject to selection bias. In this study we overcome these limitations by using multivariable regression analysis. MATERIALS AND METHODS: Patients undergoing robot-assisted radical prostatectomy for prostate cancer at 4 institutions from 2013 to 2018 were included in the study. A multilevel logistic random intercept model, including covariates on patient level and side specific factors on prostate lobe level, was used to evaluate the association between nerve sparing and risk of ipsilateral positive margins. RESULTS: A total of 5,148 prostate lobes derived from 2,574 patients who underwent robot-assisted radical prostatectomy were analyzed. Multivariable analysis showed nerve sparing was an independent predictor for ipsilateral positive margins (OR 1.42, 95% CI 1.14-1.82). Other significant predictors for positive margins were prostate specific antigen density (OR 3.64, 95% CI 2.36-5.90) and side specific covariates including highest preoperative ISUP (International Society of Urological Pathology) biopsy grade (OR 1.58, 95% CI 1.13-2.53; OR 1.62, 95% CI 1.13-2.69; OR 2.11, 95% CI 1.39-3.59 and OR 4.43, 95% CI 3.17-10.12 for ISUP grade 2, 3, 4 and 5, respectively), presence of extraprostatic extension on magnetic resonance imaging (OR 1.42, 95% CI 1.03-1.91) and percentage of positive cores on systematic biopsy (OR 3.82, 95% CI 2.50-5.86). CONCLUSIONS: Nerve sparing was associated with an increased risk of ipsilateral positive surgical margins. The increased risk of positive margins should be considered when counseling patients who opt for nerve sparing robot-assisted radical prostatectomy.

Promising results of a new treatment in patients with bowel obstruction in colorectal surgery.

INTRODUCTION: Bowel obstruction increases risk of emergency surgery and leads to suboptimal physical and nutritional condition. Preventing emergency surgery and prehabilitation might improve outcomes. This pilot study aimed to examine the effect of a multimodal obstruction protocol for bowel obstruction patients on the risk of emergency surgery and postoperative morbidity and mortality. MATERIALS AND METHODS: All bowel obstruction patients treated according to the obstruction protocol in the period 2013-2017 were included in this uncontrolled observational cohort study. Benign and malignant causes of bowel obstruction were included. The protocol consisted of: 1. specific dietary adjustments to reduce prestenotic dilatation, 2. oral laxatives and 3. prehabilitation. Emergency surgery and postoperative morbidity and mortality rates were compared to known rates from the literature. RESULTS: Sixty-one patients were included: 44 (72%) were treated for colorectal cancer and 17 (28%) for Crohn's disease or diverticulitis. Four patients (7%) underwent emergency surgery. Primary anastomosis was constructed in 49 out of 57 elective patients (86%). Severe complications (Clavien-Dindo ≥ III) occurred in four patients (7%). No bowel perforation, anastomotic leakages or 30-day mortality was observed. These rates were much lower than rates reported in the literature after surgery for colorectal cancer (3% bowel perforation, 8% anastomotic leakage, 4% 30-day mortality, 15% severe complications) and benign disease (30-day mortality 17%, severe complications 7%). CONCLUSION: Using the obstruction protocol in patients with bowel obstruction reduced emergency surgery and postoperative morbidity and mortality in this pilot study. This protocol seems to be a viable and efficient alternative to emergency surgery.

Routine postoperative intensive care unit admission after colorectal cancer surgery for the elderly patient reduces postoperative morbidity and mortality.

AIM: Older colorectal cancer (CRC) patients are at increased risk of postoperative morbidity and mortality. Routine postoperative overnight intensive care unit (ICU) admission might reduce this risk. This study aimed to examine the effect of routine overnight ICU admission after CRC surgery on postoperative adverse outcomes and costs in patients aged 80 years or older. METHODS: Patients aged 80 years or older who underwent CRC surgery in our centre were included in this observational cohort study. All patients in the period 2014-2017 with routine overnight ICU admission were assigned to the ICU cohort; all patients in the period 2009-2013 were assigned to the non-ICU cohort. Multivariable logistic regression was performed to compare the primary composite end-point (30-day mortality, serious complications and readmission) between the groups. Cost data from the literature were used to perform a cost analysis. RESULTS: A total of 242 patients were included, 125 in the ICU cohort and 117 in the non-ICU cohort. Routine overnight ICU admission was associated with a reduced risk of the composite end-point (OR 0.44, 95% CI 0.22-0.87, P = 0.02) after adjusting for important confounders. In the ICU cohort 28% of patients experienced ICU events requiring intervention; this was not associated with postoperative morbidity or mortality. The 9% reduction in the incidence of serious complications in the ICU cohort is sufficient to offset the additional costs of routine overnight ICU admission. CONCLUSION: Routine overnight ICU admission after CRC surgery in patients aged 80 years and older is associated with reduced risk of postoperative mortality and morbidity and seems to be cost-effective.

The OptiMUM-study: EMDR therapy in pregnant women with posttraumatic stress disorder after previous childbirth and pregnant women with fear of childbirth: design of a multicentre randomized controlled trial.

Background: Approximately 3% of women develop posttraumatic stress disorder (PTSD) after giving birth, and 7.5% of pregnant women show a pathological fear of childbirth (FoC). FoC or childbirth-related PTSD during (a subsequent) pregnancy can lead to a request for an elective caesarean section as well as adverse obstetrical and neonatal outcomes. For PTSD in general, and several subtypes of specific phobia, eye movement desensitization and reprocessing (EMDR) therapy has been proven effective, but little is known about the effects of applying EMDR during pregnancy. Objective: To describe the protocol of the OptiMUM-study. The main aim of the study is to determine whether EMDR therapy is an effective and safe treatment for pregnant women with childbirth-related PTSD or FoC. In addition, the cost-effectiveness of this approach will be analysed. Method: The single-blind OptiMUM-study consists of two two-armed randomized controlled trials (RCTs) with overlapping design. In several hospitals and community midwifery practices in Amsterdam, the Netherlands, all eligible pregnant women with a gestational age between eight and 20 weeks will be administered the Wijma delivery expectations questionnaire (WDEQ) to asses FoC. Multiparous women will also receive the PTSD checklist for DSM-5 (PCL-5) to screen for possible PTSD. The clinician administered PTSD scale (CAPS-5) will be used for assessing PTSD according to DSM-5 in women scoring above the PCL-5 cut-off value. Fifty women with childbirth-related PTSD and 120 women with FoC will be randomly allocated to either EMDR therapy carried out by a psychologist or care-as-usual. Women currently undergoing psychological treatment or women younger than 18 years will not be included. Primary outcome measures are severity of childbirth-related PTSD or FoC symptoms. Secondary outcomes are percentage of PTSD diagnoses, percentage caesarean sections, subjective childbirth experience, obstetrical and neonatal complications, and health care costs. Results: The results are meant to provide more insight about the safety and possible effectiveness of EMDR therapy during pregnancy for women with PTSD or FoC. Conclusion: This study is the first RCT studying efficacy and safety of EMDR in pregnant women with PTSD after childbirth or Fear of Childbirth.

Cost-effectiveness of same-admission versus interval cholecystectomy after mild gallstone pancreatitis in the PONCHO trial.

BACKGROUND: Same-admission cholecystectomy is indicated after gallstone pancreatitis to reduce the risk of recurrent disease or other gallstone-related complications, but its impact on overall costs is unclear. This study analysed the cost-effectiveness of same-admission versus interval cholecystectomy after mild gallstone pancreatitis. METHODS: In a multicentre RCT (Pancreatitis of biliary Origin: optimal timiNg of CHOlecystectomy; PONCHO) patients with mild gallstone pancreatitis were randomized before discharge to either cholecystectomy within 72 h (same-admission cholecystectomy) or cholecystectomy after 25-30 days (interval cholecystectomy). Healthcare use of all patients was recorded prospectively using clinical report forms. Unit costs of resources used were determined, and patients completed multiple Health and Labour Questionnaires to record pancreatitis-related absence from work. Cost-effectiveness analyses were performed from societal and healthcare perspectives, with the costs per readmission prevented as primary outcome with a time horizon of 6 months. RESULTS: All 264 trial participants were included in the present analysis, 128 randomized to same-admission cholecystectomy and 136 to interval cholecystectomy. Same-admission cholecystectomy reduced the risk of acute readmission for recurrent gallstone-related complications from 16·9 to 4·7 per cent (P = 0·002). Mean total costs from a societal perspective were €234 (95 per cent c.i. -1249 to 738) less per patient in the same-admission cholecystectomy group. Same-admission cholecystectomy was superior to interval cholecystectomy, with a societal incremental cost-effectiveness ratio of -€1918 to prevent one readmission for gallstone-related complications. CONCLUSION: In mild biliary pancreatitis, same-admission cholecystectomy was more effective and less costly than interval cholecystectomy.

Anticipation of complications after laparoscopic cholecystectomy: prediction of individual outcome.

BACKGROUND: Complication rates after a laparoscopic cholecystectomy are still up to 10 %. Knowledge of individual patient risk profiles could help to reduce morbidity. AIM: The aim of this study is to create risk profiles for specific complications to anticipate on individual outcome. PATIENTS AND METHODS: Individual patient outcome for a specific post-operative complication was assessed from a retrospective database of two major teaching hospitals, using uni- and multivariable analyses. RESULTS: A total of 4359 patients were included of which 346 developed one or more complications (8 %). Five risk profiles were found to predict specific complications: older patients (>65 year) are at risk for pneumonia (OR 7.0, 95 % CI 3.3-15.0, p < 0.001) and bleeding (OR 2.2, 95 % CI 1.2-3.9, p = 0.014), patients with acute cholecystitis are at risk for intra-abdominal abscess (OR 5.9, 95 % CI 3.4-10.1, p < 0.001), bile leakage (OR 3.6, 95 % CI 2.0-6.6, p < 0.001) and pneumonia (OR 3.5, 95 % CI 1.6-7.6, p < 0.002), previous history of cholecystitis is predictive for wound infection (OR 5.1, 95 % CI, (2.7-9.7), p < 0.001), intra-abdominal abscess (OR 6.1, 95 % CI 2.8-13.8, p < 0.001), post-operative bleeding (OR 4.8, 95 % CI 2.1-11.1, p < 0.001), bile leakage (OR 7.2, 95 % CI 3.4-15.4, p < 0.001) and pneumonia (OR 3.9, 95 % CI 1.3-11.9, p = 0.018), pre-operative ERCP is predictive for intra-abdominal abscess (OR 3.3, 95 % CI 2.0-5.7, p < 0.001), post-operative bleeding (OR 2.1, 95 % CI 1.2-3.9, p = 0.058) and pneumonia (OR 3.8, 95 % CI 1.9-7.8, p = 0.001), and converted patients are at risk for wound infection (OR 4.0, 95 % CI 2.1-7.7, p < 0.001) and intra-abdominal abscess (OR 3.5, 95 % CI 1.6-7.7, p = 0.002). CONCLUSION: Individual risk prediction of outcome after laparoscopic cholecystectomy is feasible. This facilitates individual pre-operative doctor-patient communication and may tailor surgical strategies.

Carboxyhaemoglobin formation and ECG changes during hysteroscopic surgery, transurethral prostatectomy and tonsillectomy using bipolar diathermy.

Diathermy is known to produce a mixture of waste products including carbon monoxide. During transcervical hysteroscopic surgery, carbon monoxide might enter the circulation leading to the formation of carboxyhaemoglobin. In 20 patients scheduled for transcervical hysteroscopic resection of myoma or endometrium, carboxyhaemoglobin was measured before and at the end of the surgical procedure, and compared with levels measured in 20 patients during transurethral prostatectomy, and in 20 patients during tonsillectomy. Haemodynamic data, including ST-segment changes, were recorded. Levels of carboxyhaemoglobin increased significantly during hysteroscopic surgery from median (IQR [range]) 1.0% (0.7-1.4 [0.5-4.9])% to 3.5% (2.0-6.1 [1.3-10.3]%, p < 0.001), compared with levels during prostatectomy or tonsillectomy. Significant ST-segment changes were observed in 50% of the patients during hysteroscopic surgery. Significant correlations were observed between the increase in carboxyhaemoglobin and the maximum ST-segment change (ρ = -0.707, p < 0.01), between the increase in carboxyhaemoglobin and intravasation (ρ = 0.625; p < 0.01), and between intravasation and the maximum ST-segment change (ρ = -0.761; p < 0.01). The increased carboxyhaemoglobin levels during hysteroscopic surgery appear to be related to the amount of intravasation and this could potentially be a contributing factor to the observed ST-segment changes.

Cost-effectiveness and cost-utility of endovascular versus open repair of ruptured abdominal aortic aneurysm in the Amsterdam Acute Aneurysm Trial.

BACKGROUND: Minimally invasive endovascular aneurysm repair (EVAR) could be a surgical technique that improves outcome of patients with ruptured abdominal aortic aneurysm (rAAA). The aim of this study was to analyse the cost-effectiveness and cost-utility of EVAR compared with standard open repair (OR) in the treatment of rAAA, with costs per 30-day and 6-month survivor as outcome parameters. METHODS: Resource use was determined from the Amsterdam Acute Aneurysm (AJAX) trial, a multicentre randomized trial comparing EVAR with OR in patients with rAAA. The analysis was performed from a provider perspective. All costs were calculated as if all patients had been treated in the same hospital (Onze Lieve Vrouwe Gasthuis, teaching hospital). RESULTS: A total of 116 patients were randomized. The 30-day mortality rate was 21 per cent after EVAR and 25 per cent for OR: absolute risk reduction (ARR) 4·4 (95 per cent confidence interval (c.i.) -11·0 to 19·7) per cent. At 6 months, the total mortality rate for EVAR was 28 per cent, compared with 31 per cent among those assigned to OR: ARR 2·4 (-14·2 to 19·0) per cent. The mean cost difference between EVAR and OR was €5306 (95 per cent c.i. -1854 to 12,659) at 30 days and €10,189 (-2477 to 24,506) at 6 months. The incremental cost-effectiveness ratio per prevented death was €120,591 at 30 days and €424,542 at 6 months. There was no significant difference in quality of life between EVAR and OR. Nor was EVAR superior regarding cost-utility. CONCLUSION: EVAR may be more effective for rAAA, but its increased costs mean that it is unaffordable based on current standards of societal willingness-to-pay for health gains.

Systematic review of perioperative selective decontamination of the digestive tract in elective gastrointestinal surgery.

BACKGROUND: Studies on selective decontamination of the digestive tract (SDD) in elective gastrointestinal surgery have shown decreased rates of postoperative infection and anastomotic leakage. However, the prophylactic use of perioperative SDD in elective gastrointestinal surgery is not generally accepted. METHODS: A systematic review of randomized clinical trials (RCTs) was conducted to compare the effect of perioperative SDD with systemic antibiotics (SDD group) with systemic antibiotic prophylaxis alone (control group), using MEDLINE, Embase and the Cochrane Central Register of Controlled Trials. Endpoints included postoperative infection, anastomotic leakage, and in-hospital or 30-day mortality. RESULTS: Eight RCTs published between 1988 and 2011, with a total of 1668 patients (828 in the SDD group and 840 in the control group), were included in the meta-analysis. The total number of patients with infection (reported in 5 trials) was 77 (19.2 per cent) of 401 in the SDD group, compared with 118 (28.2 per cent) of 418 in the control group (odds ratio 0.58, 95 per cent confidence interval 0.42 to 0.82; P = 0.002). The incidence of anastomotic leakage was significantly lower in the SDD group: 19 (3.3 per cent) of 582 patients versus 44 (7.4 per cent) of 595 patients in the control group (odds ratio 0.42, 0.24 to 0.73; P = 0.002). CONCLUSION: This systematic review and meta-analysis suggests that a combination of perioperative SDD and perioperative intravenous antibiotics in elective gastrointestinal surgery reduces the rate of postoperative infection including anastomotic leakage compared with use of intravenous antibiotics alone.

Cost-effectiveness of perioperative selective decontamination of the digestive tract versus placebo in elective gastrointestinal surgery.

OBJECTIVE: We compared the routine use of perioperative selective decontamination of the digestive tract (SDD) for elective gastrointestinal surgery with placebo in a randomized controlled trial. Alongside this trial, a cost-effectiveness analysis from a provider perspective was performed. METHODS AND RESULTS: A total of 289 patients undergoing elective surgery of the digestive tract were randomized to either SDD (143 patients) or placebo (146 patients). Routine use of SDD led to less patients with an infectious complication compared with placebo (p = 0.028). Mean total costs per patient were slightly less (EUR 2,604; 95% CI -6,292 to 1,084) in patients randomized to SDD (EUR 12,031) compared to patients randomized to placebo (EUR 14,635). Costs of hospitalization were the main determinant of the cost difference between the groups. The incremental cost-effectiveness ratio per prevented occurrence of ≥1 infectious complications per patient was -EUR 23,164, indicating the superiority of SDD over placebo. CONCLUSION: This study shows that in patients undergoing elective gastrointestinal surgery, the routine use of SDD is less expensive and economically more efficient than placebo in reducing the number of patients with infectious complications.

Randomized clinical trial of perioperative selective decontamination of the digestive tract versus placebo in elective gastrointestinal surgery.

BACKGROUND: This randomized clinical trial analysed the effect of perioperative selective decontamination of the digestive tract (SDD) in elective gastrointestinal surgery on postoperative infectious complications and leakage. METHODS: All patients undergoing elective gastrointestinal surgery during a 5-year period were evaluated for inclusion. Randomized patients received either SDD (polymyxin B sulphate, tobramycin and amphotericin) or placebo in addition to standard antibiotic prophylaxis. The primary endpoint was postoperative infectious complications and anastomotic leakage during the hospital stay or 30 days after surgery. RESULTS: A total of 289 patients were randomized to either SDD (143) or placebo (146). Most patients (190, 65·7 per cent) underwent colonic surgery. There were 28 patients (19·6 per cent) with infectious complications in the SDD group compared with 45 (30·8 per cent) in the placebo group (P = 0·028). The incidence of anastomotic leakage in the SDD group was 6·3 per cent versus 15·1 per cent in the placebo group (P = 0·016). Hospital stay and mortality did not differ between groups. CONCLUSION: Perioperative SDD in elective gastrointestinal surgery combined with standard intravenous antibiotics reduced the rate of postoperative infectious complications and anastomotic leakage compared with standard intravenous antibiotics alone. Perioperative SD.D should be considered for patients undergoing gastrointestinal surgery. REGISTRATION NUMBER: P02.1187L (Dutch Central Committee on Research Involving Human Subjects).

Safety and outcome of general surgical open and laparoscopic procedures during pregnancy.

BACKGROUND: Surgical procedures during pregnancy carry the risk of adverse fetal outcome. We analyzed outcomes of open and laparoscopic approaches in patients treated for symptomatic cholelithiasis and suspected appendicitis. We reviewed the literature for evidence on the safety of both procedures. METHODS: We retrospectively reviewed the data of all patients who underwent surgery for symptomatic cholelithiasis and suspicion of appendicitis during pregnancy between January 2004 and March 2009. Fetal loss, preterm delivery, maternal outcome, and surgical complications were assessed. RESULTS: Twenty patients were operated on during pregnancy: 5 of 652 (0.8%) patients with symptomatic cholelithiasis and 15 (4.5%) of 331 for suspected appendicitis. All cholecystectomies were performed by laparoscopic procedure; no premature deliveries or fetal death occurred. In patients with suspicion of appendicitis, three appendices sana were diagnosed laparoscopically, and nine laparoscopic appendectomies and three open appendectomies were performed. The outcome was two preterm deliveries and one fetal death. CONCLUSION: Reviewing our results and the available literature, we believe that the outcome of surgery during pregnancy is not dictated by the type of procedure but by the type of disease. The gain for fetal outcome in the future most likely lies in the diagnostic pathway rather than the type of surgery.

Identification of risk factors for an unfavorable laparoscopic cholecystectomy course after endoscopic retrograde cholangiography in the treatment of choledocholithiasis.

BACKGROUND: Laparoscopic cholecystectomy (LC) after an endoscopic retrograde cholangiography (ERC) has higher rates for complications and conversion caused by unpredictable adhesions. The risk factors for an adverse outcome of LC after an ERC were analyzed. METHODS: Variables from patients treated by LC after ERC for cholelithiasis in two clinics from 1996 to 2003 were retrospectively stored in a database. Complications and conversions were recorded. RESULTS: A total of 140 patients underwent LC after ERC (83 from clinic A and 57 from clinic B), 31% (44/140) of whom were men. Peri- or postoperative complications occurred for 28 patients (20%). For 19 patients (14%), a conversion was necessary. Significant variables associated with complications and conversions were an elevated level of C-reactive protein (CRP) at the time of LC (odds ratio [OR], 10.2; 95% confidence interval [CI], 1.1-91, P = 0.037 for both) and severe adhesions during laparoscopy (OR, 3.6; 95% CI, 1.5-8.6; P = 0.003 and OR, 5.2; 95% CI, 1.9-14.4; P = 0.002, respectively). Male gender (OR, 2.8; 95% CI, 1.1-7.6; P = 0.037) and serum bilirubin level at the time of ERC (OR, 3.7; 95% CI, 1.24-11; P = 0.014) were associated with conversion only. Time after ERC (LC within 1 week vs. >1 week or < or = 2 weeks vs. 2-6 weeks vs. >6 weeks or < or = 6 weeks vs. >6 weeks) was not associated with complications or conversion. Multivariate regression analysis showed a pre-LC CRP exceeding 6 to be predictive of complications (OR, 10.5; 95% CI, 1.1-95; P = 0.040) and conversion (OR, 10.6; 95% CI, 1.1-99; P = 0.034). CONCLUSION: Male gender, bilirubin levels during ERC, severe adhesions during LC, and pre-LC CRP levels were associated with an adverse outcome for an LC after endoscopic cholangiography. The time between LC and ERC failed to be a significant risk factor in this larger series.

Cost-effectiveness of early versus selectively invasive strategy in patients with acute coronary syndromes without ST-segment elevation.

AIMS: The ICTUS trial compared an early invasive versus a selectively invasive strategy in high risk patients with a non-ST-segment elevation acute coronary syndrome and an elevated cardiac troponin T. Alongside the ICTUS trial a cost-effectiveness analysis from a provider perspective was performed. METHODS AND RESULTS: A total of 1200 patients with a non-ST-segment elevation acute coronary syndrome and an elevated cardiac troponin T were randomized. An early invasive strategy was not superior to a selectively strategy. Total costs per patient were 1379 euros (95% CI 416-2356) more expensive in the early invasive group (13,364 euros) than in the selectively invasive group (11,985 euros). Costs of revascularization were the main determinant of the cost difference between the two groups. The incremental cost-effectiveness ratio of the extra costs per prevented cardiac event was minus 89,477 euros. CONCLUSIONS: The overall results of the ICTUS study showed that an early invasive strategy was not superior to a selectively invasive strategy for patients with non-ST-segment elevation acute coronary syndrome and an elevated cardiac troponin T. This economic analysis of the ICTUS study showed that an early invasive strategy was slightly more expensive during the first year without gain in prevented cardiac events. In fact, we demonstrated a very moderate probability of the early invasive strategy being cost-efficient, even at a high level of willingness-to-pay.