Histology profiling of lung tumors: tru-cut versus full-core system for CT-guided biopsies.

PURPOSE: We aimed to compare the diagnostic yield and procedure-related complications of two different types of systems for percutaneous CT-guided lung biopsy. MATERIAL AND METHODS: All patients with a lung lesion who underwent a CT-guided lung biopsy at our institution, between January 2019 and 2021, were retrospectively analyzed. The inclusion criteria were: (a) Procedures performed using either a fully automated tru-cut or a semi-automated full-core biopsy needle, (b) CT images demonstrating the position of the needles within the lesion, (c) histopathological result of the biopsy and (d) clinical follow-up for at least 12 months and\or surgical histopathological results. A total of 400 biopsy fulfilling the inclusion criteria were selected and enrolled in the study. RESULTS: Overall technical success was 100% and diagnostic accuracy was 84%. Tru-cut needles showed a significantly higher diagnostic accuracy when compared to full-core needles (91% vs. 77%, p = 0.0004) and a lower rate of pneumothorax (31% vs. 41%, p = 0.047). Due to the statistically significant different of nodules size between the two groups, we reiterated the statistical analysis splitting our population around the 20 mm cut-off for nodule size. We still observed a significant difference in diagnostic accuracy between tru-cut and full-core needles favoring the former for both smaller and larger lesions (81% vs. 71%, p = 0.025; and 92% vs. 81%; p = 0.01, respectively). CONCLUSION: Our results demonstrated that the use of automated tru-cut needles is associated with higher histopathological diagnostic accuracy compared to semi-automated full-core needles for CTLB.

Lifestyle and incident dementia: A COSMIC individual participant data meta­analysis.

INTRODUCTION: The LIfestyle for BRAin Health (LIBRA) index yields a dementia risk score based on modifiable lifestyle factors and is validated in Western samples. We investigated whether the association between LIBRA scores and incident dementia is moderated by geographical location or sociodemographic characteristics. METHODS: We combined data from 21 prospective cohorts across six continents (N = 31,680) and conducted cohort-specific Cox proportional hazard regression analyses in a two-step individual participant data meta-analysis. RESULTS: A one-standard-deviation increase in LIBRA score was associated with a 21% higher risk for dementia. The association was stronger for Asian cohorts compared to European cohorts, and for individuals aged ≤75 years (vs older), though only within the first 5 years of follow-up. No interactions with sex, education, or socioeconomic position were observed. DISCUSSION: Modifiable risk and protective factors appear relevant for dementia risk reduction across diverse geographical and sociodemographic groups. HIGHLIGHTS: A two-step individual participant data meta-analysis was conducted. This was done at a global scale using data from 21 ethno-regionally diverse cohorts. The association between a modifiable dementia risk score and dementia was examined. The association was modified by geographical region and age at baseline. Yet, modifiable dementia risk and protective factors appear relevant in all investigated groups and regions.

Remote testing in Abbiategrasso (RTA): results from a counterbalanced cross-over study on direct-to-home neuropsychology with older adults.

BACKGROUND: The SARS-CoV-2 pandemic forced to rethink teleneuropsychology, since neuropsychological assessments started to be performed by phone or videoconference, with personal devices and without direct assistance from the clinician, a practice called "Direct-To-Home NeuroPsychology" (DTH-NP). AIMS: The present study, employing a counterbalanced cross-over design, was aimed at evaluating (1) the feasibility and (2) the acceptability of DTH-NP in Italian older adults without previously diagnosed neurocognitive disorder, (3) the comparability between remote and face-to-face administration of selected neuropsychological tests. METHODS: Fifty-eight community-dwelling older adults (65-85 years) were randomly assigned to one of two groups performing a complete neuropsychological assessment remotely (via phone call and videoconference) and face-to-face, in a counterbalance order, 8 weeks apart. The study recruitment rate was calculated, and the number of uncompleted tests and acceptability questionnaire responses were compared between the two administration modalities. Comparability was defined as good reliability of DTH-NP (intraclass correlation coefficient) and agreement between remote and face-to-face scores (Bland-Altman plots). RESULTS: Recruitment rate was 81%, with a preference for telephonic contact (79%). The acceptability analysis did not reveal any issues related to the DTH-NP assessment, even if most participants would rather repeat it face-to-face. Tests assessing short-term memory, language, and reasoning showed good comparability. DISCUSSION AND CONCLUSION: Our results point out to a good recruitment rate in a DTH-NP study in an Italian population of older adults (mean age = 80), satisfying acceptability of DTH-NP and remote-face-to-face comparability of certain verbally mediated tests. Further studies including larger samples in videoconference modality, and outpatients, could better clarify its strengths and limits.

Adherence to the Mediterranean diet and the impact on clinical features in primary Sjögren's syndrome.

OBJECTIVES: The relationship between dietary patterns, including the Mediterranean diet, and rheumatic and musculoskeletal diseases (RMDs) has been increasingly assessed but data on patients with established primary Sjögren's syndrome (pSS) is lacking. The aim of the study was to explore the adherence to the Mediterranean diet and its relationship with metabolic and inflammatory features in a cohort of patients with pSS. METHODS: Demographic, clinical and serological data, including anthropometric parameters and cardiovascular (CV) disease risk factors/events among others were collected from 91 pSS patients. Adherence to the Mediterranean diet over the previous 12 months was assessed with the 14-item PREvencion con DIeta MEDiterranea (PREDIMED) tool and the 28-item Mediterranean Lifestyle (MEDLIFE) index. RESULTS: According to the PREDIMED score 29 (31%) patients had a good adherence to the Mediterranean Diet, 57 (61%) a medium adherence and only 7 (8%) a poor adherence. No difference could be identified across groups with regard to demographic data, disease activity, CV risk factors or other parameters. With regard to the MEDLIFE, the total of blocks 1 and 2, that are related to Mediterranean foods and dietary habits, did not correlate with the total of block 3 (related to other healthy habits such as physical activity), meaning that the patients adhering the most to the Mediterranean Diet not necessarily had an overall healthy lifestyle. The PREDIMED score was inversely correlated with disease activity, as measured by ESSDAI (Spearman's rho=-0.27, p=0.009) and ClinESSDAI (Spearman's rho=-0.26, p=0.01). Fish consumption was associated with lower prevalence of hypertension. CONCLUSIONS: Adherence to the Mediterranean diet, with particular attention to fish consumption, may be beneficial on various domains in pSS, such as the CV system and the inflammatory environment, and as such should be recommended to patients with this disease.

Aspiration Thrombectomy with the Indigo System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome.

BACKGROUND: The purpose of our study is to assess the short-term technical success and the safety of the Indigo System in a series of patients undergoing vacuum-assisted catheter direct thrombus aspiration (IS-CDTA) for acute lower limb ischemia (ALLI) and to evaluate which parameters may affect the outcome. METHODS: All procedures using the IS-CDTA for ALLI, performed in a single-centre Interventional Radiology Unit from February 2016 to March 2020, were retrospectively analysed. Technical success was defined as the achievement of nearly-complete or complete revascularization (TIPI grade 2/3) and considered as a good outcome. Variables potentially correlated with the IS-CDTA outcome were analysed. RESULTS: 33 procedures were performed in 29 patients. Mean age was 69 years old (range 47 - 88), 24 males (83%) and 5 females (18%). The technical success was 70%. Catheter-directed thrombolysis following IS-CDTA was performed in 23 cases and the overall technical success increased from 70% to 90%, afterwards. The median time between symptoms insurgency and IS-CDTA was significantly shorter in patients with good outcome (10 hours; IQR 2.75-48) compared to those with poor outcome (168 hours; IQR 36-336) (P = 0.003). No statistically significant differences were found between the two groups regarding ATK vs. BTK (P = 0.34), native vessel vs. graft (P = 0.25), occlusion nature P = 0.28) or Rutherford score (P = 0.80). CONCLUSION: IS-CDTA is a valid option for a rapid and percutaneous treatment of ALLI. Our experience indicates that the time elapsing from the symptoms insurgency and the endovascular procedure is the best positive predictor of the outcome.

Double Valve Failure Due to Perceval Sutureless Aortic Valve Migration.

A 76-year-old woman was admitted to the authors' hospital with pulmonary edema five months after the successful implantation of a Perceval sutureless aortic valve (Sorin Group Srl, Saluggia, Italy). Both echocardiography and computed tomography scanning demonstrated migration of the aortic valve into the left ventricle, causing severe aortic and mitral (secondary) insufficiency. Following heart team discussions, the sutureless valve was replaced with a standard bioprosthesis (Perimount, Magna Ease; Edwards Lifesciences, Irvine, California, USA) with spontaneous restoration of native mitral valve competence. The present case is the first of a new presentation of early Perceval sutureless aortic valve proximal migration, and highlights the importance of careful preoperative assessment and regular postoperative follow up after sutureless aortic valve implantation.

Bedside Emergency Percutaneous Extracorporeal Membrane Oxygenator with Bicaval Dual-Lumen Cannula.

BACKGROUND: Veno-venous extracorporeal membrane oxygenation (VV-ECMO) support has emerged as a valuable rescue therapy in patients with severe acute lung failure. A new bicaval dual-lumen percutaneous cannula can be instituted with a single puncture of the right internal jugular vein under image guidance (fluoroscopy and/or trans-esophageal echocardiography) to support VV-ECMO. However, malpositioning of the dual-lumen catheter can jeopardize the efficacy of the ECMO therapy. CASE REPORT: We report an emergency VV-ECMO instituted at a patient's bedside in the intensive care unit. Percutaneous insertion of a dual lumen-cannula was performed on a young patient that had undergone cardiac surgery. The patient had developed a fulminant post-operative pneumonia, leading to respiratory failure and septic shock. The procedure was done at night, without any image guidance other than a post-insertion chest x-ray. We compared the oxygen saturation of arterial blood gas taken from both the outflow and inflow ECMO ends, and the saturations were used as indirect proof of correct cannula placement. The VV-ECMO was successfully removed after nine days, as the patient was clinically and radiologically recovered. CONCLUSION: This case reports a dual-lumen cannula insertion in an emergency setting, with minimal image support. It confirms the efficacy and the safety of VV-ECMO in the treatment of post-operative acute respiratory failure.

Endovascular treatment of visceral artery aneurysms and pseudoaneurysms with stent-graft: Analysis of immediate and long-term results. / Tratamiento endovascular de aneurismas y pseudoaneurismas de arterias viscerales mediante stenstents recubiertos: análisis de resultados inmediatos y a largo plazo.

INTRODUCTION: The aim of this study is to analyze the safety and efficacy of stent-graft endovascular treatment for visceral artery aneurysms and pseudoaneurysms. METHODS: Multicentric retrospective series of patients with visceral aneurysms and pseudoaneurysms treated by means of stent graft. The following variables were analyzed: Age, sex, type of lesion (aneurysms/pseudoaneurysms), localization, rate of success, intraprocedural and long term complication rate (SIR classification). Follow-up was performed under clinical and radiological assessment. RESULTS: Twenty-five patients (16 men), with a mean age of 59 (range 27-79), were treated. The indication was aneurysm in 19 patients and pseudoaneurysms in 6. The localizations were: splenic artery (12), hepatic artery (5), renal artery (4), celiac trunk (3) and gastroduodenal artery (1). Successful treatment rate was 96% (24/25 patients). Intraprocedural complication rate was 12% (4% major; 8% minor). Complete occlusion was demonstrated during follow up (mean 33 months, range 6-72) in the 24 patients with technical success. Two stent migrations (2/24; 8%) and 4stent thrombosis (4/24; 16%) were detected. Mortality rate was 0%. CONCLUSION: In our study, stent-graft endovascular treatment of visceral aneurysmns and pseudoaneurysms has demonstrated to be safe and is effective in the long-term in both elective and emergent cases, with a high rate of successful treatment and a low complication rate.

Endovascular management of massive post-partum haemorrhage in abnormal placental implantation deliveries.

OBJECTIVES: To retrospectively evaluate safety and efficacy of pelvic artery embolisation (PAE) in post-partum haemorrhage (PPH) in abnormal placental implantation (API) deliveries. METHODS: From January 2009 to November 2013, 12 patients with API and intractable intraoperative PPH underwent PAE after caesarean delivery to control a haemorrhage (in four of these cases after hysterectomy). Arterial access was obtained prior to the delivery; PAE was performed in the obstetrics operating room by an interventional radiologist that was present with an interventional radiology (IR) team during the delivery. RESULTS: PAE was successful in preventing bleeding and avoid hysterectomy in four cases (group A). Uterine atony and disseminated intravascular coagulation caused failure of PAE requiring hysterectomy in four patients (group B). PAE prevented bleeding post-hysterectomy in the remaining four cases (group C). Technical success (cessation of contrast extravasation on angiography or occlusion of the selected artery) was 100 %. Maternal and foetal mortality and morbidity were 0 %. CONCLUSIONS: PAE is a minimal invasive technique that may help to prevent hysterectomy and control PPH in API pregnancies without complications. Embolisation should be performed on an emergency basis. For such cases, an IR team on standby in the obstetrics theatre may be useful to prevent hysterectomy, blood loss and limit morbidity. KEY POINTS: • Endovascular treatment is a validated technique in post-partum haemorrhage. • Abnormal placental implantation is a risk factor for post-partum haemorrhage. • We propose an interventional radiologist standby in the delivery room.

Data Analytics for Smart Parking Applications.

We consider real-life smart parking systems where parking lot occupancy data are collected from field sensor devices and sent to backend servers for further processing and usage for applications. Our objective is to make these data useful to end users, such as parking managers, and, ultimately, to citizens. To this end, we concoct and validate an automated classification algorithm having two objectives: (1) outlier detection: to detect sensors with anomalous behavioral patterns, i.e., outliers; and (2) clustering: to group the parking sensors exhibiting similar patterns into distinct clusters. We first analyze the statistics of real parking data, obtaining suitable simulation models for parking traces. We then consider a simple classification algorithm based on the empirical complementary distribution function of occupancy times and show its limitations. Hence, we design a more sophisticated algorithm exploiting unsupervised learning techniques (self-organizing maps). These are tuned following a supervised approach using our trace generator and are compared against other clustering schemes, namely expectation maximization, k-means clustering and DBSCAN, considering six months of data from a real sensor deployment. Our approach is found to be superior in terms of classification accuracy, while also being capable of identifying all of the outliers in the dataset.

Clean Transformation of Ethanol to Useful Chemicals. The Behavior of a Gold-Modified Silicalite Catalyst.

Upon addition of gold to silicalite-1 pellets (a MFI-type zeolite), the vapor phase oxidation of ethanol could be addressed to acetaldehyde or acetic acid formation. By optimizing the catalyst composition and reaction conditions, the conversion of ethanol could be tuned to acetaldehyde with 97% selectivity at 71% conversion or to acetic acid with 78% selectivity at total conversion. Considering that unloaded silicalite-1 was found to catalyze the dehydration of ethanol to diethylether or ethene, a green approach for the integrated production of four important chemicals is herein presented. This is based on renewable ethanol as a reagent and a modular catalytic process.

The Clinical and Radiological Examination of Acute Intimate Partner Violence Injuries: A Retrospective Analysis of an Italian Cohort of Women.

BACKGROUND: Intimate partner violence (IPV) is the most frequent type of violence against women. We compared clinical and radiological IPV characteristics to stranger assault (SA). METHODS: We retrospectively identified 123 women with IPV from court reports and matched them to 124 SA. Clinical and radiological characteristics were evaluated by testing their sensitivity, specificity, positive and negative predictive value for IPV, and the strength of their association with IPV. RESULTS: IPV women referred with more delay to the emergency department (ED), had more ED accesses, and showed more mismatch between reports to the triage and disclosures to the ED physician. They also displayed more head, neck, and face injuries, and new-plus-old fractures. CONCLUSION: The identification of specific features may help ED physicians to suspect IPV.

Surgical Stress Reduction in Elderly Patients Undergoing Elective Colorectal Laparoscopic Surgery within an ERAS Protocol.

ERAS program applied to colorectal laparoscopic surgery is well known to reduce hospitalization improving short terms outcomes and minimizing the Surgical Stress Response. However its effectiveness in elderly population is yet to be demonstrated. The primary aim of this study is to compare the level of immune and nutritional serum indexes across surgery in patients aged over 70 years old undergoing elective colorectal laparoscopic surgery within an ERAS protocol or according to a Standard program. 83 patients undergoing colorectal laparoscopic surgery were enrolled and randomized in two groups (ERAS Group 40, Standard Group 43) within a larger randomized trial on a general population. Surgical stress parameters were collected preoperatively, 1, 3 and 5 days after surgery. Nutritional parameters were collected preoperatively, 1 and 5 days after surgery. Short Term Outcomes were also prospectively assessed. IL-6 levels were lower in the EG on 1, 3, and 5 days post-operatively (p 0.05). IL-6 levels in the Enhanced group returned to pre operative level 3 days after surgery. C-reactive protein level was lower in the Enhanced group on day 1, 3, and 5 (p 0.05). There was no difference in Cortisol and Prolactin levels between groups. Prealbumin serum level was higher on day 5 (p 0.05) compared to standard group. Postoperative outcomes in terms of normal bowel function and length of hospital stay were significantly improved in the ERAS group. Colorectal laparoscopic surgery within an ERAS prototcol in elderly patients affects Surgical Stress Response, decreasing IL-6 and CRP levels postoperatively and improving Prealbumin post operative synthesis.

Platelet-rich plasma inside the sternotomy wound reduces the incidence of sternal wound infections.

Despite the large choice of wide-spectrum antibiotic therapy, deep sternal wound infection (DSWI) following cardiac surgery is a life-threatening complication worldwide. This study evaluated that the use of platelet-rich plasma (PRP) applied inside the sternotomy wound would reduce the effect of sternal wound infections, both superficial and deep. Between January 2007 and January 2012, 1093 consecutive patients underwent cardiac surgery through median sternotomy. Patients were divided into two groups. Group B, the study group, included those who received the PRP applied inside the sternotomy wound before closure. Group A, the control group, included patients who received a median sternotomy but without the application of PRP. Antibiotic prophylaxis remained unchanged across the study and between the two groups. Occurrence of DSWI was significantly higher in group A than in group B [10 of 671 (1·5%) versus 1 of 422 (0·20%), P = 0·043]. Also, superficial sternal wound infections (SSWIs) were significantly higher in group A than in group B [19 of 671 (2·8%) versus 2 of 422 (0·5%), P = 0·006]. The use of PRP can significantly reduce the occurrence of DSWI and SSWI in cardiac surgery.

Embolization of the periprostatic venous plexus for erectile dysfunction resulting from venous leakage.

PURPOSE: To evaluate retrospectively the safety and efficacy of anterograde embolization of the periprostatic venous plexus (AEPV) via percutaneous access of the deep dorsal vein of the penis for erectile dysfunction (ED) resulting from veno-occlusive dysfunction (VOD). MATERIALS AND METHODS: From September 2009 through December 2012, 18 patients with moderate to severe ED secondary to insufficiency of physiologic venous occlusion as diagnosed by color Doppler evaluation of the penis after direct pharmacologic stimulation were treated. Preliminary diagnoses were also confirmed with dynamic cavernosography. Selective AEPV was achieved using a combination of N-butyl cyanoacrylate and endovascular coils. Follow-up consisted of collecting International Index of Erectile Function questionnaire (IIEF-6) scores and repeated color Doppler evaluation. RESULTS: Immediate technical success was achieved in 16 of 18 patients (88.8%). Follow-up data were obtained at a mean of 13.3 months ± 7.5. In 12 of the patients with technical success, the mean IIEF-6 score improved from 10.5 ± 5.2 to 20.6 ± 8.4 after the procedure (P = .0069). At 3-month short-term follow-up, clinical success defined by an end-diastolic velocity of < 5 cm/s on color Doppler was noted in 81% (13 of 16 patients). Of these 13 patients, 7 patients had continued erectile function at the end of follow-up, and the other 6 patients reported progressive diminishment in the benefit over time. No major complications and two minor complications were encountered. CONCLUSIONS: AEPV for ED secondary to VOD is a safe alternative to surgical treatment that demonstrates promising short-term and midterm efficacy.

Fewer-than-four ports versus four ports for laparoscopic cholecystectomy.

BACKGROUND: Traditionally, laparoscopic cholecystectomy is performed using two 10-mm ports and two 5-mm ports. Recently, a reduction in the number of ports has been suggested as a modification of the standard technique with a view to decreasing pain and improving cosmesis. The safety and effectiveness of using fewer-than-four ports has not yet been established. OBJECTIVES: To assess the benefits (such as improvement in cosmesis and earlier return to activity) and harms (such as increased complications) of using fewer-than-four ports (fewer-than-four-ports laparoscopic cholecystectomy) versus four ports in people undergoing laparoscopic cholecystectomy for any reason (symptomatic gallstones, acalculous cholecystitis, gallbladder polyp, or any other condition). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2013), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization International Clinical Trials Registry Platform portal to September 2013. SELECTION CRITERIA: We included all randomised clinical trials comparing fewer-than-four ports versus four ports, that is, with standard laparoscopic cholecystectomy that is performed with two ports of at least 10-mm incision and two ports of at least 5-mm incision. DATA COLLECTION AND ANALYSIS: Two review authors independently identified the trials and extracted the data. We analysed the data using both the fixed-effect and the random-effects models. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis, whenever possible. MAIN RESULTS: We found nine trials with 855 participants that randomised participants to fewer-than-four-ports laparoscopic cholecystectomy (n = 427) versus four-port laparoscopic cholecystectomy (n = 428). Most trials included low anaesthetic risk participants undergoing elective laparoscopic cholecystectomy. Seven of the nine trials used a single port laparoscopic cholecystectomy and the remaining two trials used three-port laparoscopic cholecystectomy as the experimental intervention. Only one trial including 70 participants had low risk of bias. Fewer-than-four-ports laparoscopic cholecystectomy could be completed successfully in more than 90% of participants in most trials. The remaining participants were mostly converted to four-port laparoscopic cholecystectomy but some participants had to undergo open cholecystectomy.There was no mortality in either group in the seven trials that reported mortality (318 participants in fewer-than-four-ports laparoscopic cholecystectomy group and 316 participants in four-port laparoscopic cholecystectomy group). The proportion of participants with serious adverse events was low in both treatment groups and the estimated RR was compatible with a reduction and substantial increased risk with the fewer-than-four-ports group (6/318 (1.9%)) and four-port laparoscopic cholecystectomy group (0/316 (0%)) (RR 3.93; 95% CI 0.86 to 18.04; 7 trials; 634 participants; very low quality evidence). The estimated difference in the quality of life (measured between 10 and 30 days) was imprecise (standardised mean difference (SMD) 0.18; 95% CI -0.05 to 0.42; 4 trials; 510 participants; very low quality evidence), as was the proportion of participants in whom the laparoscopic cholecystectomy had to be converted to open cholecystectomy between the groups (fewer-than-four ports 3/289 (adjusted proportion 1.2%) versus four port: 5/292 (1.7%); RR 0.68; 95% CI 0.19 to 2.35; 5 trials; 581 participants; very low quality evidence). The fewer-than-four-ports laparoscopic cholecystectomy took 14 minutes longer to complete (MD 14.44 minutes; 95% CI 5.95 to 22.93; 9 trials; 855 participants; very low quality evidence). There was no clear difference in hospital stay between the groups (MD -0.01 days; 95% CI -0.28 to 0.26; 6 trials; 731 participants) or in the proportion of participants discharged as day surgery (RR 0.92; 95% CI 0.70 to 1.22; 1 trial; 50 participants; very low quality evidence) between the two groups. The times taken to return to normal activity and work were shorter by two days in the fewer-than-four-ports group compared with four-port laparoscopic cholecystectomy (return to normal activity: MD -1.20 days; 95% CI -1.58 to -0.81; 2 trials; 325 participants; very low quality evidence; return to work: MD -2.00 days; 95% CI -3.31 to -0.69; 1 trial; 150 participants; very low quality evidence). There was no significant difference in cosmesis scores at 6 to 12 months between the two groups (SMD 0.37; 95% CI -0.10 to 0.84; 2 trials; 317 participants; very low quality evidence). AUTHORS' CONCLUSIONS: There is very low quality evidence that is insufficient to determine whether there is any significant clinical benefit in using fewer-than-four-ports laparoscopic cholecystectomy compared with four-port laparoscopic cholecystectomy. The safety profile of using fewer-than-four ports is yet to be established and fewer-than-four-ports laparoscopic cholecystectomy should be reserved for well-designed randomised clinical trials.

Wound infiltration with local anaesthetic agents for laparoscopic cholecystectomy.

BACKGROUND: While laparoscopic cholecystectomy is generally considered to be less painful than open surgery, pain is one of the important reasons for delayed discharge after day surgery resulting in overnight stay following laparoscopic cholecystectomy. The safety and effectiveness of local anaesthetic wound infiltration in people undergoing laparoscopic cholecystectomy is not known. OBJECTIVES: To assess the benefits and harms of local anaesthetic wound infiltration in patients undergoing laparoscopic cholecystectomy and to identify the best method of local anaesthetic wound infiltration with regards to the type of local anaesthetic, dosage, and time of administration of the local anaesthetic. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013 to identify studies of relevance to this review. We included randomised clinical trials for benefit and quasi-randomised and comparative non-randomised studies for treatment-related harms. SELECTION CRITERIA: Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing local anaesthetic wound infiltration versus placebo, no intervention, or inactive control during laparoscopic cholecystectomy, trials comparing different local anaesthetic agents for local anaesthetic wound infiltration, and trials comparing the different times of local anaesthetic wound infiltration were considered for the review. DATA COLLECTION AND ANALYSIS: Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects meta-analysis models using RevMan. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence interval (CI). MAIN RESULTS: Twenty-six trials fulfilled the inclusion criteria of the review. All the 26 trials except one trial of 30 participants were at high risk of bias. Nineteen of the trials with 1263 randomised participants provided data for this review. Ten of the 19 trials compared local anaesthetic wound infiltration versus inactive control. One of the 19 trials compared local anaesthetic wound infiltration with two inactive controls, normal saline and no intervention. Two of the 19 trials had four arms comparing local anaesthetic wound infiltration with inactive controls in the presence and absence of co-interventions to decrease pain after laparoscopic cholecystectomy. Four of the 19 trials had three or more arms that could be included for the comparison of local anaesthetic wound infiltration versus inactive control and different methods of local anaesthetic wound infiltration. The remaining two trials compared different methods of local anaesthetic wound infiltration.Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Seventeen trials randomised a total of 1095 participants to local anaesthetic wound infiltration (587 participants) versus no local anaesthetic wound infiltration (508 participants). Various anaesthetic agents were used but bupivacaine was the commonest local anaesthetic used. There was no mortality in either group in the seven trials that reported mortality (0/280 (0%) in local anaesthetic infiltration group versus 0/259 (0%) in control group). The effect of local anaesthetic on the proportion of people who developed serious adverse events was imprecise and compatible with increase or no difference in serious adverse events (seven trials; 539 participants; 2/280 (0.8%) in local anaesthetic group versus 1/259 (0.4%) in control; RR 2.00; 95% CI 0.19 to 21.59; very low quality evidence). None of the serious adverse events were related to local anaesthetic wound infiltration. None of the trials reported patient quality of life. The proportion of participants who were discharged as day surgery patients was higher in the local anaesthetic infiltration group than in the no local anaesthetic infiltration group (one trial; 97 participants; 33/50 (66.0%) in the local anaesthetic group versus 20/47 (42.6%) in the control group; RR 1.55; 95% CI 1.05 to 2.28; very low quality evidence). The effect of local anaesthetic on the length of hospital stay was compatible with a decrease, increase, or no difference in the length of hospital stay between the two groups (four trials; 327 participants; MD -0.26 days; 95% CI -0.67 to 0.16; very low quality evidence). The pain scores as measured by the visual analogue scale (0 to 10 cm) were lower in the local anaesthetic infiltration group than the control group at 4 to 8 hours (13 trials; 806 participants; MD -1.33 cm on the VAS; 95% CI -1.54 to -1.12; very low quality evidence) and 9 to 24 hours (12 trials; 756 participants; MD -0.36 cm on the VAS; 95% CI -0.53 to -0.20; very low quality evidence). The effect of local anaesthetic on the time taken to return to normal activity between the two groups was imprecise and compatible with a decrease, increase, or no difference in the time taken to return to normal activity (two trials; 195 participants; MD 0.14 days; 95% CI -0.59 to 0.87; very low quality evidence). None of the trials reported on return to work.Four trials randomised a total of 149 participants to local anaesthetic wound infiltration prior to skin incision (74 participants) versus local anaesthetic wound infiltration at the end of surgery (75 participants). Two trials randomised a total of 176 participants to four different local anaesthetics (bupivacaine, levobupivacaine, ropivacaine, neosaxitoxin). Although there were differences between the groups in some outcomes the changes were not consistent. There was no evidence to support the preference of one local anaesthetic over another or to prefer administration of local anaesthetic at a specific time compared with another. AUTHORS' CONCLUSIONS: Serious adverse events were rare in studies evaluating local anaesthetic wound infiltration (very low quality evidence). There is very low quality evidence that infiltration reduces pain in low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. However, the clinical importance of this reduction in pain is likely to be small. Further randomised clinical trials at low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.