Search

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of biliary anastomosis, with or without the use of T‐tube in adults undergoing liver transplantation.

Background A number of conditions compromise the passage of food along the digestive tract. Nasogastric tube (NGT) feeding is a classic, time-proven technique, although its prolonged use can lead to complications such as lesions to the nasal wing, chronic sinusitis, gastro-oesophageal reflux, and aspiration pneumonia. Another method of infusion, percutaneous endoscopy gastrostomy (PEG), is generally used when there is a need for enteral nutrition for a longer time period. There is a high demand for PEG in patients with swallowing disorders, although there is no consistent evidence about its effectiveness and safety as compared to NGT. Objectives To evaluate the effectiveness and safety of PEG compared with NGT for adults with swallowing disturbances. Search methods We searched The Cochrane Library, MEDLINE, EMBASE, and LILACS from inception to January 2014, and contacted the main authors in the subject area. There was no language restriction in the search. Selection criteria We planned to include randomised controlled trials comparing PEG versus NGT for adults with swallowing disturbances or dysphagia and indications for nutritional support, with any underlying diseases. The primary outcome was intervention failure (e.g. feeding interruption, blocking or leakage of the tube, no adherence to treatment). Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. For dichotomous and continuous variables, we used risk ratio (RR) and mean difference (MD), respectively with the random-effects statistical model and 95% confidence interval (CI). We assumed statistical heterogeneity when I² > 50%. Main results We included 11 randomised controlled studies with 735 participants which produced 16 meta-analyses of outcome data. Meta-analysis indicated that the primary outcome of intervention failure, occurred in lower proportion of participants with PEG compared to NGT (RR 0.18, 95% CI 0.05 to 0.59, eight studies, 408 participants, low quality evidence) and this difference was statistically significant. For this outcome, we also subgrouped the studies by endoscopic gastrostomy technique into pull, and push and not reported. We observed a significant difference favouring PEG in the pull subgroup (RR 0.07, 95% CI 0.01 to 0.35, three studies, 90 participants). Thepush subgroup contained only one clinical trial and the result favoured PEG (RR 0.05, 95% CI 0.00 to 0.74, one study, 33 participants) techniques. We found no statistically significant difference in cases where the technique was not reported (RR 0.43, 95% CI 0.13 to 1.44, four studies, 285 participants). There was no statistically significant difference between the groups for meta-analyses of the secondary outcomes of mortality (RR 0.86, 95% CI 0.58 to 1.28, 644 participants, nine studies, very low quality evidence), overall reports of any adverse event at any follow-up time point (ITT analysis, RR 0.83, 95% CI 0.51 to 1.34), 597 participants, 6 studies, moderate quality evidence), specific adverse events including pneumonia (aspiration) (RR 0.70, 95% CI 0.46 to 1.06, 645 participants, seven studies, low quality evidence), or for the meta- analyses of the secondary outcome of nutritional status including weight change from baseline, and mid-arm circumference at endpoint, although there was evidence in favour of PEG for meta-analyses of mid-arm circumference change from baseline (MD 1.16, 95% CI 1.01 to 1.31, 115 participants, two studies), and levels of serum albumin were higher in the PEG group (MD 6.03, 95% CI 2.31 to 9.74, 107 participants). For meta-analyses of the secondary outcomes of time on enteral nutrition, there was no statistically significant difference (MD 14.48, 95% CI -2.74 to 31.71; 119 participants, two studies). For meta-analyses of quality of life measures (EuroQol) outcomes in two studies with 133 participants, for inconvenience (RR 0.03, 95% CI 0.00 to 0.29), discomfort (RR 0.03, 95% CI 0.00 to 0.29), altered body image (RR 0.01, 95% CI 0.00 to 0.18; P = 0.001) and social activities (RR 0.01, 95% CI 0.00 to 0.18) the intervention favoured PEG, that is, fewer participants found the intervention of PEG to be inconvenient, uncomfortable or interfered with social activities. However, there were no significant differences between the groups for pain, ease of learning to use, or the secondary outcome of length of hospital stay (two studies, 381 participants). Authors' conclusions PEG was associated with a lower probability of intervention failure, suggesting the endoscopic procedure may be more effective and safe compared with NGT. There is no significant difference in mortality rates between comparison groups, or in adverse events, including pneumonia related to aspiration. Future studies should include details of participant demographics including underlying disease, age and gender, and the gastrostomy technique.

Background For more than a century the presence of bowel content during surgery has been related to anastomotic leakage. Mechanical bowel preparation has been considered an efficient agent against leakage and infections complications. This dogma is not based on solid evidence, but more on observational data and expert´s opinions. Objectives To determine the security and effectiveness of prophylactic mechanical bowel preparation for morbidity and mortality rates in colorectal surgery. The following hypothesis was tested: "The use of mechanical bowel preparation before elective colorectal surgery reduces the incidence of postoperative complications". Search strategy All publications describing mechanical bowel preparation before elective colorectal surgery was sought through computerized searches of EMBASE, LILACS, MEDLINE, and Cochrane Library; by hand-searching in relevant medical journals, from major gastroenterological congresses, without limitation for date and language, using the search strategy described by the Colorectal Cancer Review Group. In addition, randomised clinical trials will be searched through personal communication with colleagues and from conference proceedings Selection criteria STUDIES: All randomised, clinical trials, that were performed in order to answer the hypothesis. PARTICIPANTS: Patients submitted elective colorectal surgery. INTERVENTIONS: Any strategy in mechanical bowel preparation compared with no mechanical bowel preparation. PRIMARY OUTCOME MEASURES: 1. Anastomosis leakage- stratified for rectum and colon 2. Overall anastomotic leakage SECONDARY OUTCOME MEASURES: 3. Mortality 4. Peritonitis 5. Re operation 6. Wound Infection 7 Infectious extra-abdominal complication 8. Non-infection extra-abdominal 9. Overall surgical site infections Data collection and analysis Data was independently extracted by two reviewers and cross-checked. The methodological quality of each trial was assessed by the same two reviewers. Details of the randomisation (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up was recorded. The results of each RCT was summarised in 2 x 2 tables for each outcome. For analysis the Peto-Odds ratio was used as defaults (no statistical heterogeneity was observed) Main results Of the 1159 patients with anastomosis (6 RCTs), 576 were allocated for mechanical bowel preparation (groups 1) and 583 for no preparation (groups 2) before elective colorectal surgery. Of 1204 patients totally enrolled 595 were in groups 1 and 609 in groups 2. PRIMARY OUTCOMES: 1) Anastomotic leakage - stratified:A) Low anterior resection: 12.5% (6 of 48 patients in 1) compared with 12% (6 of 50 patients in 2); Peto OR 1.17, 95% CI: 0.35 - 3.96 (non-significant) B) Colonic surgery: 1.16% (2 of 172 patients in 1) compared with 0.6% (1 of 166 patients in 2) ; Peto OR 1.75, 95% CI: 0.18 - 17.02 2) Overall anastomotic leakage: 5.5% (32 of 576 patients in 1) compared with 2.9% (17 of 583 patients in 2); Peto OR 1.94, 95% CI: 1.09 - 3.43 (P=0.02) SECONDARY OUTCOMES: 3) Mortality: 0.6% (2 of 329 patients in 1) compared with 0% (0 of 326 patients in 2); Peto OR 7.95, 95% CI: 0.49 - 128.34 (non-significant) 4) Peritonitis: 5.1% ( 13 of 254 patients in 1) compared with 2.8% (7 of 252 patients in 2); Peto OR 1.90, 95% CI: 0.78 -4.64) (non significant) 5) Reoperation: 3.3% ( 11 of 329 patients) compared with 2.5% (8 of 326 patients); Peto OR 1.40, 95% CI: 0.56 - 3.49) (non-significant) 6) Wound infection: 7.4% (44 of 595 patients in 1) compared with 5.7% (35 of 609 patients in 2); Peto OR 1.34, 95% CI: 0.85 - 2.13 (non-significant) 7) Infectious extra-abdominal complication: 8.3% ( 14 of 168 patients in 1) compared with 9.4% (15 of 159 patients in 2); Peto OR, 95%: 0.87 (0.41 - 1.87) 8) Non-infection extra-abdominal complication: 8.0% ( 20 of 250 patients in 1) compared with 7.0% (17 of 246 patients in 2); Peto OR 1.19, 95% CI: 0.61 - 2.32 (non-significant) - 9) Surgical site infection: 9.8% (31 of 325 patients in 1) compared with 8.3% (27 of 322 patients in 2); Peto OR 1.20, 95% CI: 0.70 - 2.05 (non-significant) - Reviewers' conclusions The results failed to support the hypothesis that bowel preparation reduces anastomotic leak rates and other complications. There was no a priori hypothesis that bowel preparation may increase anastomotic leak rates, so this was not stated. Thus, the routine use of mechanical bowel preparation in patients undergoing elective colorectal surgery is questioned.