Early versus delayed dressing removal after primary closure of clean and clean-contaminated surgical wounds.

BACKGROUND: Most surgical procedures involve a cut in the skin that allows the surgeon to gain access to the deeper tissues or organs. Most surgical wounds are closed fully at the end of the procedure (primary closure). The surgeon covers the closed surgical wound with either a dressing or adhesive tape. The dressing can act as a physical barrier to protect the wound until the continuity of the skin is restored (within about 48 hours) and to absorb exudate from the wound, keeping it dry and clean, and preventing bacterial contamination from the external environment. Some studies have found that the moist environment created by some dressings accelerates wound healing, although others believe that the moist environment can be a disadvantage, as excessive exudate can cause maceration (softening and deterioration) of the wound and the surrounding healthy tissue. The utility of dressing surgical wounds beyond 48 hours of surgery is, therefore, controversial. OBJECTIVES: To evaluate the benefits and risks of removing a dressing covering a closed surgical incision site within 48 hours permanently (early dressing removal) or beyond 48 hours of surgery permanently with interim dressing changes allowed (delayed dressing removal), on surgical site infection. SEARCH METHODS: In March 2015 we searched the following electronic databases: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. We also searched the references of included trials to identify further potentially-relevant trials. SELECTION CRITERIA: Two review authors independently identified studies for inclusion. We included all randomised clinical trials (RCTs) conducted with people of any age and sex, undergoing a surgical procedure, who had their wound closed and a dressing applied. We included only trials that compared early versus delayed dressing removal. We excluded trials that included people with contaminated or dirty wounds. We also excluded quasi-randomised studies, and other study designs. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data on the characteristics of the trial participants, risk of bias in the trials and outcomes for each trial. We calculated risk ratios (RR) with 95% confidence intervals (CI) for binary outcomes and mean difference (MD) with 95% CI for continuous outcomes. We used RevMan 5 software to perform these calculations. MAIN RESULTS: Four trials were identified for inclusion in this review. All the trials were at high risk of bias. Three trials provided information for this review. Overall, this review included 280 people undergoing planned surgery. Participants were randomised to early dressing removal (removal of the wound dressing within the 48 hours following surgery) (n = 140) or delayed dressing removal (continued dressing of the wound beyond 48 hours) (n = 140) in the three trials. There were no statistically significant differences between the early dressing removal group and delayed dressing removal group in the proportion of people who developed superficial surgical site infection within 30 days (RR 0.64; 95% CI 0.32 to 1.28), superficial wound dehiscence within 30 days (RR 2.00; 95% CI 0.19 to 21.16) or serious adverse events within 30 days (RR 0.83; 95% CI 0.28 to 2.51). No deep wound infection or deep wound dehiscence occurred in any of the participants in the trials that reported this outcome. None of the trials reported quality of life. The hospital stay was significantly shorter (MD -2.00 days; 95% CI -2.82 to -1.18) and the total cost of treatment significantly less (MD EUR -36.00; 95% CI -59.81 to -12.19) in the early dressing removal group than in the delayed dressing removal group in the only trial that reported these outcomes. AUTHORS' CONCLUSIONS: The early removal of dressings from clean or clean contaminated surgical wounds appears to have no detrimental effect on outcomes. However, it should be noted that the point estimate supporting this statement is based on very low quality evidence from three small randomised controlled trials, and the confidence intervals around this estimate were wide. Early dressing removal may result in a significantly shorter hospital stay, and significantly reduced costs, than covering the surgical wound with wound dressings beyond the first 48 hours after surgery, according to very low quality evidence from one small randomised controlled trial. Further randomised controlled trials of low risk of bias are necessary to investigate whether dressings are necessary after 48 hours in different types of surgery and levels of contamination and investigate whether antibiotic therapy influences the outcome.

Evaluation of PIK3CA mutation as a predictor of benefit from nonsteroidal anti-inflammatory drug therapy in colorectal cancer.

PURPOSE: Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) protect against colorectal cancer (CRC) and are associated with reduced disease recurrence and improved outcome after primary treatment. However, toxicities of NSAIDs have limited their use as antineoplastic therapy. Recent data have suggested that the benefit of aspirin after CRC diagnosis is limited to patients with PIK3CA-mutant cancers. We sought to determine the predictive utility of PIK3CA mutation for benefit from both cyclooxygenase-2 inhibition and aspirin. METHODS: We performed molecular analysis of tumors from 896 participants in the Vioxx in Colorectal Cancer Therapy: Definition of Optimal Regime (VICTOR) trial, a large randomized trial comparing rofecoxib with placebo after primary CRC resection. We compared relapse-free survival and overall survival between rofecoxib therapy and placebo and between the use and nonuse of low-dose aspirin, according to tumor PIK3CA mutation status. RESULTS: We found no evidence of a greater benefit from rofecoxib treatment compared with placebo in patients whose tumors had PIK3CA mutations (multivariate adjusted hazard ratio [HR], 1.2; 95% CI, 0.53 to 2.72; P = .66; (P)INTERACTION = .47) compared with patients with PIK3CA wild-type cancers (HR, 0.87; 95% CI, 0.64 to 1.16; P = .34). In contrast, regular aspirin use after CRC diagnosis was associated with a reduced rate of CRC recurrence in patients with PIK3CA-mutant cancers (HR, 0.11; 95% CI, 0.001 to 0.832; P = .027; (P)INTERACTION = .024) but not in patients lacking tumor PIK3CA mutation (HR, 0.92; 95% CI, 0.60 to 1.42; P = .71). CONCLUSION: Although tumor PIK3CA mutation does not predict benefit from rofecoxib treatment, it merits further evaluation as a predictive biomarker for aspirin therapy. Our findings are concordant with recent data and support the prospective investigation of adjuvant aspirin in PIK3CA-mutant CRC.

Early versus delayed dressing removal after primary closure of clean and clean-contaminated surgical wounds.

BACKGROUND: Most surgical procedures involve a cut in the skin that allows the surgeon to gain access to the deeper tissues or organs. Most surgical wounds are closed fully at the end of the procedure (primary closure). The surgeon covers the closed surgical wound with either a dressing or adhesive tape. The dressing can act as a physical barrier to protect the wound until the continuity of the skin is restored (within about 48 hours) and to absorb exudate from the wound, keeping it dry and clean, and preventing bacterial contamination from the external environment. Some studies have found that the moist environment created by some dressings accelerates wound healing, although others believe that the moist environment can be a disadvantage, as excessive exudate can cause maceration (softening and deterioration) of the wound and the surrounding healthy tissue. The utility of dressing surgical wounds beyond 48 hours of surgery is, therefore, controversial. OBJECTIVES: To evaluate the benefits and risks of removing a dressing covering a closed surgical incision site within 48 hours permanently (early dressing removal) or beyond 48 hours of surgery permanently with interim dressing changes allowed (delayed dressing removal), on surgical site infection. SEARCH METHODS: In July 2013 we searched the following electronic databases: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. We also searched the references of included trials to identify further potentially-relevant trials. SELECTION CRITERIA: Two review authors independently identified studies for inclusion. We included all randomised clinical trials (RCTs) conducted with people of any age and sex, undergoing a surgical procedure, who had their wound closed and a dressing applied. We included only trials that compared early versus delayed dressing removal. We excluded trials that included people with contaminated or dirty wounds. We also excluded quasi-randomised studies, and other study designs. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data on the characteristics of the trial participants, risk of bias in the trials and outcomes for each trial. We calculated risk ratios (RR) with 95% confidence intervals (CI) for binary outcomes and mean difference (MD) with 95% CI for continuous outcomes. We used RevMan 5 software to perform these calculations. MAIN RESULTS: Four trials were identified for inclusion in this review. All the trials were at high risk of bias. Three trials provided information for this review. Overall, this review included 280 people undergoing planned surgery. Participants were randomised to early dressing removal (removal of the wound dressing within the 48 hours following surgery) (n = 140) or delayed dressing removal (continued dressing of the wound beyond 48 hours) (n = 140) in the three trials. There were no statistically significant differences between the early dressing removal group and delayed dressing removal group in the proportion of people who developed superficial surgical site infection within 30 days (RR 0.64; 95% CI 0.32 to 1.28), superficial wound dehiscence within 30 days (RR 2.00; 95% CI 0.19 to 21.16) or serious adverse events within 30 days (RR 0.83; 95% CI 0.28 to 2.51). No deep wound infection or deep wound dehiscence occurred in any of the participants in the trials that reported this outcome. None of the trials reported quality of life. The hospital stay was significantly shorter (MD -2.00 days; 95% CI -2.82 to -1.18) and the total cost of treatment significantly less (MD EUR -36.00; 95% CI -59.81 to -12.19) in the early dressing removal group than in the delayed dressing removal group in the only trial that reported these outcomes. AUTHORS' CONCLUSIONS: The early removal of dressings from clean or clean contaminated surgical wounds appears to have no detrimental effect on outcomes. However, it should be noted that the point estimate supporting this statement is based on very low quality evidence from three small randomised controlled trials, and the confidence intervals around this estimate were wide. Early dressing removal may result in a significantly shorter hospital stay, and significantly reduced costs, than covering the surgical wound with wound dressings beyond the first 48 hours after surgery, according to very low quality evidence from one small randomised controlled trial. Further randomised controlled trials of low risk of bias are necessary to investigate whether dressings are necessary after 48 hours in different types of surgery and levels of contamination and investigate whether antibiotic therapy influences the outcome.

Miniports versus standard ports for laparoscopic cholecystectomy.

BACKGROUND: In conventional (standard) port laparoscopic cholecystectomy, four abdominal ports (two of 10 mm diameter and two of 5 mm diameter) are used. Recently, use of smaller ports, miniports, have been reported. OBJECTIVES: To assess the benefits and harms of miniport (defined as ports smaller than the standard ports) laparoscopic cholecystectomy versus standard port 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 to identify randomised clinical trials of relevance to this review. SELECTION CRITERIA: Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing miniport versus standard port laparoscopic cholecystectomy 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 models using RevMan analysis. For each outcome we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI). MAIN RESULTS: We included 12 trials with 734 patients randomised to miniport laparoscopic cholecystectomy (380 patients) versus standard laparoscopic cholecystectomy (351 patients). Only one trial which included 70 patients was of low risk of bias. Miniport laparoscopic cholecystectomy could be completed successfully in more than 80% of patients in most trials. The remaining patients were mostly converted to standard port laparoscopic cholecystectomy but some were also converted to open cholecystectomy. These patients were included for the outcome conversion to open cholecystectomy but excluded from other outcomes. Accordingly, the results of the other outcomes are on 343 patients in the miniport laparoscopic cholecystectomy group and 351 patients in the standard port laparoscopic cholecystectomy group, and therefore the results have to be interpreted with extreme caution.There was no mortality in the seven trials that reported mortality (0/194 patients in miniport laparoscopic cholecystectomy versus 0/203 patients in standard port laparoscopic cholecystectomy). There were no significant differences between miniport laparoscopic cholecystectomy and standard laparoscopic cholecystectomy in the proportion of patients who developed serious adverse events (eight trials; 460 patients; RR 0.33; 95% CI 0.04 to 3.08) (miniport laparoscopic cholecystectomy: 1/226 (adjusted proportion 0.4%) versus standard laparoscopic cholecystectomy: 3/234 (1.3%); quality of life at 10 days after surgery (one trial; 70 patients; SMD -0.20; 95% CI -0.68 to 0.27); or in whom the laparoscopic operation had to be converted to open cholecystectomy (11 trials; 670 patients; RR 1.23; 95% CI 0.44 to 3.45) (miniport laparoscopic cholecystectomy: 8/351 (adjusted proportion 2.3%) versus standard laparoscopic cholecystectomy 6/319 (1.9%)). Miniport laparoscopic cholecystectomy took five minutes longer to complete than standard laparoscopic cholecystectomy (12 trials; 695 patients; MD 4.91 minutes; 95% CI 2.38 to 7.44). There were no significant differences between miniport laparoscopic cholecystectomy and standard laparoscopic cholecystectomy in the length of hospital stay (six trials; 351 patients; MD -0.00 days; 95% CI -0.12 to 0.11); the time taken to return to activity (one trial; 52 patients; MD 0.00 days; 95% CI -0.31 to 0.31); or in the time taken for the patient to return to work (two trials; 187 patients; MD 0.28 days; 95% CI -0.44 to 0.99) between the groups. There was no significant difference in the cosmesis scores at six months to 12 months after surgery between the two groups (two trials; 152 patients; SMD 0.13; 95% CI -0.19 to 0.46). AUTHORS' CONCLUSIONS: Miniport laparoscopic cholecystectomy can be completed successfully in more than 80% of patients. There appears to be no advantage of miniport laparoscopic cholecystectomy in terms of decreasing mortality, morbidity, hospital stay, return to activity, return to work, or improving cosmesis. On the other hand, there is a modest increase in operating time after miniport laparoscopic cholecystectomy compared with standard port laparoscopic cholecystectomy and the safety of miniport laparoscopic cholecystectomy is yet to be established. Miniport laparoscopic cholecystectomy cannot be recommended routinely outside well-designed randomised clinical trials. Further trials of low risks of bias and low risks of random errors are necessary.

Use of multivariate analysis to suggest a new molecular classification of colorectal cancer.

Molecular classification of colorectal cancer (CRC) is currently based on microsatellite instability (MSI), KRAS or BRAF mutation and, occasionally, chromosomal instability (CIN). Whilst useful, these categories may not fully represent the underlying molecular subgroups. We screened 906 stage II/III CRCs from the VICTOR clinical trial for somatic mutations. Multivariate analyses (logistic regression, clustering, Bayesian networks) identified the primary molecular associations. Positive associations occurred between: CIN and TP53 mutation; MSI and BRAF mutation; and KRAS and PIK3CA mutations. Negative associations occurred between: MSI and CIN; MSI and NRAS mutation; and KRAS mutation, and each of NRAS, TP53 and BRAF mutations. Some complex relationships were elucidated: KRAS and TP53 mutations had both a direct negative association and a weaker, confounding, positive association via TP53-CIN-MSI-BRAF-KRAS. Our results suggested a new molecular classification of CRCs: (1) MSI(+) and/or BRAF-mutant; (2) CIN(+) and/or TP53(-) mutant, with wild-type KRAS and PIK3CA; (3) KRAS- and/or PIK3CA-mutant, CIN(+) , TP53-wild-type; (4) KRAS(-) and/or PIK3CA-mutant, CIN(-) , TP53-wild-type; (5) NRAS-mutant; (6) no mutations; (7) others. As expected, group 1 cancers were mostly proximal and poorly differentiated, usually occurring in women. Unexpectedly, two different types of CIN(+) CRC were found: group 2 cancers were usually distal and occurred in men, whereas group 3 showed neither of these associations but were of higher stage. CIN(+) cancers have conventionally been associated with all three of these variables, because they have been tested en masse. Our classification also showed potentially improved prognostic capabilities, with group 3, and possibly group 1, independently predicting disease-free survival.

Miniport versus standard ports for laparoscopic cholecystectomy.

BACKGROUND: In conventional (standard) laparoscopic cholecystectomy, four abdominal ports (two of 10 mm diameter and two of 5 mm diameter) are used. Recently, use of smaller ports have been reported. OBJECTIVES: To assess the benefits and harms of miniport (defined as ports smaller than conventional ports) laparoscopic cholecystectomy versus standard laparoscopic cholecystectomy. 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 September 2009 for identifying the randomised trials. SELECTION CRITERIA: Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing miniport versus standard ports laparoscopic cholecystectomy were considered for the review. DATA COLLECTION AND ANALYSIS: Two authors collected the data independently. We analysed the data with both the fixed-effect and the random-effects models using RevMan Analysis. For each outcome we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI). MAIN RESULTS: We included thirteen trials with 803 patients randomised to miniport (n = 416) versus standard ports laparoscopic cholecystectomy (n = 387). In twelve trials, four ports were used. In one trial, three ports were used. The bias risk of all trials was high. Miniport laparoscopic cholecystectomy could be completed successfully in 87% of patients. The remaining patients were mostly converted to standard laparoscopic cholecystectomy but some were also converted to open cholecystectomy. Further information about these patients who underwent conversion to open cholecystectomy was not available in most trials. In the patients on whom information was available, there was no mortality reported; and there was no significant difference in the surgery-related morbidity or conversion to open cholecystectomy. Most trials excluded the patients who were converted to standard laparoscopic cholecystectomy. In patients who underwent successful miniport laparoscopic cholecystectomy, the pain was significantly lower in the miniport group than in the standard port at various time points. AUTHORS' CONCLUSIONS: Miniport laparoscopic cholecystectomy can be completed successfully in more than 85% of patients. Patients, in whom elective miniport laparoscopic cholecystectomy was completed successfully, had lower pain than those who underwent standard laparoscopic cholecystectomy. However, because of the lack of information on its safety, miniport laparoscopic cholecystectomy cannot be recommended outside well-designed, randomised clinical trials.

Surgical resection versus non-surgical treatment for hepatic node positive patients with colorectal liver metastases.

BACKGROUND: Involvement of hepatic lymph node in patients with colorectal liver metastases is associated with poor prognosis. OBJECTIVES: To determine the benefits and harms of curative liver resection with lymphadenectomy versus other treatments for colorectal liver metastases with hepatic node involvement. 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, Science Citation Index Expanded, and LILACS until September 2009 for identifying the randomised trials. SELECTION CRITERIA: We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing liver resection (alone or in combination with radiofrequency ablation or cryoablation) versus other treatments (neo-adjuvant chemotherapy, chemotherapy, or radiofrequency ablation) in patients with colorectal liver metastases with hepatic node involvement. DATA COLLECTION AND ANALYSIS: Two authors independently identified trials for inclusion. MAIN RESULTS: We were unable to identify any randomised clinical trial fulfilling the inclusion criteria of this review. We were also unable to identify any quasi-randomised or cohort studies, which could meaningfully answer this important issue. AUTHORS' CONCLUSIONS: There is no evidence in the literature to assess the role of surgery versus other treatments for patients with colorectal liver metastases with hepatic node involvement. High quality randomised clinical trials are feasible and are necessary to determine the optimal management of patients with colorectal liver metastases with hepatic node involvement.

Liver resection versus other treatments for neuroendocrine tumours in patients with resectable liver metastases.

BACKGROUND: Neuroendocrine tumours are tumours of cells, which possess secretory granules and originate from the neuroectoderm. While liver resection is generally advocated in patients with resectable liver metastases, recent studies have shown good survival in patients with disseminated neuroendocrine tumours who underwent thermal ablation using radiofrequency. OBJECTIVES: To determine the benefits and harms of liver resection versus other treatments in patients with resectable liver metastases from gastro-entero-pancreatic neuroendocrine tumours. 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, Science Citation Index Expanded and LILACS until July 2008 for identifying the randomised trials. SELECTION CRITERIA: We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing liver resection (alone or in combination with radiofrequency ablation or cryoablation) versus other interventions (chemotherapy, hormonotherapy, or immunotherapy) and those comparing liver resection and thermal ablation (radiofrequency ablation or cryoablation) in patients with resectable liver metastases from neuroendocrine tumours for the review. DATA COLLECTION AND ANALYSIS: Two authors independently identified trials for inclusion. MAIN RESULTS: We were unable to identify any randomised clinical trial suitable for inclusion in this review. We were also unable to identify any quasi-randomised studies, cohort studies, or case-control studies that could inform meaningfully. AUTHORS' CONCLUSIONS: There is no evidence from randomised clinical trials comparing liver resection versus other treatments in patients with resectable liver metastases from gastro-entero-pancreatic neuroendocrine tumours. Liver resection appears to be the main stay curative treatment for neuroendocrine liver metastases based on non-randomised studies. Further randomised clinical trials comparing liver resection alone or in combination with chemoembolisation or radionuclide therapy are needed. Further randomised clinical trials comparing surgical resection and radiofrequency ablation in selected patients may also be appropriate.

Vascular occlusion for elective liver resections.

BACKGROUND: Vascular occlusion is used to reduce blood loss during liver resection. There is considerable controversy regarding whether vascular occlusion should be used or not during elective liver resections. OBJECTIVES: To assess the advantages (decreased blood loss and peri-operative morbidity) and disadvantages (ischaemia-reperfusion injury related complications like liver dysfunction) of vascular occlusion during elective liver resections. 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 August 2008. SELECTION CRITERIA: We included randomised clinical trials comparing vascular occlusion versus no vascular occlusion during elective liver resections (irrespective of language or publication status). DATA COLLECTION AND ANALYSIS: Two authors independently assessed trials for inclusion and independently extracted the data. We analysed the data with both the fixed-effect and the random-effects models using RevMan Analysis. We calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI) based on intention-to-treat or available case analysis. MAIN RESULTS: We identified a total of five trials (of high bias-risk) which compared vascular occlusion (n = 166) versus no vascular occlusion (n = 165). Three of the five trials comparing vascular occlusion and no vascular occlusion used intermittent vascular occlusion. There was no difference in mortality, liver failure, or other morbidities. The blood loss was significantly lower in vascular occlusion compared with no vascular occlusion. The liver enzymes were significantly elevated in the vascular occlusion group compared with no vascular occlusion. AUTHORS' CONCLUSIONS: Intermittent vascular occlusion seems safe in liver resection. However, it does not seem to decrease morbidity. More randomised trials seem to be needed.