Intraoperative Wound Irrigation for the Prevention of Surgical Site Infection After Laparotomy: A Randomized Clinical Trial by CHIR-Net.

Importance: Surgical site infections frequently occur after open abdominal surgery. Intraoperative wound irrigation as a preventive measure is a common practice worldwide, although evidence supporting this practice is lacking. Objective: To evaluate the preventive effect of intraoperative wound irrigation with polyhexanide solution. Design, Setting, and Participants: The Intraoperative Wound Irrigation to Prevent Surgical Site Infection After Laparotomy (IOWISI) trial was a multicenter, 3-armed, randomized clinical trial. Patients and outcome assessors were blinded to the intervention. The clinical trial was conducted in 12 university and general hospitals in Germany from September 2017 to December 2021 with 30-day follow-up. Adult patients undergoing laparotomy were eligible for inclusion. The main exclusion criteria were clean laparoscopic procedures and the inability to provide consent. Of 11 700 screened, 689 were included and 557 completed the trial; 689 were included in the intention-to-treat and safety analysis. Interventions: Randomization was performed online (3:3:1 allocation) to polyhexanide 0.04%, saline, or no irrigation (control) of the operative wound before closure. Main Outcome and Measures: The primary end point was surgical site infection within 30 postoperative days according to the US Centers for Disease Control and Prevention definition. Results: Among the 689 patients included, 402 were male and 287 were female. The median (range) age was 65.9 (18.5-94.9) years. Participants were randomized to either wound irrigation with polyhexanide (n = 292), saline (n = 295), or no irrigation (n = 102). The procedures were classified as clean contaminated in 92 cases (8%). The surgical site infection incidence was 11.8% overall (81 of 689), 10.6% in the polyhexanide arm (31 of 292), 12.5% in the saline arm (37 of 295), and 12.8% in the no irrigation arm (13 of 102). Irrigation with polyhexanide was not statistically superior to no irrigation or saline irrigation (hazard ratio [HR], 1.23; 95% CI, 0.64-2.36 vs HR, 1.19; 95% CI, 0.74-1.94; P = .47). The incidence of serious adverse events did not differ among the 3 groups. Conclusions and Relevance: In this study, intraoperative wound irrigation with polyhexanide solution did not reduce surgical site infection incidence in clean-contaminated open abdominal surgical procedures compared to saline or no irrigation. More clinical trials are warranted to evaluate the potential benefit in contaminated and septic procedures, including the emergency setting. Trial Registration: drks.de Identifier: DRKS00012251.

Surgical site infection prevention in abdominal surgery: is intraoperative wound irrigation with antiseptics effective? Protocol for a systematic review and meta-analysis.

INTRODUCTION: Surgical site infection (SSI) after laparotomy still represents the most frequent postoperative complicationin abdominal surgery. The effectiveness of reducing SSI rates by intra-operative irrigation of the incisional wound with antiseptic solutions or saline has been much debated, and recommendations on its use are divergent. Therefore, we aim to conduct a systematic review and meta-analysis, focusing specifically on procedures by laparotomy and considering recent evidence only. METHODS AND ANALYSIS: The systematic review and meta-analysis were conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) statement. On 1 July 2022, PubMed/MEDLINE, Cochrane, Central Register of Controlled Trials and EMBASE were searched for the following predefined terms: (Surgical site infection) AND ((irrigation) OR (wound irrigation) OR (lavage)) AND ((abdominal surgery) OR (laparotomy). The search was limited to peer-revied publications, dating after 1 January 2000 in English or German language. Systematic reviews and meta-analyses were included for reference screening. Case reports, case series, non-systematic reviews and studies without follow-up information were excluded. The primary outcome is the rate of postoperative SSI after abdominal surgery by laparotomy. Meta-analysis is pooled using the Mantel-Haenszel method for random effects. The risk of bias in randomised studies will be assessed using the Cochrane developed RoB 2-tool, and the ROBINS-I tool for non-randomised studies. Completion of the analysis and publication is planned in March 2023. ETHICS AND DISSEMINATION: Ethical approval is not necessary for this study, as no new data will be collected. The results of the final study will be published in a peer-reviewed open-access journal. PROSPERO REGISTRATION NUMBER: CRD42022321458.

The impact of prior endoscopic or surgical therapy on open Zenker's diverticulum surgery: analysis on a large single center cohort : Comparison of primary and revisional open surgery for Zenker's diverticulum.

BACKGROUND: Endoscopic treatment of Zenker's diverticulum is an attractive minimally invasive alternative compared to the classic open approach. However, increased recurrence rate were reported. In case of relapse, endoscopic therapy might be repeated, or alternatively open surgery is performed. This study aimed to identify potential differences in the outcomes between primary or secondary surgical treatment in Zenker's diverticulum. METHODS: From January 2003 to April 2019, 227 subsequent patients underwent surgical diverticulectomy and cervical myotomy at the surgical department of TUM. 41 of 227 patients had received previous therapy, either open or endoscopic. Perioperative parameters in priorly untreated patients were retrospectively compared to those after previous therapy (mostly endoscopic) with special regard to perioperative data and postoperative complications. Univariate and multivariate regression analyses were performed to identify predictors for postoperative complications. RESULTS: We could show that the number of complications (p = 0.047) in pretreated patients is significant higher as well as the severity after Clavien-Dindo (p = 0.025). Stapler line leakage, wound infections, and operative revision rate was higher also pretreated group. Pretreatment and surgery time showed a significant association with postoperative complications in univariate analysis. In multivariate analysis, pretreatment remained a significant independent predictor of complications. CONCLUSION: The present data indicate that endoscopic therapy might represent a risk factor for postoperative complications in case of relapse surgery. Therefore primary open surgery should be debated in patients with an increased high risk of relapse.

UICC Staging after Neoadjuvant/Perioperative Chemotherapy Reveals No Significant Survival Differences Compared to Primary Surgery for Locally Advanced Gastric Cancer.

Background: The applicability of UICC TNM staging for gastric cancer (GC) patients treated with neoadjuvant chemotherapy (nCTX) and surgery was not yet analyzed in comparison to patients undergoing primary surgery (PS). The purpose of this analysis was to analyze if the prognostic impact of TNM staging after nCTx is comparable with PS. Methods: Data for patients having been treated for GC with or without nCTx between 1990 and 2016 were analyzed. Uni-(URA) and multivariable regression analyses (MRA) were performed to identify predictors. Survival according to the UICC 8th edition stages was analyzed by the Kaplan−Meier method and cox regression analysis. Propensity score matching (PSM) was performed to balance for confounders. Results: 1149 patients with GC were eligible for primary analysis. URA demonstrated age (p < 0.0001), tumor localization (p < 0.0001), clinical UICC-stage, complications, UICC stage 0, IIB-IIIC, Lauren subtype, grading, and R-stage to be significantly associated with OS. MRA revealed that age, distal tumor localization, more than 25 dissected lymph nodes, UICC stage 0, IIB-IIIC, and Lauren subtype were significantly and independently related to OS. After PSM, survival analyses revealed only a significant difference for pN2/ypN2 (p = 0.03), while all other T and N stages were comparable. Conclusion: UICC dependent survival stages do not change significantly after nCTx treatment for GC. Therefore, UICC staging in its present version is applicable to patients undergoing nCTx.