International journal of surgery (London, England) · 2025
Using a composite end-point and WIN-ratio analysis to evaluate perineal wound healing after abdominoperineal resection for rectal cancer: further insights from the BIOPEX trials.
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van den Berg Rudolf, Musters Gijsbert D, Kreisel Saskia I, van Gerwen Nina, Verhoef Kees, Tanis Pieter J, Sharabiany S, Tuynman J B, Hompes R, Belgers Ehj, Singh B, Chaudhri S, van Geloven Aaw, Vuylsteke Rjclm, de Wilt Jhw, Melenhorst J, Leijtens Jwa, Vermaas M, Rothbarth J, Burger Jwa, Polat F, Fabry Hfj, Aalbers Agj, Wijsman J H, Lamme B, van de Ven A, Lapid O, Blok Rd, Bosker Rji, van Duijvendijk P, van Etten B, Hoff C, BIOPEX and BIOPEX-2 collaborators and BIOPEX and BIOPEX-2 collaborators
Аннотация
BACKGROUND: Various strategies have been explored to reduce perineal wound-related morbidity after abdominoperineal resection for rectal cancer. The two BIOPEX trials evaluated the role of biological mesh closure and gluteal turnover flap, but both were negative at their primary endpoint (30-day wound healing). However, several secondary endpoints at different time points might be of clinical relevance.
MATERIALS AND METHODS: This was a post-hoc analysis of the BIOPEX and BIOPEX-2 trials. A composite endpoint was defined based on Southampton wound score 2-3 or 4-5 at five different time points during the 12-month postoperative period, presacral abscess, perineal-wound related radiological or surgical reintervention, and readmission. Win-ratio analysis was used, which prioritizes outcomes based on their importance. Sensitivity analyses were conducted and additionally a points-based scoring system was applied to evaluate the degree of wound healing complications.
RESULTS: A total of 269 patients were included. The win-ratio analysis revealed a net benefit for biological mesh closure in the BIOPEX study (15.4%, 95%CI -5.4%-36.7%), and for gluteal turnover flap in the BIOPEX-2 study (16.9%, 95%CI 0.1%-33.2%) compared to primary perineal closure, but only the latter reached statistical significance. Various sensitivity analyses showed robustness of the win-ratio results with comparable estimates. Points-based regression analysis did not reveal significant differences: IRR 0.76 (95%CI 0.38-1.52, p = 0.441) and IRR 0.67 (95%CI 0.40-1.14, p = 0.139), respectively.
CONCLUSION: This post-hoc analysis sheds new light on perineal wound healing in randomized studies by integrating various outcome measures. Although a similar numerical advantage of the intervention was shown in both BIOPEX trials using win-ratio analysis, it only reached statistical significance for the gluteal turnover flap.
MATERIALS AND METHODS: This was a post-hoc analysis of the BIOPEX and BIOPEX-2 trials. A composite endpoint was defined based on Southampton wound score 2-3 or 4-5 at five different time points during the 12-month postoperative period, presacral abscess, perineal-wound related radiological or surgical reintervention, and readmission. Win-ratio analysis was used, which prioritizes outcomes based on their importance. Sensitivity analyses were conducted and additionally a points-based scoring system was applied to evaluate the degree of wound healing complications.
RESULTS: A total of 269 patients were included. The win-ratio analysis revealed a net benefit for biological mesh closure in the BIOPEX study (15.4%, 95%CI -5.4%-36.7%), and for gluteal turnover flap in the BIOPEX-2 study (16.9%, 95%CI 0.1%-33.2%) compared to primary perineal closure, but only the latter reached statistical significance. Various sensitivity analyses showed robustness of the win-ratio results with comparable estimates. Points-based regression analysis did not reveal significant differences: IRR 0.76 (95%CI 0.38-1.52, p = 0.441) and IRR 0.67 (95%CI 0.40-1.14, p = 0.139), respectively.
CONCLUSION: This post-hoc analysis sheds new light on perineal wound healing in randomized studies by integrating various outcome measures. Although a similar numerical advantage of the intervention was shown in both BIOPEX trials using win-ratio analysis, it only reached statistical significance for the gluteal turnover flap.