Abstract / Summary
In rectal cancer patients undergoing abdominoperineal resection (APR), a gluteal turnover flap has been proposed to reduce perineal morbidity; however, its cost-effectiveness remains unclear. This multicentre randomized clinical trial evaluated the cost-effectiveness of perineal closure with a gluteal turnover flap compared with primary closure after APR for rectal cancer. This secondary analysis of the BIOPEX-2 trial enrolled patients undergoing APR for rectal cancer at 19 hospitals (18 in the Netherlands, 1 in the UK) who were randomized in 1:1 to primary closure or gluteal turnover flap closure. Outcome assessors for wound healing and interviewers collecting cost and quality-of-life data were blinded to allocation. The outcome of interest was 12-month cost-effectiveness, including procedural costs, post-hospitalization care, wound care, rehospitalization, workforce participation, and health-related quality of life (QoL), as measured by EQ-5D™ and EQ-VAS scores collected via blinded telephone interview at ≥ 24 months. Missing data were handled by multiple imputation. Mean costs were calculated, and bootstrapping was used to estimate cost differences. QoL was compared between groups according to the presence of perineal complications. The BIOPEX-2 trial randomized 175 patients; of these, 165 patients were analysed for the cost-effectiveness study (86 in the primary closure group, 79 in the gluteal turnover flap closure group). The mean total cost was €53 397 (95% confidence interval (c.i.) €46 645 to €60 149) for primary closure and €45 079 (95% c.i. €42 201 to €47 957) for gluteal turnover flap closure, yielding a mean cost reduction of €8318 (95% c.i. €928 to €15 709) favouring the gluteal turnover flap. The primary closure group had higher outpatient (total €71 316 versus €53 387), specialized wound (mean €1200 versus €720), and home care (mean €3842 versus €2504) costs. Patients with perineal complications reported significantly lower EQ-VAS and EQ-5D™ scores. Although these complications occurred more frequently in the primary closure group, no significant differences in QoL were observed between the randomization groups. Gluteal turnover flap closure is a cost-saving strategy for perineal wound closure following APR in patients with rectal cancer. These findings support broader implementation and offer potential benefits for both patients and healthcare providers. Registration number: NCT04004650 (http://www.clinicaltrials.gov).
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