BIOPEX-2
Trial question
What is the role of perineal wound closure using gluteal turnover flap in patients with rectal cancer undergoing abdominoperineal resection?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 165
165 patients (57 female, 108 male).
Inclusion criteria: adult patients with rectal cancer undergoing primary abdominoperineal resection.
Key exclusion criteria: total pelvic exenteration or sacral resection above level S4 or S5; intersphincteric abdominoperineal resection; biological mesh closure; severe systemic diseases impacting wound healing.
Interventions
N=79 gluteal turnover flap closure (subcutaneous flap created from the gluteal region to fill the former anal canal).
N=86 primary perineal closure (remaining ischioanal skin closed primarily in the midline).
Primary outcome
Uncomplicated wound healing at 30 days
55%
60%
60.0 %
45.0 %
30.0 %
15.0 %
0.0 %
Gluteal turnover flap
closure
Primary perineal
closure
No significant
difference ↔
No significant difference in uncomplicated wound healing at 30 days (55% vs. 60%; ARD -5, 95% CI -21.75 to 11.75).
Secondary outcomes
Significant decrease in presacral abscess (9% vs. 22%; ARD -13, 95% CI -23.97 to -2.03).
No significant difference in perineal wound-related readmission (13% vs. 21%; ARD -8, 95% CI -19.41 to 3.41).
No significant difference in any reintervention (23% vs. 29%; ARD -6, 95% CI -19.22 to 7.22).
Conclusion
In adult patients with rectal cancer undergoing primary abdominoperineal resection, gluteal turnover flap closure was not superior to primary perineal closure with respect to uncomplicated wound healing at 30 days.
Reference
Saskia I Kreisel, Sarah Sharabiany, Jurriaan Tuynman et al. Perineal Wound Closure Using Gluteal Turnover Flap After Abdominoperineal Resection for Rectal Cancer: The BIOPEX-2 Randomized Clinical Trial. JAMA Surg. 2025 Feb 5:e246818. Online ahead of print.
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