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Objective: To determine long-term outcomes of a randomized trial (BIOPEX) comparing biological mesh and primary perineal closure in rectal cancer patients after extralevator abdominoperineal resection and preoperative radiotherapy, with a primary focus on symptomatic perineal hernia.

Summary Background Data: BIOPEX is the only randomized trial in this field, which was negative on its primary endpoint (30-day wound healing).

Methods: This was a posthoc secondary analysis of patients randomized in the BIOPEX trial to either biological mesh closure (n = 50; 2 dropouts) or primary perineal closure (n = 54; 1 dropout). Patients were followed for 5 years. Actuarial 5-year probabilities were determined by the Kaplan-Meier statistic.

Results: Actuarial 5-year symptomatic perineal hernia rates were 7% (95% CI, 0-30) after biological mesh closure versus 30% (95% CI, 10-49) after primary closure (P = 0.006). One patient (2%) in the biomesh group underwent elective perineal hernia repair, compared to 7 patients (13%) in the primary closure group (P = 0.062). Reoperations for small bowel obstruction were necessary in 1/48 patients (2%) and 5/53 patients (9%), respectively (P = 0.208). No significant differences were found for chronic perineal wound problems, locoregional recurrence, overall survival, and main domains of quality of life and functional outcome.

Conclusions: Symptomatic perineal hernia rate at 5-year follow-up after abdominoperineal resection for rectal cancer was significantly lower after biological mesh closure. Biological mesh closure did not improve quality of life or functional outcomes.

Competing Interests: The remaining authors report no conflicts of interest.

Titel:	Cumulative 5-year Results of a Randomized Controlled Trial Comparing Biological Mesh With Primary Perineal Wound Closure After Extralevator Abdominoperineal Resection (BIOPEX-study).
Autor/in / Beteiligte Person:	Blok, RD ; Sharabiany, S ; Stoker, J ; Laan, ETM ; Bosker, RJI ; Burger, JWA ; Chaudhri, S ; van Duijvendijk P ; van Etten B ; van Geloven AAW ; de Graaf EJR ; Hoff, C ; Hompes, R ; Leijtens, JWA ; Rothbarth, J ; Rutten, HJT ; Singh, B ; Vuylsteke, RJCLM ; de Wilt JHW ; Dijkgraaf, MGW ; Bemelman, WA ; Musters, GD ; Tanis, PJ
Link:	Full Text Finder (Volltext)
Zeitschrift:	Annals of surgery, Jg. 275 (2022), Heft 1, S. e37-e44
Veröffentlichung:	Philadelphia, PA : Lippincott Williams & Wilkins, 2022
Medientyp:	academicJournal
ISSN:	1528-1140 (electronic)
DOI:	10.1097/SLA.0000000000004763
Schlagwort:	Adult Female Follow-Up Studies Humans Incisional Hernia etiology Male Middle Aged Postoperative Complications etiology Prospective Studies Quality of Life Rectal Neoplasms surgery Time Factors Wound Healing Herniorrhaphy methods Incisional Hernia surgery Perineum surgery Postoperative Complications surgery Proctectomy adverse effects Surgical Mesh Wound Closure Techniques
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Language: English [Ann Surg] 2022 Jan 01; Vol. 275 (1), pp. e37-e44. MeSH Terms: Surgical Mesh* ; Wound Closure Techniques* ; Herniorrhaphy / methods ; Incisional Hernia / surgery ; Perineum / surgery ; Postoperative Complications / surgery ; Proctectomy / *adverse effects ; Adult ; Female ; Follow-Up Studies ; Humans ; Incisional Hernia / etiology ; Male ; Middle Aged ; Postoperative Complications / etiology ; Prospective Studies ; Quality of Life ; Rectal Neoplasms / surgery ; Time Factors ; Wound Healing References: Blok RD, de Jonge J, de Koning MA, et al. Propensity score adjusted comparison of pelviperineal morbidity with and without omentoplasty following abdominoperineal resection for primary rectal cancer. Dis Colon Rectum 2019; 62:952–959. ; Blok RD, Musters GD, Borstlap WAA, et al. 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Cumulative 5-year Results of a Randomized Controlled Trial Comparing Biological Mesh With Primary Perineal Wound Closure After Extralevator Abdominoperineal Resection (BIOPEX-study).