TY - JOUR
T1 - Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer A Multicenter Randomized Controlled Trial (the BIOPEX-study)
AU - Musters, Gijsbert D.
AU - Klaver, Charlotte E. L.
AU - Bosker, Robbert J. I.
AU - Burger, Jacobus W. A.
AU - van Duijvendijk, Peter
AU - van Etten, Boudewijn
AU - van Geloven, Anna A. W.
AU - de Graaf, Eelco J. R.
AU - Hoff, Christiaan
AU - Leijtens, Jeroen W. A.
AU - Rutten, Harm J. T.
AU - Singh, Baljit
AU - Vuylsteke, Ronald J. C. L. M.
AU - de Wilt, Johannes H. W.
AU - Dijkgraaf, Marcel G. W.
AU - Bemelman, Willem A.
AU - Tanis, Pieter J.
PY - 2017/6
Y1 - 2017/6
N2 - Objective: To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR).Background: Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing.Methods: Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm). A non-cross-linked porcine acellular dermal mesh was sutured to the pelvic floor remnants in the intervention arm, followed by a layered closure of the ischioanal and subcutaneous fat and skin similar to the control intervention. The outcome of the randomization was concealed from the patient and perineal wound assessor. The primary endpoint was the rate of uncomplicated perineal wound healing defined as a Southampton wound score of less than 2 at 30 days postoperatively. Patients were followed for 1 year.Results: In total, 104 patients were randomly assigned to primary closure (n = 54; 1 dropouts) and biological mesh closure (n = 50; 2 dropouts). Uncomplicated perineal wound healing rate at 30 days was 66% (33/50; 3 not evaluable) after primary closure, which did not significantly differ from 63% (30/48) after biological mesh closure [relative risk 1.056; 95% confidence interval (CI) 0.7854-1.4197; P = 0.7177). Freedom from perineal hernia at 1 year was 73% (95% CI 60.93-85.07) versus 87% (95% CI 77.49-96.51), respectively (P = 0.0316).Conclusions: Perineal wound healing after eAPR with preoperative radiotherapy for rectal cancer was not improved when using a biological mesh. A significantly lower 1-year perineal hernia rate after biological mesh closure is a promising secondary finding that needs longer follow-up to determine its clinical relevance.
AB - Objective: To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR).Background: Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing.Methods: Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm). A non-cross-linked porcine acellular dermal mesh was sutured to the pelvic floor remnants in the intervention arm, followed by a layered closure of the ischioanal and subcutaneous fat and skin similar to the control intervention. The outcome of the randomization was concealed from the patient and perineal wound assessor. The primary endpoint was the rate of uncomplicated perineal wound healing defined as a Southampton wound score of less than 2 at 30 days postoperatively. Patients were followed for 1 year.Results: In total, 104 patients were randomly assigned to primary closure (n = 54; 1 dropouts) and biological mesh closure (n = 50; 2 dropouts). Uncomplicated perineal wound healing rate at 30 days was 66% (33/50; 3 not evaluable) after primary closure, which did not significantly differ from 63% (30/48) after biological mesh closure [relative risk 1.056; 95% confidence interval (CI) 0.7854-1.4197; P = 0.7177). Freedom from perineal hernia at 1 year was 73% (95% CI 60.93-85.07) versus 87% (95% CI 77.49-96.51), respectively (P = 0.0316).Conclusions: Perineal wound healing after eAPR with preoperative radiotherapy for rectal cancer was not improved when using a biological mesh. A significantly lower 1-year perineal hernia rate after biological mesh closure is a promising secondary finding that needs longer follow-up to determine its clinical relevance.
KW - abdominoperineal resection
KW - biological mesh
KW - perineal wound healing
KW - perineal wound infection
KW - primary perineal wound closure
KW - SHORT-TERM OUTCOMES
KW - EXCISION ELAPE
KW - RECONSTRUCTION
KW - EXPERIENCE
KW - METAANALYSIS
KW - SURGERY
U2 - 10.1097/SLA.0000000000002020
DO - 10.1097/SLA.0000000000002020
M3 - Article
C2 - 27768621
SN - 0003-4932
VL - 265
SP - 1074
EP - 1081
JO - Annals of Surgery
JF - Annals of Surgery
IS - 6
ER -