BIOPEX: Cost-effectiveness of biological mesh closure of the pelvic floor after extralevator abdominoperineal resection for rectal cancer.

Trial Overview

Acronym	BIOPEX
Number	NTR3717
Protocol Link	http://bmcsurg.biomedcentral.com/articles/10.1186/1471-2482-14-58
Public Trial Registry Link	https://clinicaltrials.gov/ct2/show/NCT01927497?term=BIOPEX&rank=1
Status	Published
Category	Colorectal Cancer - Rectal Specific
Treatment Course	Surgery

Trial Description

The primary objective of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after eAPR with neo-adjuvant radiotherapy compared to primary perineal closure. It is a multicentre, single blinded, randomized controlled trial, in which eligible patients will be randomized between pelvic floor reconstruction using a biological mesh (intervention arm) and primary closure of the perineal defect (standard arm) in a 1:1 ratio.

Chief Investigator

G.D. Musters
MD

Profile Link

Lead Centre

Academic Medical Centre (AMC) Amsterdam
Meibergdreef 9
Amsterdam
1105
Netherlands

Website

Collaboration and Funding

Collaborative Sites

Additional Information

Full Research Summary

Objective:	The aim of this study is to determine the cost-effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy.
Aim:	.
Methods:	Study design: This is a multicenter study in which patients undergoing an eAPR are randomized between standard care using primary closure of the perineum and the experimental arm with assisted closure using a biological mesh. Study population: Patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy. A total number of 104 patients will be randomized. Intervention: The intervention in the experimental arm consists of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Main study parameters/endpoints: The primary endpoint is the percentage of uncomplicated perineal wound healing (Souphampton wound score less than II at day 30). Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both primary perineal closure and biological mesh assisted closure are being performed in daily clinical practise. The potential benefit resulting from participation of the study in patients randomized for biological mesh assisted closure may be a higher chance of uncomplicated perineal wound healing and lower perineal hernia rate. On the other hand, the use of a biological mesh has been associated with increased postoperative pain and seroma formation.
Reason for International Trial:	.