Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer (BIOPEX2)

Background:

About 700 patients per year undergo an abdominoperineal resection (APR) for distal rectal cancer (Dutch Colorectal Audit 2016).Neoadjuvant (chemo)radiotherapy is often used to further improve locoregional control. Morbidity after APR is substantial and mainly consisting of perineal wound problems in about 35% of the patients. lf primary healing of the perineal wound after APR doesn't occur, secondary healing can take up to one year, and there is even a small proportion of patients in whom a chronic perineal wound or fistula persists after one year. During this long period, intensive wound care is necessary. This results in a heavy burden on both patient and health care resources.

Objective:

The high morbidity rate of the perineal wound has resulted in a continuing discussion on how to close the perineal defect after APR. Our research group recently published the BIOPEX-study (NL42094.018.12), in which 104 patients were randomized between primary perinea! wound closure and biological mesh closure of the pelvic floor after APR with preoperative radiotherapy for rectal cancer. Similar uncomplicated perineal wound healing rate at 30 days (Southampton wound score < 2) was found: 63% versus 66%, respectively. The hypothesis behind this negative trial result is related to the perineal dead space between the skin and the biological mesh. Fluid will accumulate in this dead space with the risk of secondary contamination and abscess formation, leading to wound dehiscence and purulent discharge. Autologous tissue flaps have been suggested to improve perineal wound healing based on several cohort studies. At least in the Netherlands, these flaps are used only for selected patients with the large defects and highest risk of wound problems, because of the more extensive surgery with added surgical trauma and operative time, and associated donor site morbidity. For these reasons, primary perineal closure (control arm of BIOPEX) is still the standard of care in the Netherlands.

A gluteal turnover flap (GT flap) is a small transposition flap trom the unilateral adjacent perineal skin and subcutaneous fat, which is flipped into the perineal dead space, and stitched with the de-epithelialised dermis to the contralateral pelvic floor remnant. Subsequently, the perineal subcutaneous fat and skin are closed over the flap in the midline, thereby not adding a donor site scar. A small pilot study trom our group showed that this is a promising solution for routine perineal closure after APR.

Study design:

In this multicenter single blinded study, eligible patients will be randomized between pelvic floor reconstruction using a GT flap (intervention arm) and primary closure of the perineal defect (standard arm). The perineal wound healing will be evaluated at 14 days and 1, 3, and 6 months post-operatively using the Southampton wound scoring system by an independent observer.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer; Wound Heal; Abdominoperineal Resection
• Intervention / Treatment: Procedure: Gluteal turnover flap

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Sharabiany, MD; Phone Number: 0031653663288; Email: s.sharabiany@amsterdamumc.nl
• Study Contact Backup: Name: Gijsnert Musters, MD, PhD; Email: g.d.musters@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam-Zuidoost, Noord-Holland, Netherlands, 1105AZ
      • Recruiting
      • Amsterdam UMC, location AMC
      • Contact: Sarah Sharabiany, MD; Phone Number: 0031653663288; Email: s.sharabiany@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• clinical diagnosis of primary rectal cancer or recurrent rectal cancer
• scheduled for abdominalperineal resection
• older then 18 years

Exclusion Criteria:

• intersphincteric APR
• (biological) mesh placement
• extended resections (sacral resection except for coccyx resection, (posterior) exenteration)
• severe systemic diseases affecting wound healing except diabetes (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV), collagen disorders (i.e. Marfan)
• enrolment in other trials with overlapping primary endpoint.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Primary closure; Primary perineal closure after extralevator abdomino perineal resection
Experimental: Gluteal turnover flap; Gluteal flap reconstruction of the pelvic floor after extralevator abdomino perineal resection	Procedure: Gluteal turnover flap; Link to procedure: https://www.youtube.com/watch?v=u7_vH2_1ZZc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perineal wound healing rate 30 days	The primary endpoint of the study is the percentage of uncomplicated perineal wound healing defined as a Southampton wound score of less than Il at 30 days postoperatively.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perineal wound healing	Southampton wound score	14 days, 3 and 6 months postoperatively
Re-intervention or re-admission rate	Need tor re-intervention or re-admission related to pre-sacral abscess or either perineal wound problems.	1,3,6 months
Perineal hernia rate	lncidence of symptomatic and asymptomatic perineal hernia	1,3,6 months
Health-related quality of life	questionnaires: The 5-level EQ-5D version (EQ-5D-5L)	1,3,6 months
Quality of Life in cancer patients	questionnaires: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (C30-QL2, CR29)	1,3,6 months
Generic quality of Life	questionnaires: Short Form Survey (SF36)	3,6 months
Urogenital Distress	questionnaires: Urogenital Distress Inventory (UDI-6)	1,3,6 months
Incontinence scale	questionnaires:Incontinence Impact Questionnaire short form (IIQ-7)	1,3,6 months
Urogenital function	questionnaires: international index of erectile function (IIEF)	1,3,6 months
Female sexual distress	questionnaires: Female sexual distress scale (FSDS-R)	1,3,6 months

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Pieter Tanis, Prof. MD. Phd, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

General Publications

• Sharabiany S, Blok RD, Lapid O, Hompes R, Bemelman WA, Alberts VP, Lamme B, Wijsman JH, Tuynman JB, Aalbers AGJ, Beets GL, Fabry HFJ, Cherepanin IM, Polat F, Burger JWA, Rutten HJT, Bosker RJI, Talsma K, Rothbarth J, Verhoef C, van de Ven AWH, van der Bilt JDW, de Graaf EJR, Doornebosch PG, Leijtens JWA, Heemskerk J, Singh B, Chaudhri S, Gerhards MF, Karsten TM, de Wilt JHW, Bremers AJA, Vuylsteke RJCLM, Heuff G, van Geloven AAW, Tanis PJ, Musters GD. Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study). BMC Surg. 2020 Jul 23;20(1):164. doi: 10.1186/s12893-020-00823-7.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Wounds and Injuries; Rectal Neoplasms
• Other Study ID Numbers: NL65461.018.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No