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

Rectal Cancer Clinical Trial

— BIOPEX2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04004650
• Other study ID #: NL65461.018.18
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Sarah Sharabiany, MD
• Phone: 0031653663288
• Email: s.sharabiany[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominoperineal Resection
• Rectal Cancer
• Rectal Neoplasms
• Wound Heal
• Wounds and Injuries

Intervention

Procedure:
• Gluteal turnover flap
Link to procedure: https://www.youtube.com/watch?v=u7_vH2_1ZZc

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam-Zuidoost	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perineal wound healing	Southampton wound score	14 days, 3 and 6 months postoperatively
Secondary	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
Secondary	Perineal hernia rate	lncidence of symptomatic and asymptomatic perineal hernia	1,3,6 months
Secondary	Health-related quality of life	questionnaires: The 5-level EQ-5D version (EQ-5D-5L)	1,3,6 months
Secondary	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
Secondary	Generic quality of Life	questionnaires: Short Form Survey (SF36)	3,6 months
Secondary	Urogenital Distress	questionnaires: Urogenital Distress Inventory (UDI-6)	1,3,6 months
Secondary	Incontinence scale	questionnaires:Incontinence Impact Questionnaire short form (IIQ-7)	1,3,6 months
Secondary	Urogenital function	questionnaires: international index of erectile function (IIEF)	1,3,6 months
Secondary	Female sexual distress	questionnaires: Female sexual distress scale (FSDS-R)	1,3,6 months