Biological Mesh Closure of the Pelvic Floor After Extralevator Abdomino Perineal Resection for Rectal Cancer

Phase 3

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: Biological mesh assisted perineal closure; Procedure: Primary perineal closure

• Registration Number: NCT01927497
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of positive margins and improves oncological outcome in distal rectal cancer. However, wider excisions increase wound healing problems and development of perineal hernia. This has resulted in a progressive increase of the use of musculocutaneous flaps and biological meshes associated with a substantial increase of costs, which is not supported by proper data.

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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-08
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-22
• Primary Completion: 2014-09-01
• Study Completion: 2015-09-01
• Results First Submitted: 2019-07-13
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-23
• Last Update Submitted: 2021-07-23
• Results First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Age of 18 years or higher.
2. Planned for eAPR for primary rectal cancer.
3. Life expectancy of more than 2 years.
4. Ability to return for all scheduled and required study visits.
5. Preoperative (chemo)radiotherapy.
6. Written informed consent for study participation.

Exclusion Criteria

1. Previous pelvic irradiation for other cancers (i.e. prostate cancer).
2. Total exenteration or sacral resection above level S4/S5.
3. Sensitivity to porcine derived products or polysorbate.
4. Severe systemic diseases affecting wound healing (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV).
5. Collagen disorders (i.e. Marfan).
6. Enrolment in trials with overlapping primary endpoint or otherwise expected influence on wound healing (i.e. biological therapy like antiangiogenic agents).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biological mesh closure	Biological mesh assisted perineal closure	Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection
Primary perineal closure	Primary perineal closure	Primary perineal closure after extralevator abdomino perineal resection

Primary Outcome Measures

Name	Time	Method
30-day Uncomplicated Perineal Wound Healing	From operation to 30 days after the operation	uncomplicated perineal wound healing is defined as a Souphampton wound score less than II

Trial Locations

Locations (1)

Academic Medical Cener; 🇳🇱 Amsterdam, Noord-holland, Netherlands