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

  NCT01927497

  CompletedInterventionalPhase 3Updated Aug 17, 2021
• APEMESH II - Perineal Reconstruction

  NCT04779125

  CompletedInterventionalNot ApplicableUpdated Feb 1, 2024
• Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection

  NCT01722565

  CompletedInterventionalPhase 4Updated Sep 10, 2015
• APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

  NCT04334421

  CompletedObservationalUpdated Feb 1, 2024
• Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction

  NCT02703662

  Unknown statusInterventionalPhase 2Phase 3Updated Feb 3, 2023
• Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery

  NCT02576184

  CompletedInterventionalNot ApplicableUpdated Nov 22, 2021

ClinicalTrials.gov ID

NCT02841293

Lead Sponsor

University Hospital, ToulouseOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

140Estimated

Last Update Posted

Mar 4, 2021Actual

Start Date

Feb 7, 2021Actual

Primary Completion Date

Feb 2024Estimated

Completion Date

Feb 2024Estimated

Official Title

Cost-utility Evaluation of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma: Perineal Filling With Biological Meshes vs. Primary Perineal Wound Closure

Brief Summary

Abdominoperineal resection performed for anorectal tumors leaves a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40 - 60 %). Biological meshes offer possibility for a new standard of perineal wound reconstruction. Perineal filling with biological mesh is expected to increase quality of life by reducing perineal morbidity.

Detailed Description

Perineal wound problems after abdominoperineal resection (APR) in the context of cancer are frequent. These types of resection problems occur because of wound complications caused by large perineal defects. Indeed, perineal wound complications, perineal abscess, wound dehiscences, chronic fistulas and sinuses lengthen the hospital stays. Futhermore, the standardization of the surgery since the late 2000s and the extralevator technique lead a larger defect and increase i perineal complications.

Several strategies are used to decrease the complication rate. Closure by direct approximation of the pelvic muscles leads to a rate of major complication up to 57% depending on the series. Musculocutaneous flaps help to reduce this rate (16- 65%) but they generate their own morbidity, require experience and increase the costs of care. Finally, the use of biologic meshes since the beginning of 2010 seems to have improve the healing process. However, results are still variable and the only randomized study comparing direct closure and mesh closure showed no significant results at one year. Another ongoing randomized trial is comparing gluteus maximus flap to mesh closure and focusing on physical performances.

This increase in post-operative complications and their consequences causes an increase in costs. In addition, they affect the patients' quality of life and lead to a loss of productivity. From an oncological point of view, perineal scarring problems can cause a delay in the adjuvant therapeutic sequence. Few studies have highlighted the efficiency of perineal wound complications, using cost-effectiveness analyses. In order to clarify the best strategy comparing primary and mesh closure in term of cost effectiveness on perineal healing after ELAPE, we designed this randomized controlled trial.

• Abdominoperineal Resection

• Biological mesh
• Primary perineal wound closure

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Age ≥ 18

• Eastern Cooperative Oncology Group performance status score of 2 or less

• Histologically proven rectal adenocarcinoma or anal canal epidermoïd carcinoma

• Abdominoperineal resection indication after multidisciplinary team discussion:

  • for rectal adenocarcinoma: circumferential MRI margin equal or less than 1 mm from closest tumoral structure and a striated muscular layer (levator ani or external anal sphincter)
  • for epidermoid carcinoma: residual or recurrent tumour after chemoradiotherapy.

• Voluntary written informed consent

• Patients with social security insurance or equivalent social protection

Exclusion Criteria:

• T4 tumour needing a surgical extensive resection with reconstruction by a musculocutaneous flap
• Metastasis disease deemed unresectable with curative intent
• Previous pelvic radiotherapy for another disease than the rectal or anal cancer
• Immunosuppressive drugs treatment
• Uncontrolled diabetes (glycosylated hemoglobin (HbA1c) > 8 % despite adequate therapy)
• Patient under juridical protection.
• Sensitivity to porcine derived products.
• Enrolment in trial with overlapping primary endpoint.
• Pregnant women
• Breastfeeding women

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

University Hospital, ToulouseOTHER

Guillaume.piessen@chru.lille.fr