Cost-utility of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma (GRECCAR-9)

March 2, 2021 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • Amiens university hospital
        • Principal Investigator:
          • Jean-Marc REGIMBEAU
      • Angers, France
        • Not yet recruiting
        • Angers University Hospital
        • Contact:
          • Aurélien Venara
        • Principal Investigator:
          • Aurélien VENARA
      • Besançon, France
        • Not yet recruiting
        • Besançon University Hospital
      • Bordeaux, France
      • Caen, France
        • Not yet recruiting
        • CAEN University Hospital
        • Contact:
        • Principal Investigator:
          • Arnaud ALVES
      • Clermont-Ferrand, France
      • Grenoble, France
        • Not yet recruiting
        • Grenoble University Hospital
        • Principal Investigator:
          • Bertrand TRILLING
      • Lille, France
      • Lille, France
      • Lyon, France
        • Not yet recruiting
        • Lyon university hospital
      • Marseille, France
        • Not yet recruiting
        • Paoli Calmettes Institut
        • Contact:
        • Principal Investigator:
          • Cécile De Chaisemartin
      • Nancy, France
        • Not yet recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
        • Principal Investigator:
          • Cécilia CERIBELLI
      • Nancy, France
        • Not yet recruiting
        • Nancy University Hospital
        • Contact:
        • Principal Investigator:
          • Adeline GERMAIN
      • Nantes, France
        • Not yet recruiting
        • Nantes University Hospital
        • Contact:
          • Emilie DUCHALAIS, MD
        • Principal Investigator:
          • Emilie DUCHALAIS
      • Paris, France
        • Not yet recruiting
        • Saint-Antoine Hospital
        • Principal Investigator:
          • Jérémie LEFEVRE
      • Rouen, France
        • Not yet recruiting
        • Rouen University Hospital
      • Toulouse, France, 31059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm with biological mesh
The intervention consists of perinal reconstruction using biological mesh (Cellis prosthesis from Meccellis Biotech, reference C1015E size 10x15cm)
Procedure: Biological mesh
The intervention consists of suturing a biological mesh in the pelvic floor defect. The mesh will be sutured at each side of the coccyx or distal sacrum and directly to the residual pelvic floor muscle and fascia by using interrupted or continuous hand-sewn sutures with an appropriate amount of tension. The mesh that will be used is the Cellis prosthesis from Meccellis Biotech, reference C1015E which size is 10x15cm.
Active Comparator: Arm with primary perineal wound closure
The intervention consists of perinal reconstruction by primary perineal wound closure
Procedure: Primary perineal wound closure
The intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental Cost-Utility Ratio (ICUR)
Time Frame: At 12 months
The primary endpoint in this study is based on the assessment of the incremental cost-utility ratio at 1 year, from the collective perspective between biological mesh perineal reconstructions versus. primary perineal closure in patients operated for anorectal carcinoma with proven rectal adenocarcinoma or anal canal epidermoid carcinoma.
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perineal wound healing
Time Frame: At 1, 3, 6, 9 and 12 months
The perineal wound healing will be assessed using the Southampton wound assessment scale (6-point scale ranging from 0=normal healing to V=deep or severe wound infection)
At 1, 3, 6, 9 and 12 months
Pain intensity
Time Frame: From date of randomization until the date of study participation end of patient, assessed up to 12 months
assessed on an 11-point Numeric Rating Scale (NRS) at baseline before surgical procedure and at least 3 times a day during hospital stay. Thereafter, patients will rate their pain intensity in a patient subject diary every day and immediately before each use of pain medication
From date of randomization until the date of study participation end of patient, assessed up to 12 months
Health related Quality of life
Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months
Health related quality of life will be assessed using the EuroQOL EQ-5D-5L questionnaire
1 month, 3 months, 6 months, 9 months, 12 months
Perineal complications
Time Frame: Daily during hospitalization and at 1, 3, 6, 9 and 12 months after surgery

Perineal complications include:

  • Perineal wound infection defined as a swelling of the wound or surrounding tissues with purulent discharge
  • Breakdown of the perineal wound included any wound dehiscence, sinus or ulcer
  • Pelvic abscess included a fluid collection in the pelvis
  • Perineal evisceration defined by exposure of the pelvic cavity through the perineal wound
  • Perineal hernia symptomatic or not
  • Perineal sinus defined as an incomplete healing after 6 months
Daily during hospitalization and at 1, 3, 6, 9 and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Etienne BUSCAIL, MD, University Hospital of Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2021

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/16/7940

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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