NCT02841293

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

17 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
4.6 years until next milestone

Study Start

First participant enrolled

February 7, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

July 12, 2016

Last Update Submit

March 2, 2021

Conditions

Abdominoperineal Resection

Keywords

anorectal carcinomaperineal fillingcost-utility analysisbiological meshesprimary perineal wound closure

Outcome Measures

Primary Outcomes (1)

  • Incremental Cost-Utility Ratio (ICUR)

    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 Outcomes (4)

  • Perineal wound healing

    At 1, 3, 6, 9 and 12 months

  • Pain intensity

    From date of randomization until the date of study participation end of patient, assessed up to 12 months

  • Health related Quality of life

    1 month, 3 months, 6 months, 9 months, 12 months

  • Perineal complications

    Daily during hospitalization and at 1, 3, 6, 9 and 12 months after surgery

Study Arms (2)

Arm with biological mesh

EXPERIMENTAL

The intervention consists of perinal reconstruction using biological mesh (Cellis prosthesis from Meccellis Biotech, reference C1015E size 10x15cm)

Procedure: Biological mesh

Arm with primary perineal wound closure

ACTIVE COMPARATOR

The intervention consists of perinal reconstruction by primary perineal wound closure

Procedure: Primary perineal wound closure

Interventions

Biological meshPROCEDURE

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.

Arm with biological mesh
Primary perineal wound closurePROCEDURE

The intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure

Arm with primary perineal wound closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Amiens University Hospital

Amiens, France

NOT YET RECRUITING

Angers University Hospital

Angers, France

NOT YET RECRUITING

Besançon University Hospital

Besançon, France

NOT YET RECRUITING

Bordeaux University Hospital

Bordeaux, France

NOT YET RECRUITING

Caen University Hospital

Caen, France

NOT YET RECRUITING

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

NOT YET RECRUITING

Grenoble University Hospital

Grenoble, France

NOT YET RECRUITING

Centre Oscar Lambret

Lille, France

RECRUITING

CHRU Lille

Lille, France

NOT YET RECRUITING

Lyon University Hospital

Lyon, France

NOT YET RECRUITING

Paoli Calmettes Institut

Marseille, France

NOT YET RECRUITING

Institut de Cancérologie de Lorraine

Nancy, France

NOT YET RECRUITING

Nancy University Hospital

Nancy, France

NOT YET RECRUITING

Nantes University Hospital

Nantes, France

NOT YET RECRUITING

Saint-Antoine Hospital

Paris, France

NOT YET RECRUITING

Rouen University Hospital

Rouen, France

NOT YET RECRUITING

University Hospital of Toulouse

Toulouse, 31059, France

RECRUITING

Related Publications (1)

  • Buscail E, Canivet C, Ghouti L, Kirzin S, Carrere N, Molinier L, Rosillo A, Lauwers-Cances V, Costa N; French Research Group of Rectal Cancer Surgery (GRECCAR Group). Randomised clinical trial for the cost-utility evaluation of two strategies of perineal reconstruction after abdominoperineal resection in the context of anorectal carcinoma: biological mesh repair versus primary perineal wound closure, study protocol for the GRECCAR 9 Study. BMJ Open. 2021 Apr 1;11(4):e043333. doi: 10.1136/bmjopen-2020-043333.

    PMID: 33795299DERIVED

Study Officials

  • Etienne BUSCAIL, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne BUSCAIL, MD

CONTACT

33-561322373buscail.e@chu-toulouse.fr

Cindy CANIVET, CRA

CONTACT

canivet.c@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 22, 2016

Study Start

February 7, 2021

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(17)