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Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery

NCT ID: NCT02576184

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-11-15

Brief Summary

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This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

Detailed Description

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This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.

Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.

Conditions

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Incisional Hernia After Diverting Stoma Closure

Keywords

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Incisional hernia Stoma rectal cancer synthetic mesh biologic mesh

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Biologic mesh Synthetic mesh
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Biologic Mesh

Biologic mesh placed in retromuscular position

Group Type EXPERIMENTAL

Biologic Mesh

Intervention Type DEVICE

Biologic mesh placed in retromuscular position during ileostoma closure

Synthetic Mesh

Synthetic mesh placed in retromuscular position

Group Type EXPERIMENTAL

Synthetic Mesh

Intervention Type DEVICE

synthetic mesh placed in retromuscular position during ileostoma closure

No Mesh

No mesh

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Biologic Mesh

Biologic mesh placed in retromuscular position during ileostoma closure

Intervention Type DEVICE

Synthetic Mesh

synthetic mesh placed in retromuscular position during ileostoma closure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery
* Signed consent
* Affiliation to the French social security system

Exclusion Criteria

* Emergency surgery
* History of laparotomy before ileostoma closure.
* Surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy
* Lactating or pregnant woman
* Allergy to porcine product or collagen-based product. Allergy to polypropylene.
* Participation to another protocol focusing on ileostoma closure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leon Maggiori, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service de Chirurgie Colorectale - Hôpital Beaujon

Clichy, , France

Site Status

Countries

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France

References

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Vu BK, Lam J, Sherman MJ, Tam MS. Prophylactic Biosynthetic Retrorectus Mesh Placement During Stoma Reversal Reduces the Rate of Stoma Site Incisional Hernia. Perm J. 2024 Jun 14;28(2):16-25. doi: 10.7812/TPP/23.115. Epub 2024 Apr 23.

Reference Type DERIVED
PMID: 38652519 (View on PubMed)

Other Identifiers

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2015-A00410-49

Identifier Type: OTHER

Identifier Source: secondary_id

P140312

Identifier Type: -

Identifier Source: org_study_id