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

NCT02576184 | Completed

• 2 other identifiers: P1403122015-A00410-49
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Incisional Hernia After Diverting Stoma Closure

Keywords

Incisional hernia; Stoma; rectal cancer; synthetic mesh; biologic mesh

Outcome Measures

Primary Outcomes (1)

• radiological incisional hernia rate

  Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up. Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient

  up to 36 months

Secondary Outcomes (6)

• Postoperative morbidity

  30 days

• Postoperative pain

  36 months

• Postoperative rehospitalization

  36 months

• Postoperative reintervention

  36 months

• Quality of life (The Short Form (36) Health Survey score)

  12 months

Study Arms (3)

Biologic Mesh

EXPERIMENTAL

Biologic mesh placed in retromuscular position

Device: Biologic Mesh

Synthetic Mesh

EXPERIMENTAL

Synthetic mesh placed in retromuscular position

Device: Synthetic Mesh

No Mesh

NO INTERVENTION

No mesh

Interventions

Biologic Mesh DEVICE

Biologic mesh placed in retromuscular position during ileostoma closure

Biologic Mesh

Synthetic Mesh DEVICE

synthetic mesh placed in retromuscular position during ileostoma closure

Synthetic Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Chirurgie Colorectale - Hôpital Beaujon

Clichy, 92118, France

Location

Related Publications (1)

• 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.

  PMID: 38652519 DERIVED

MeSH Terms

Conditions

Incisional Hernia; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Leon Maggiori, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Biologic mesh Synthetic mesh

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 15, 2015
• Study Start: December 1, 2015
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

FR (1)