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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576184
Recruitment Status : Unknown
Verified April 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : October 15, 2015
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Incisional Hernia After Diverting Stoma Closure Device: Biologic Mesh Device: Synthetic Mesh Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Biologic Mesh
Biologic mesh placed in retromuscular position
Device: Biologic Mesh
Biologic mesh placed in retromuscular position during ileostoma closure

Experimental: Synthetic Mesh
Synthetic mesh placed in retromuscular position
Device: Synthetic Mesh
synthetic mesh placed in retromuscular position during ileostoma closure

No Intervention: No Mesh
No mesh



Primary Outcome Measures :
  1. radiological incisional hernia rate [ Time Frame: up to 36 months ]

    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



Secondary Outcome Measures :
  1. Postoperative morbidity [ Time Frame: 30 days ]
  2. Postoperative pain [ Time Frame: 36 months ]
    Score Brief Pain Inventory

  3. Postoperative rehospitalization [ Time Frame: 36 months ]
    Case report form data

  4. Postoperative reintervention [ Time Frame: 36 months ]
    Case report form data

  5. Quality of life [ Time Frame: 12 months ]
    SF36

  6. Clinical incisional hernia rate [ Time Frame: 36 months ]
    Clinical incisional hernia rate : Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576184


Contacts
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Contact: Leon Maggiori, MD 33 1.40.87.45.47 leon.maggiori@aphp.fr

Locations
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France
Service de Chirurgie Colorectale - Hôpital Beaujon Recruiting
Clichy, France, 92118
Contact: Léon MAGGIORI, MD    33 1.40.87.45.47    leon.maggiori@bjn.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Leon Maggiori, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02576184    
Other Study ID Numbers: P140312
2015-A00410-49 ( Other Identifier: IDRCB )
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Incisional hernia
Stoma
rectal cancer
synthetic mesh
biologic mesh
Additional relevant MeSH terms:
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Rectal Neoplasms
Hernia
Incisional Hernia
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes