Mesh Reinforcement During Temporary Stoma Closure After S... | NCT02576184

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

NCT02576184

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 22, 2021Actual

Enrollment

381Actual

Phase

Not Applicable

Conditions

Incisional Hernia After Diverting Stoma Closure

Interventions

Biologic Mesh
Synthetic Mesh

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-A00410-49	Other Identifier	IDRCB

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Nov 15, 2020Actual

Completion Date

Nov 15, 2020Actual

First Submitted Date

Oct 5, 2015

First Submission Date that Met QC Criteria

Oct 14, 2015

First Posted Date

Oct 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2021

Last Update Posted Date

Nov 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

381Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Biologic Mesh	Device	Biologic mesh placed in retromuscular position during ileostoma closure	Biologic Mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Postoperative morbidity	Postoperative morbidity	30 days
Postoperative pain	Score Brief Pain Inventory	36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leon Maggiori, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie Colorectale - Hôpital Beaujon		Clichy		92118	France

Condition Browse Module

MeSH Terms

ID	Term
D000069290	Incisional Hernia
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

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Browse Branches

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