Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh
NCT ID: NCT02226887
Last Updated: 2017-04-13
Study Results
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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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2014-04-30
2019-06-30
Brief Summary
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Objectives Main objective
* Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of incisional hernia of the abdominal wall at the site of a loop ileostomy when it is "closed " to rebuild the intestinal transit. The effectiveness evaluation is done by tracking with scheduled patient visits for 12 months, assessing the physical examination the presence or absence of an incisional hernia and an abdominal tomography at the end of the 12 months .
Secondary objectives Comparison of complications(morbidity and mortality) to assess safety and tolerability of the placement of the mesh described .
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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MESH
MESH
1. Pre-operative :
It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
2. Surgical technique:
* Peristomal incision with electrocautery
* Release the handle of ileum
* Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
* Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
* We add the mesh between the edges of the defect during fascia closure.
* The skin is sutured "purse string" style.
3. Post-Op
* Hospital discharge after verification of normal digestive transit.
Post-operative Imaging
Abdominal Tomography 1 year after ileostomy closure
Pre-operative Imaging
Contrast study is used to ensure the integrity of the distal anastomosis
Blood Test and C-reactive protein at 4th day
All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.
NO MESH
NO MESH
1. Pre-operative :
It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
2. Surgical technique:
* Peristomal incision with electrocautery
* Release the handle of ileum
* Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
* Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
* The skin is sutured "purse string" style.
Post-Op
\- Hospital discharge after verification of normal digestive transit
Post-operative Imaging
Abdominal Tomography 1 year after ileostomy closure
Pre-operative Imaging
Contrast study is used to ensure the integrity of the distal anastomosis
Blood Test and C-reactive protein at 4th day
All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.
Interventions
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MESH
1. Pre-operative :
It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
2. Surgical technique:
* Peristomal incision with electrocautery
* Release the handle of ileum
* Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
* Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
* We add the mesh between the edges of the defect during fascia closure.
* The skin is sutured "purse string" style.
3. Post-Op
* Hospital discharge after verification of normal digestive transit.
NO MESH
1. Pre-operative :
It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
2. Surgical technique:
* Peristomal incision with electrocautery
* Release the handle of ileum
* Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
* Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
* The skin is sutured "purse string" style.
Post-Op
\- Hospital discharge after verification of normal digestive transit
Post-operative Imaging
Abdominal Tomography 1 year after ileostomy closure
Pre-operative Imaging
Contrast study is used to ensure the integrity of the distal anastomosis
Blood Test and C-reactive protein at 4th day
All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy and Lactation
* Patients allergic to polyglycolic / trimethylene carbonate
* Carrier of prosthetic mesh in the ostomy
* Patients presenting midline hernia.
* Patients affected by inflammatory bowel disease
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Borja Villanueva Figueredo, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Vall d'Hebron Research Institute
Francesc Vallribera Valls, MD,PhD
Role: STUDY_DIRECTOR
Hospital Universitari Vall d'Hebron Research Institute
Manuel Lopez-Cano, MD, PhD
Role: STUDY_DIRECTOR
Hospital Universitari Vall d'Hebron Research Institute
Locations
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Hospital General Universitario Vall d´Hebron
Barcelona, Barcelona, Spain
Countries
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Facility Contacts
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Other Identifiers
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PR(AG)288/2013
Identifier Type: -
Identifier Source: org_study_id
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