Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh

NCT02226887 | Unknown Phase 4

• 1 other identifier: PR(AG)288/2013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Design Prospective , randomized, parallel phase IV. 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 .

Conditions

Loop Ileostomy Closure

Keywords

Loop ileostomy; Eventration

Outcome Measures

Primary Outcomes (1)

• Eventration

  Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.

  1 year

Secondary Outcomes (13)

• Occlusive problems

  30 days after surgery

• Iatrogenic problems

  30 days after surgery

• Impaired healing

  30 days after surgery

• Bleeding problems

  30 days after surgery

• Cardiac complications

  30 days after surgery

Study Arms (2)

MESH

EXPERIMENTAL

Procedure: MESH; Radiation: Post-operative Imaging; Radiation: Pre-operative Imaging; Other: Blood Test and C-reactive protein at 4th day

NO MESH

ACTIVE COMPARATOR

Procedure: NO MESH; Radiation: Post-operative Imaging; Radiation: Pre-operative Imaging; Other: Blood Test and C-reactive protein at 4th day

Interventions

MESH PROCEDURE

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.

Also known as: Mesh : GORE® BIO-A®

MESH

NO MESH PROCEDURE

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

Also known as: Protocol Ileostomy closure

NO MESH

Post-operative Imaging RADIATION

Abdominal Tomography 1 year after ileostomy closure

MESH; NO MESH

Pre-operative Imaging RADIATION

Contrast study is used to ensure the integrity of the distal anastomosis

MESH; NO MESH

Blood Test and C-reactive protein at 4th day OTHER

All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.

MESH; NO MESH

Eligibility Criteria

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

You may qualify if:

• Patients undergoing a loop ileostomy closure

You may not qualify if:

• Patients under 18
• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital General Universitario Vall d´Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Gastroschisis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Borja Villanueva Figueredo, MD

  Hospital Universitari Vall d'Hebron Research Institute

  PRINCIPAL INVESTIGATOR

• Francesc Vallribera Valls, MD,PhD

  Hospital Universitari Vall d'Hebron Research Institute

  STUDY DIRECTOR

• Manuel Lopez-Cano, MD, PhD

  Hospital Universitari Vall d'Hebron Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: August 27, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2019
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)