Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh

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

Interventions

PROCEDURE

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.

PROCEDURE

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

RADIATION

Post-operative Imaging

Abdominal Tomography 1 year after ileostomy closure

RADIATION

Pre-operative Imaging

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

OTHER

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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Borja Villanueva Figueredo, MD · Hospital Universitari Vall d'Hebron Research Institute

• Francesc Vallribera Valls, MD,PhD · Hospital Universitari Vall d'Hebron Research Institute

• Manuel Lopez-Cano, MD, PhD · Hospital Universitari Vall d'Hebron Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2018-05-31

Completion

2019-06-30

Countries

• Spain

Study Locations