NCT02226887

Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh

"Prospective Randomized Clinical Trial of Ileostomy Closure Site Hernia and it´s Prophylaxis by Placing an Absorbable Mesh "

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

Experimental: Reinforcement with Absorbable Mesh Closure of the ileostomy closure incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore \& Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1.

Conditions

• Loop Ileostomy Closure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-05-01
• Completion: 2019-06-01
• First posted: 2014-08-27
• Last updated: 2017-04-13

Locations

1 site across 1 country: Spain