Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh (ILEOCLOSE)

Vall d'Hebron University Hospital (HUVH)

Status and phase: Unknown; Phase 4

Conditions: Loop Ileostomy Closure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02226887

PR(AG)288/2013

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing a loop ileostomy closure

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

MESH

Experimental group

Treatment:

Radiation: Post-operative Imaging

Radiation: Pre-operative Imaging

Other: Blood Test and C-reactive protein at 4th day

Procedure: MESH

NO MESH

Active Comparator group

Treatment:

Procedure: NO MESH

Radiation: Post-operative Imaging

Radiation: Pre-operative Imaging

Other: Blood Test and C-reactive protein at 4th day