Loop Ileostomy Closure Clinical Trial
Official title:
"Prospective Randomized Clinical Trial of Ileostomy Closure Site Hernia and it´s Prophylaxis by Placing an Absorbable Mesh "
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 .
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. ;