UnknownPhase 4

Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh

Spain120 participantsStarted 2014-04

Plain-language 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 .

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Eventration

Timeframe: 1 year

Trial details

NCT IDNCT02226887

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05

View on ClinicalTrials.gov More Loop Ileostomy Closure trials