Clinical trial NCT02226887: Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh
Official title: "Prospective Randomized Clinical Trial of Ileostomy Closure Site Hernia and it´s Prophylaxis by Placing an Absorbable Mesh "
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Loop Ileostomy Closure
Keywords: Loop ileostomy
Eventration
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Eventration
timeFrame: 1 year
Secondary outcomes:
measure: Occlusive problems
timeFrame: 30 days after surgery
measure: Iatrogenic problems
timeFrame: 30 days after surgery
measure: Impaired healing
timeFrame: 30 days after surgery
measure: Bleeding problems
timeFrame: 30 days after surgery
measure: Cardiac complications
timeFrame: 30 days after surgery
measure: Nephro-urinary complications
timeFrame: 30 days after surgery
measure: Respiratory complications
timeFrame: 30 days after surgery
measure: Vascular Complications
timeFrame: 30 days after surgery
measure: Gastrointestinal complications
timeFrame: 30 days after surgery
measure: Neurological complications
timeFrame: 30 days after surgery
measure: Local infection
timeFrame: 30 days after surgery
measure: Local complications
timeFrame: 30 days after surgery
measure: Hospital stay
timeFrame: Days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall d´Hebron
Study officials:
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Borja Villanueva Figueredo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Francesc Vallribera Valls, MD,PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Manuel Lopez-Cano, MD, PhD
role: STUDY_DIRECTOR
References: