Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh

Phase 4

• Conditions: Loop Ileostomy Closure
• Interventions: Procedure: MESH; Procedure: NO MESH; Radiation: Post-operative Imaging; Radiation: Pre-operative Imaging; Other: Blood Test and C-reactive protein at 4th day

• Registration Number: NCT02226887
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study First Submitted: 2014-03-18
• Study Start: 2014-04
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-27
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13
• Primary Completion: 2018-05
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NO MESH	Post-operative Imaging	-
NO MESH	Pre-operative Imaging	-
MESH	Pre-operative Imaging	-
MESH	MESH	-
MESH	Post-operative Imaging	-
MESH	Blood Test and C-reactive protein at 4th day	-
NO MESH	Blood Test and C-reactive protein at 4th day	-
NO MESH	NO MESH	-

Primary Outcome Measures

Name	Time	Method
Eventration	1 year	Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.

Secondary Outcome Measures

Name	Time	Method
Iatrogenic problems	30 days after surgery	Damage to structures such as ureters, bowel loops artery / iliac vein ....; * This is a Surgical and Clinical measure supported by image if necessary.; * All the morbidity problems are reported independently.
Cardiac complications	30 days after surgery	acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema; * This is a Clinical measure supported by more specific tests if necessary.; * All the morbidity problems are reported independently.; * Cardiologist report will be required for including this items
Gastrointestinal complications	30 days after surgery	Liver failure, gastrointestinal bleeding, severe malnutrition, ...; * This is a Clinical measure supported by blood test and further test if necessary; * All the morbidity problems are reported independently.
Local complications	30 days after surgery	Hematoma, seroma, evisceration; * This is a Clinical measure; * All the morbidity problems are reported independently
Occlusive problems	30 days after surgery	Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(\>5days),....; * This is a Clinical measure supported by image if necessary; * All the morbidity problems are reported independently.; * 1 patient can suffer a prolonged ileus and Anastomotic stenosis and both will be reported.
Bleeding problems	30 days after surgery	Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....; * This is a Clinical measure supported by image if necessary.; * All the morbidity problems are reported independently.; * The amount of blood loss won't be specified
Nephro-urinary complications	30 days after surgery	Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...; * This is a Clinical measure supported by more specific tests if necessary.; * All the morbidity problems are reported independently.
Impaired healing	30 days after surgery	Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...; * This is a Clinical measure always supported by image tests.; * All the morbidity problems are reported independently.
Neurological complications	30 days after surgery	Disorientation, cerebral vascular accident, ...; * This is a Clinical measure.; * All the morbidity problems are reported independently.; * Neurologist report will be required beyond disorientation.
Respiratory complications	30 days after surgery	Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...; * This is a Clinical measure always supported by image .; * All the morbidity problems are reported independently.
Vascular Complications	30 days after surgery	Deep venous thrombosis, phlebitis, thrombophlebitis, ...; * This is a Clinical measure supported by more specific test if necessary .; * All the morbidity problems are reported independently
Local infection	30 days after surgery	Superficial, deep, body-cavity; * This is a Clinical measure supported by image if necessary; * All the morbidity problems are reported independently
Hospital stay	Days	Hospital stay since surgery is done

Trial Locations

Locations (1)

Hospital General Universitario Vall d´Hebron; 🇪🇸 Barcelona, Spain