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

"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 .

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital General Universitario Vall d´Hebron
    • Contact: Borja Villanueva, MD; Phone Number: +34 629801238; Email: b.villanueva@hotmail.com
    • Principal Investigator: Borja Villanueva Figueredo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MESH	Procedure: MESH; Pre-operative :It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .; Surgical technique:Peristomal incision with electrocauteryRelease the handle of ileumAnastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.We add the mesh between the edges of the defect during fascia closure.The skin is sutured "purse string" style.; Post-OpHospital discharge after verification of normal digestive transit.; Other Names: Mesh : GORE® BIO-A®; Radiation: Post-operative Imaging; Abdominal Tomography 1 year after ileostomy closure; Radiation: Pre-operative Imaging; Contrast study is used to ensure the integrity of the distal anastomosis; Other: Blood Test and C-reactive protein at 4th day; All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.
Active Comparator: NO MESH	Radiation: Post-operative Imaging; Abdominal Tomography 1 year after ileostomy closure; Radiation: Pre-operative Imaging; Contrast study is used to ensure the integrity of the distal anastomosis; Other: Blood Test and C-reactive protein at 4th day; All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.; Procedure: NO MESH; Pre-operative :It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .; Surgical technique:Peristomal incision with electrocauteryRelease the handle of ileumAnastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.The skin is sutured "purse string" style. Post-Op - Hospital discharge after verification of normal digestive transit; Other Names: Protocol Ileostomy closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eventration	Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusive problems	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.	30 days after surgery
Iatrogenic problems	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.	30 days after surgery
Impaired healing	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.	30 days after surgery
Bleeding problems	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	30 days after surgery
Cardiac complications	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	30 days after surgery
Nephro-urinary complications	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.	30 days after surgery
Respiratory complications	Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...; This is a Clinical measure always supported by image .; All the morbidity problems are reported independently.	30 days after surgery
Vascular Complications	Deep venous thrombosis, phlebitis, thrombophlebitis, ...; This is a Clinical measure supported by more specific test if necessary .; All the morbidity problems are reported independently	30 days after surgery
Gastrointestinal complications	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.	30 days after surgery
Neurological complications	Disorientation, cerebral vascular accident, ...; This is a Clinical measure.; All the morbidity problems are reported independently.; Neurologist report will be required beyond disorientation.	30 days after surgery
Local infection	Superficial, deep, body-cavity; This is a Clinical measure supported by image if necessary; All the morbidity problems are reported independently	30 days after surgery
Local complications	Hematoma, seroma, evisceration; This is a Clinical measure; All the morbidity problems are reported independently	30 days after surgery
Hospital stay	Hospital stay since surgery is done	Days

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Borja Villanueva Figueredo, MD, Hospital Universitari Vall d'Hebron Research Institute; Study Director: Francesc Vallribera Valls, MD,PhD, Hospital Universitari Vall d'Hebron Research Institute; Study Director: Manuel Lopez-Cano, MD, PhD, Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Eventration; Loop ileostomy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: PR(AG)288/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO