Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh

Loop Ileostomy Closure Clinical Trial

— ILEOCLOSE  

Official title:

"Prospective Randomized Clinical Trial of Ileostomy Closure Site Hernia and it´s Prophylaxis by Placing an Absorbable Mesh "

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02226887
• Other study ID #: PR(AG)288/2013
• Status: Recruiting
• Phase: Phase 4
• First received: March 18, 2014
• Last updated: April 11, 2017
• Start date: April 2014
• Est. completion date: June 2019

Study information

• Verified date: April 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Loop Ileostomy Closure

Intervention

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 electrocautery Release the handle of ileum Anastomosis 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-Op Hospital discharge after verification of normal digestive transit.
• 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 electrocautery Release the handle of ileum Anastomosis 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

Radiation:
• Post-operative Imaging
Abdominal Tomography 1 year after ileostomy closure
• 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.

Locations

Country	Name	City	State
Spain	Hospital General Universitario Vall d´Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eventration	Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Local complications	Hematoma, seroma, evisceration; This is a Clinical measure; All the morbidity problems are reported independently	30 days after surgery
Secondary	Hospital stay	Hospital stay since surgery is done	Days