Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Loop Ileostomy Closure

Intervention / Treatment
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* Procedure: MESH
* Procedure: NO MESH
* Radiation: Post-operative Imaging
* Radiation: Pre-operative Imaging
* Other: Blood Test and C-reactive protein at 4th day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MESH<br> | Procedure: MESH<br>* 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.<br>* Other names: Mesh : GORE® BIO-A®;Radiation: Post-operative Imaging<br>* Abdominal Tomography 1 year after ileostomy closure<br>Radiation: Pre-operative Imaging<br>* Contrast study is used to ensure the integrity of the distal anastomosis<br>Other: Blood Test and C-reactive protein at 4th day<br>* All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.<br>|
| Active Comparator: NO MESH<br> | Procedure: NO MESH<br>* 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<br>* Other names: Protocol Ileostomy closure;Radiation: Post-operative Imaging<br>* Abdominal Tomography 1 year after ileostomy closure<br>Radiation: Pre-operative Imaging<br>* Contrast study is used to ensure the integrity of the distal anastomosis<br>Other: Blood Test and C-reactive protein at 4th day<br>* All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loop ileostomy, Eventration