Loop Ileostomy Closure
Conditions
Keywords
Loop ileostomy, Eventration
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.
Interventions
PROCEDUREMESH
1. Pre-operative : It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure . 2. 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. 3. Post-Op * Hospital discharge after verification of normal digestive transit.
PROCEDURENO MESH
1. Pre-operative : It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure . 2. 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
RADIATIONPost-operative Imaging
Abdominal Tomography 1 year after ileostomy closure
RADIATIONPre-operative Imaging
Contrast study is used to ensure the integrity of the distal anastomosis
OTHERBlood 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.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eventration | 1 year | Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| Local complications | 30 days after surgery | Hematoma, seroma, evisceration * This is a Clinical measure * All the morbidity problems are reported independently |
| Hospital stay | Days | Hospital stay since surgery is done |
| 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 |
Countries
Spain
Outcome results
None listed