Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Design Prospective , randomized, parallel phase IV.
Objectives Main objective
Secondary objectives Comparison of complications(morbidity and mortality) to assess safety and tolerability of the placement of the mesh described .
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MESH | Experimental |
| |
| NO MESH | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MESH | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eventration | Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusive problems | Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),....
| 30 days after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Borja Villanueva Figueredo, MD | Hospital Universitari Vall d'Hebron Research Institute | Principal Investigator |
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Vall d´Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020139 | Gastroschisis |
| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| NO MESH | Procedure |
Post-Op - Hospital discharge after verification of normal digestive transit |
|
|
| Post-operative Imaging | Radiation | Abdominal Tomography 1 year after ileostomy closure |
|
| Pre-operative Imaging | Radiation | Contrast study is used to ensure the integrity of the distal anastomosis |
|
| Blood Test and C-reactive protein at 4th day | Other | All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge. |
|
| Iatrogenic problems |
Damage to structures such as ureters, bowel loops artery / iliac vein ....
|
| 30 days after surgery |
| Impaired healing | Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...
| 30 days after surgery |
| Bleeding problems | Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....
| 30 days after surgery |
| Cardiac complications | acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema
| 30 days after surgery |
| Nephro-urinary complications | Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...
| 30 days after surgery |
| Respiratory complications | Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...
| 30 days after surgery |
| Vascular Complications | Deep venous thrombosis, phlebitis, thrombophlebitis, ...
| 30 days after surgery |
| Gastrointestinal complications | Liver failure, gastrointestinal bleeding, severe malnutrition, ...
| 30 days after surgery |
| Neurological complications | Disorientation, cerebral vascular accident, ...
| 30 days after surgery |
| Local infection | Superficial, deep, body-cavity
| 30 days after surgery |
| Local complications | Hematoma, seroma, evisceration
| 30 days after surgery |
| Hospital stay | Hospital stay since surgery is done | Days |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |