Parastomal Hernia Clinical Trial
Official title:
Randomized Double-blind Study on the Use of Resorbable Prosthetic Mesh "Ante Rectus" as a Prevention of Parastomal Hernia in Patients Undergoing Terminal Colostomy
The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.
Several surgical scenarios include colon diversion as part of their management. Among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, Inflammatory Bowel Disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. Colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. Parastomal Hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by Computer Tomography. Although Parastomal Hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' Quality of Life. Several surgical options are available for Parastomal Hernia repair, many of them supporting the use of mesh to strengthen the fascia. However, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. Several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia. The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT05514600 -
Fascial Defect Closure for Minimally Invasive Parastomal Hernia Repair
|
N/A | |
| Recruiting |
NCT04311333 -
Endostomal Three-dimensional Ultrasonography for Parastomal Hernia
|
N/A | |
| Not yet recruiting |
NCT06077318 -
Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia
|
||
| Completed |
NCT01380860 -
Primary Prevention of Peristomial Hernias Via Parietal Prostheses
|
N/A | |
| Completed |
NCT00908661 -
Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia
|
N/A | |
| Recruiting |
NCT04282473 -
Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
|
||
| Completed |
NCT03792243 -
Outcomes After Parastomal Hernia Repair
|
||
| Recruiting |
NCT01955278 -
Role of Prosthetic Mesh in Preventing Parastomal Hernias
|
Phase 3 | |
| Terminated |
NCT00641342 -
Prevention of Parastomal Hernia by Primary Mesh Insertion
|
Phase 2/Phase 3 | |
| Terminated |
NCT04966065 -
Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies
|
||
| Recruiting |
NCT04440514 -
Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)
|
||
| Not yet recruiting |
NCT04950140 -
Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
|
N/A | |
| Terminated |
NCT02489175 -
Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia
|
N/A | |
| Recruiting |
NCT03667287 -
Stoma Hernia Intraperitoneal Full-Thickness Skin
|
N/A | |
| Completed |
NCT01722565 -
Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
|
Phase 4 | |
| Completed |
NCT02368873 -
the Use of a IPOM Mesh for Prevention of Parastomal Hernia
|
N/A | |
| Completed |
NCT02233465 -
Treating Parastomal Hernia With a Mesh
|
Phase 1/Phase 2 | |
| Completed |
NCT00917995 -
Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
|
Phase 2/Phase 3 | |
| Completed |
NCT01484743 -
Risk Factors for Morbidity After Parastomal Hernia Repair
|
||
| Completed |
NCT00509054 -
Prevention of Parastomal Hernia With a Mesh
|
Phase 4 |