Parastomal Hernia Clinical Trial
Official title:
Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia
This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.
Parastomal hernia is a common complication to a stoma which can cause considerable suffering
for the patient. The conventional methods of repair available today have disappointing
results with high recurrence rates and serious complications. Some of the complications can
be related to the introduction of foreign material into the abdominal wall. The investigators
hypothesis is that the use of autologous full-thickness skin graft as reinforcement material
can offer an alternative with fewer complications and recurrences.
Patients with symptomatic parastomal hernia will be included in a prospective randomized
multicenter study comparing reinforcement with conventional synthetic mesh (with the best
available technique today), to full thickness skin grafts placed in an intraperitoneal
position. The intervention will be blinded to the participants, nursing staff and the
follow-up staff. The participants will be followed up at 3, 12 and 36 months monitoring
complications, recurrences, quality of life, strength of the abdomino-lumbar girdle and
calculations will be done on the health economics.
;
| 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 | |
| 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 | |
| Completed |
NCT04187235 -
Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia
|