Parastomal Hernia Clinical Trial
Official title:
Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the
many prevention and treatment techniques that have been described. Since the introduction of
laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia
remains a surgical problem of considerable importance, requiring significant consumption of
public health and economic resources, and representing a major alteration of the quality of
life of these patients.
Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in
elective surgery for laparoscopic abdominoperineal resection.
Methodology: prospective, multidisciplinary, multi-center randomized controlled study.
Control group: Rectal neoplasms undergoing elective surgery for laparoscopic
abdominoperineal resection. Study group: Rectal neoplasms undergoing elective surgery for
laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and
poliglecaprone 25). Sample size was calculated based on a proportion of parastomal hernia of
65% in the control group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28
patients are required, 14 per group. Estimating a drop-out rate of 10%, the final number
will be 32 patients. The efficacy will be evaluated clinically at six months and abdominal
CT will be performed at 12 months along with another clinical evaluation.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| 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 |
NCT02368873 -
the Use of a IPOM Mesh for Prevention of Parastomal Hernia
|
N/A | |
| Completed |
NCT00917995 -
Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
|
Phase 2/Phase 3 | |
| Completed |
NCT02233465 -
Treating Parastomal Hernia With a Mesh
|
Phase 1/Phase 2 | |
| 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
|