Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00641342
Other study ID # PMPC
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received March 18, 2008
Last updated February 6, 2014
Start date March 2007
Est. completion date February 2015

Study information

Verified date March 2008
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial Summary

Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.


Recruitment information / eligibility

Status Terminated
Enrollment 198
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.

Exclusion Criteria:

- ASA > 3

- Acute surgery

- Known immune deficiency

- Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.

- Pregnancy

- Known inflammatory bowel disease

- Lack of written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
onlay mesh
StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)

Locations

Country Name City State
Denmark Copenhagen University Hospital, Gentofte Hellerup Copenhagen
Denmark Copenhagen University Hospital, Hvidovre Hvidovre Copebhagen

Sponsors (8)

Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen Aarhus University Hospital, Copenhagen University Hospital at Herlev, Hillerod Hospital, Denmark, Hvidovre University Hospital, Roskilde County Hospital, Sydvestjysk Hospital, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parastomal hernia verified by CT-scan one year after surgery, reassessed after 2, 3 and 5 years No
Secondary Clinically detected parastomal hernia one year after surgery, reassessed after 2, 3 and 5 years No
Secondary Pain one year after surgery, reassessed after 2, 3 and 5 years No
Secondary Disease specific and general health questionnaire one year after surgery, reassessed after 2, 3 and 5 years No
See also
  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 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 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