Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138957
Status:
WITHDRAWN
Last Update Posted:
2008-07-11
First Post:
2005-08-29
Brief Title:
Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh
Sponsor:
University Hospital Gentofte Copenhagen
Organization:
University Hospital Gentofte Copenhagen
Study Overview
Official Title:
Laparoscopic Parastomal Hernia Repair Using an Innovative Composite Polypropylene Mesh - A Prospective Study
Status:
WITHDRAWN
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
too few patients included
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh looking at postoperative complications recurrence rate and postoperative pain and quality of life
Detailed Description:
Parastomal hernia affects up to 50 of all patients following formation of a stoma most often in patients with a colostomy About 20 of the patients need surgical correction of their parastomal hernia Symptoms associated with parastomal hernias goes from mild physical pain and cosmetic discomfort to life threatening conditions with obstruction strangulation and perforation Parastomal hernias have big socioeconomic consequences and remain a considerable clinical problem
The surgical treatment of parastomal hernias is controversial The best way to treat it is to restore the continuity of the intestine but in permanent stomas this is not an option Many surgical techniques have been described when intervention is required but the results are unacceptable The traditional open techniques are local simple suturing of the fascia defect stoma relocation or repair with a prosthetic material either intraperitoneally or extraperitoneally subfascial or onlay Overall the results of all methods are poor with high recurrence rates and high morbidity and mortality Mesh repair has the lowest recurrence rate 0-39 and stoma relocation and simple suture has reported recurrence rates on 0-76 and 46-100 respectively Laparoscopic repair of parastomal hernias with a prosthetic mesh inserted intraperitoneally is a new method described in a few small series The results so far are encouraging but the follow-up period is short
Looking at the disappointing results from the traditional open techniques in the treatment of parastomal hernias together with the enormous success in laparoscopic ventral hernia repair and laparoscopy overall we believe that laparoscopic parastomal hernia repair with mesh will be an effective treatment option in the future Therefore we find it interesting to investigate the technique in a prospective study
The surgical treatment of parastomal hernias is controversial The best way to treat it is to restore the continuity of the intestine but in permanent stomas this is not an option Many surgical techniques have been described when intervention is required but the results are unacceptable The traditional open techniques are local simple suturing of the fascia defect stoma relocation or repair with a prosthetic material either intraperitoneally or extraperitoneally subfascial or onlay Overall the results of all methods are poor with high recurrence rates and high morbidity and mortality Mesh repair has the lowest recurrence rate 0-39 and stoma relocation and simple suture has reported recurrence rates on 0-76 and 46-100 respectively Laparoscopic repair of parastomal hernias with a prosthetic mesh inserted intraperitoneally is a new method described in a few small series The results so far are encouraging but the follow-up period is short
Looking at the disappointing results from the traditional open techniques in the treatment of parastomal hernias together with the enormous success in laparoscopic ventral hernia repair and laparoscopy overall we believe that laparoscopic parastomal hernia repair with mesh will be an effective treatment option in the future Therefore we find it interesting to investigate the technique in a prospective study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None