Trials / Completed
CompletedNCT04187235
Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia
Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia: A Long Term Case-controlled Prospective Study of Consecutive Patients.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 135 (actual)
- Sponsor
- Aalborg University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.
Detailed description
Objective: To compare the laparoscopic Keyhole repair with the modified Sugarbaker repair in a nonrandomised case-controlled prospective study of consecutive patients with parastomal hernia. Summary Background Data: Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim. Methods: In two time periods 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and ePTFE with a self-cut slit, 1997- 2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009-2015). The patients in the two groups matched with regard to age, gender, ASA score, colostomy or ileostomy hernia, previous repairs, size of fascial defect and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma re-siting, mesh removal, death, or last non-event visit
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Laparascopic repair of parastomal hernia | Laparascopic repair of parastomal hernia |
Timeline
- Start date
- 1997-01-01
- Primary completion
- 2015-12-30
- Completion
- 2015-12-30
- First posted
- 2019-12-05
- Last updated
- 2019-12-05
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04187235. Inclusion in this directory is not an endorsement.