Clinical Trials Directory

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

TypeNameDescription
PROCEDURELaparascopic repair of parastomal herniaLaparascopic 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.