Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia

Completed

• Conditions: Parastomal Hernia
• Interventions: Procedure: Laparascopic repair of parastomal hernia

• Registration Number: NCT04187235
• Lead Sponsor: Aalborg University Hospital

Brief 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

Study Timeline

• Study Start: 1997-01-01
• Primary Completion: 2015-12-30
• Study Completion: 2015-12-30
• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Last Update Submitted: 2019-12-03
• Study First Posted: 2019-12-05
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Patients with a diagnosis of parastomal hernia and indication for surgical treatment -

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Keyhole rapair	Laparascopic repair of parastomal hernia	74 patients who undervent parastomal hernia repair with keyhole technique 1997-2009
Sugarbaker repair	Laparascopic repair of parastomal hernia	61 patients who undervent parastomal henia repair a.m. Sugarbaker 2009-2015

Primary Outcome Measures

Name	Time	Method
Recurrence	3 years	Recurrence of parastomal hernia

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days after surgery	Early postoperative complication
Mesh-related morbidity	3 years	Late mesh-related morbidity

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark