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.

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.

Study Overview

• Status: Completed
• Conditions: Parastomal Hernia
• Intervention / Treatment: Procedure: Laparascopic repair of parastomal hernia

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 Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with parastomal hernia referred to Aarhus University Hospital

Description

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

Exclusion Criteria: None

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Keyhole rapair; 74 patients who undervent parastomal hernia repair with keyhole technique 1997-2009	Procedure: Laparascopic repair of parastomal hernia; Laparascopic repair of parastomal hernia
Sugarbaker repair; 61 patients who undervent parastomal henia repair a.m. Sugarbaker 2009-2015	Procedure: Laparascopic repair of parastomal hernia; Laparascopic repair of parastomal hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence	Recurrence of parastomal hernia	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesh-related morbidity	Late mesh-related morbidity	3 years
Postoperative complications	Early postoperative complication	30 days after surgery

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Study Chair: Paul Wara, DMSc, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1997
• Primary Completion (Actual): December 30, 2015
• Study Completion (Actual): December 30, 2015

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: Keyhole vs Sugarbaker

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We have no permission to share individual participant data with 3rd parties

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No