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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04187235
Enrollment
135
Registered
2019-12-05
Start date
1997-01-01
Completion date
2015-12-30
Last updated
2019-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parastomal Hernia

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

Interventions

PROCEDURELaparascopic repair of parastomal hernia

Laparascopic repair of parastomal hernia

Sponsors

Aalborg University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

None \-

Design outcomes

Primary

MeasureTime frameDescription
Recurrence3 yearsRecurrence of parastomal hernia

Secondary

MeasureTime frameDescription
Mesh-related morbidity3 yearsLate mesh-related morbidity
Postoperative complications30 days after surgeryEarly postoperative complication

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026