Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia

Parastomal Hernia Clinical Trial

Official title:

Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia: A Long Term Case-controlled Prospective Study of Consecutive Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187235
• Other study ID #: Keyhole vs Sugarbaker
• Status: Completed
• Start date: January 1, 1997
• Est. completion date: December 30, 2015

Study information

• Verified date: December 2019
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 30, 2015
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria: None

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Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Procedure:
• Laparascopic repair of parastomal hernia
Laparascopic repair of parastomal hernia

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Recurrence of parastomal hernia	3 years
Secondary	Mesh-related morbidity	Late mesh-related morbidity	3 years
Secondary	Postoperative complications	Early postoperative complication	30 days after surgery