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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04187235
Other study ID # Keyhole vs Sugarbaker
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

-

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT02368873 - the Use of a IPOM Mesh for Prevention of Parastomal Hernia N/A
Completed NCT02233465 - Treating Parastomal Hernia With a Mesh Phase 1/Phase 2
Completed NCT00917995 - Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh Phase 2/Phase 3
Completed NCT01484743 - Risk Factors for Morbidity After Parastomal Hernia Repair
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