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Completed

NCT Number: NCT04187235

Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia

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.

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Key information

Conditions

Parastomal Hernia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

-

Treatment and study plan

Laparascopic repair of parastomal hernia

Procedure

Laparascopic repair of parastomal hernia

Primary outcomes

  1. Recurrence

    Time frame: 3 years

    Recurrence of parastomal hernia

Secondary outcomes

  1. Mesh-related morbidity

    Time frame: 3 years

    Late mesh-related morbidity

  2. Postoperative complications

    Time frame: 30 days after surgery

    Early postoperative complication

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2019
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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