Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques

Completed · Not applicable

Conditions studied: Parastomal Hernia

In brief

This will be a randomized controlled trial comparing the incidence of radiographic hernia recurrence 2 years after parastomal hernia repair utilizing the retro-muscular Sugarbaker technique compared to the retro-muscular keyhole mesh technique. The primary endpoint will be recurrence at two years. Secondary endpoints will be the incidence of mesh-related complications, all 30-day complication rates, and hospital length of stay. Patients eligible for the study will be 18 years or older with a parastomal hernia that requires open repair retromuscular repair without ostomy reversal as determined by one of five hernia surgeons who will participate in this study at the investigators' institution. All patients will be marked for a new stoma site preoperatively. Patients who have insufficient bowel length suitable for either technique will be excluded intraoperatively. Patients enrolled in the study will be entered in the Americas Hernia Society Quality Collaborative database by the attending surgeon. The database houses patient demographics, medical comorbidities, operative details, and postoperative outcomes - all entered by the attending surgeon.

Key facts

Study ID

NCT03972553

Run by

Clayton Petro

People needed

150

Starts

2019-04-25

Expected to finish

2023-11-27

Last updated by the study team

2023-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is willing and able to give informed consent
• Patient has one parastomal hernia
• Patient is willing to undergo mesh-based repair
• Patient is considered eligible to undergo open retromuscular repair without ostomy reversal
• The patient can tolerate general anesthesia
• Repair being performed in an elective situation

You may not qualify if…

• The subject is <18 years of age
• Patient has more than one stoma
• The patient is unable to give informed consent
• Patient is not willing to undergo mesh-based repair due to any reason
• Patient not eligible for open retromuscular repair without ostomy reversal
• Patient is unable to tolerate general anesthesia

Where it is running

• Cleveland Clinic Center for Abdominal Core Health — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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