Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques
Public ClinicalTrials.gov record NCT03972553. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques: A Registry-Based Randomized Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03972553
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Interventions
- Sugarbaker technique for repairing parastomal hernia Procedure
- Keyhole technique for repairing parastomal hernia Procedure
Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 24, 2019
- Primary completion
- Nov 26, 2023
- Completion
- Nov 26, 2023
- Last update posted
- Dec 3, 2023
2019 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic Center for Abdominal Core Health | Cleveland | Ohio | 44195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03972553, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 3, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03972553 live on ClinicalTrials.gov.