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NCT03972553 · ClinicalTrials.gov registry record · NA
Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques
A NA study, sponsored by Clayton Petro.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT03972553 is a NA study that has completed, run by Clayton Petro. The registered enrollment target is 150 participants.
The verdict
NCT03972553, a NA study, has completed, sponsored by Clayton Petro.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
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.
Interventions
- PROCEDURE Sugarbaker technique for repairing parastomal hernia
- PROCEDURE Keyhole technique for repairing parastomal hernia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-04-25 |
| Est. Completion | 2023-11-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03972553
The ClinicalTrials.gov registry entry for NCT03972553 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clayton Petro, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sugarbaker technique for repairing parastomal hernia is the first listed.
NCT03972553 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03972553 about?
NCT03972553 is a clinical study titled "Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques". 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. S...
What is the current status of trial NCT03972553?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2019-04-25. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT03972553?
The interventions under investigation include: Sugarbaker technique for repairing parastomal hernia (PROCEDURE), Keyhole technique for repairing parastomal hernia (PROCEDURE).
Who is sponsoring clinical trial NCT03972553?
This trial is sponsored by Clayton Petro, which has 5 total clinical trials registered on ClinicalTrials.gov.
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