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NCT03938688 · ClinicalTrials.gov registry record · NA
Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 325
- Enrollment target
NCT03938688 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 325 participants.
The verdict
NCT03938688, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 325 participants
- Enrollment target
Study Summary
This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. The primary outcome of interest is recurrence measured one year postoperatively as per standard of care at Cleveland Clinic Center for Abdominal Core Health. Hence, recurrence will be measured using either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI). Study population will include all adult patients (18 years or older) undergoing elective open ventral hernia repair of a clean (Wound class I) defect, where the midline fascia can be approximated and mesh will be placed in the retromuscular position. Only a midline approach to hernia repair and hernia widths equal to or less than 20cm measured intraoperatively will be included
Interventions
- PROCEDURE Mesh placement with Transfascial Sutures
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2019-10-21 |
| Est. Completion | 2022-12-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03938688
The ClinicalTrials.gov registry entry for NCT03938688 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mesh placement with Transfascial Sutures is the first listed.
NCT03938688 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03938688 about?
NCT03938688 is a clinical study titled "Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation". This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. The primary outcome of interest is recurrence measured one year postoperatively as per standard of care at Cleve...
What is the current status of trial NCT03938688?
This trial is currently completed. It is a NA study. The enrollment target is 325 participants. The study started on 2019-10-21. Estimated completion is 2022-12-18.
What interventions are being tested in trial NCT03938688?
The interventions under investigation include: Mesh placement with Transfascial Sutures (PROCEDURE).
Who is sponsoring clinical trial NCT03938688?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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