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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: Completed NA study, sponsored by The Cleveland Clinic.
NCT03938688 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 325 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
primary outcome of interest is recurrence measured one year postoperatively as per standard of care at the 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), either during a physical or a virtual clinic visit and/or using the telephone. The VHRI is a validated patient reported outcomes tool, a three-question survey that can be administered directly to patients without
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 |
What the finished NCT03938688 record still lists
NCT03938688 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Mesh placement with Transfascial Sutures is the first listed.
NCT03938688 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03938688's enrollment target sits among peer trials
325 311th of 2000 higher than 1,689 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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