Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation
Completed · Not applicable
Conditions studied: Ventral Hernia, Incisional Hernia
In brief
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
Key facts
- Study ID
- NCT03938688
- Run by
- The Cleveland Clinic
- People needed
- 325
- Starts
- 2019-10-21
- Expected to finish
- 2022-12-18
- Last updated by the study team
- 2023-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Undergoing elective open ventral hernia repair, where the midline fascia can be approximated and mesh will be placed in the retromuscular position
- A midline approach to hernia repair
- Hernia widths equal to or less than 20cm measured intraoperatively
You may not qualify if…
- Patients unable to give consent and vulnerable populations.
- Parastomal hernias
- Hernia width measuring more than 20cm intraoperatively
- Patients planned for minimally invasive approaches or open repairs with mesh placed in a position other than retromuscular, or those who were not able to undergo successful retromuscular mesh placement.
- Open repairs performed through a different incision than the standard midline approach
- Inability to close the midline fascia.
Where it is running
- Cleveland Clinic Center for Abdominal Core Health — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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