Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial

Status unconfirmed · Not applicable

Conditions studied: Hernia, Ventral

In brief

This study is comparing the outcomes patients undergoing LVHR, PFC as opposed to a bridged repair with assessment of patient reported satisfaction and function at 6 months of follow-up.

Key facts

Study ID

NCT02363790

Run by

The University of Texas Health Science Center, Houston

People needed

189

Starts

2015-03-01

Expected to finish

2019-05-01

Last updated by the study team

2018-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient desires an elective surgical repair,
• patient is able to give informed consent,
• diagnosis of a midline ventral hernia with a fascial defect width on clinical examination or CT scan of 3-10 cm in size,
• body mass index <40kg/m2,
• candidate for LVHR based upon surgeon assessment.

You may not qualify if…

• acute or urgent presentation,
• multiple defects defined as defects from two separate incisions,
• patient has loss of domain assessed,
• patient has a severe co-morbid condition likely to limit survival to <2 years,
• contamination noted pre-operative or intra-operative,
• patient is pregnant or intends to become pregnant during the study period.

Where it is running

• George Washington University — Washington D.C., District of Columbia, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Nevada at Las Vegas — Las Vegas, Nevada, United States
• Lyndon B. Johnson General Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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