Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial
1 other identifier
interventional
189
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 16, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJuly 20, 2018
July 1, 2018
4.2 years
February 2, 2015
July 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Satisfaction and function
Change in patient satisfaction and function evaluated through the modified Activities Assessment Scale, a validated, hernia-specific score that can be compared pre- and post-operative
12 months
Secondary Outcomes (3)
Surgical site infection
30 days after surgery
Hernia recurrence and clinical bulging/eventration
2 years after surgery
Clinical bulging/eventration
2 years after surgery
Study Arms (2)
Bridging LVHR
OTHERLaparoscopic ventral hernia repair without closure of central defect (bridging repair) Upon completion of the lysis of adhesions, the margins of the hernia defect will be measured and marked. The hernia defect size will be measured with the abdomen completely desufflated and insufflated at 15 mm Hg externally (on the skin). A coated mesh with at least four cm of overlap on all sides will be placed. Mesh will be secured with at least four but no more than eight trans-fascial sutures. Titanium tacks will be placed in a double crown technique where tacks are placed every 1 cm on the periphery and every 3 cm along the fascial edge (bridged or closed).
LVHR PFC
OTHERVentral hernia repairs in the primary fascial group will be performed similarly except prior to placement of the mesh, the defect will be closed. After the defect size is measured, the mesh will be chosen based upon the unclosed defect size and size will not be adjusted. The hernia defect will be closed as described previously 9,10 with 0-prolene transfascial sutures placed every 1-2 cm. The two caudal-most and cranial-most sutures will be placed. The abdomen will be desufflated and these sutures will be secured. The abdomen will be reinsufflated to 15 mm Hg and the defect progressively closed. Upon completion of fascial closure, the mesh will be placed in the standard fashion as describe above. The lateral overlap will be increased due to the fascial closure.
Interventions
Information included in arm description
Information included in arm description
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
George Washington University
Washington D.C., District of Columbia, 20037, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
University of Nevada at Las Vegas
Las Vegas, Nevada, 89102, United States
Lyndon B. Johnson General Hospital
Houston, Texas, 77026, United States
Related Publications (1)
Bernardi K, Olavarria OA, Holihan JL, Kao LS, Ko TC, Roth JS, Tsuda S, Vaziri K, Liang MK. Primary Fascial Closure During Laparoscopic Ventral Hernia Repair Improves Patient Quality of Life: A Multicenter, Blinded Randomized Controlled Trial. Ann Surg. 2020 Mar;271(3):434-439. doi: 10.1097/SLA.0000000000003505.
PMID: 31365365DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mike K Liang, MD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 16, 2015
Study Start
March 1, 2015
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
July 20, 2018
Record last verified: 2018-07