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

NCT ID: NCT02363790

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-05-31

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.

Detailed Description

Introduction: While randomized controlled trials have demonstrated that laparoscopic ventral hernia repair (LVHR) as compared to open repair is associated with decreased rates of surgical site infection (SSI) and shorter lengths of hospital stay, the adoption of LVHR has been limited. Less than one-fourth of ventral hernias are repaired with a laparoscopic approach in the United States. One of the main reasons cited for the lack of widespread adoption of LVHR is failure to improve patient symptoms. Following LVHR, up to 70% of patients continue to complain of an abdominal bulge and one-third of patients complain of poor function. The investigators have previously reported that primary fascial closure (PFC) with LVHR is feasible and when compared to case-matched controls, PFC improved outcomes of recurrence, bulging, and patient function.

Hypotheses: Primary Hypothesis: In patients undergoing LVHR, PFC as opposed to a bridged repair will improve patient reported satisfaction and function at 1 year of follow-up. Secondary Hypotheses: (1) PFC is safe and feasible to perform by general surgeons facile at LVHR. Compared to bridged LVHR, (2) PFC will decrease recurrence rates and (3) PFC will decrease the rate of clinician-diagnosed eventration following LVHR.

Methods: A randomized controlled trial to compare the outcomes of two methods of LVHR: bridged repair with mesh or PFC with mesh will be performed. PFC is estimated to improve patient satisfaction and patient function from composite scores on the validated and hernia-specific Modified Activities Assessment Scale (best score of 100). We expect the change in score (1 year mAAS score minus baseline scores) of the two groups to be 40 and 26 with a standard deviation of 25. Assuming a two-sided alpha of 0.05 and beta of 0.20, and 20% dropout rate, 120 patients will need to be randomized (n=60/group). The investigators' healthcare system performed 300 LVHRs last year. The investigators anticipate being able to accrue the sample size in 12 months.

Randomization and Allocation: In the operating room, prior to mesh placement, the patient will be randomized using a computer-generated sequence in variable permuted blocks. Allocation will be through a phone call to the study office. We chose to stratify the patient by hernia defect size instead of stratifying by baseline PCO.

Data Collection and Outcomes: A surgeon blinded to the treatment allocation will perform post-operative assessment at 14 days, 30 days, and 1 year post-operative. The primary outcome of change in patient-reported satisfaction and function will be assessed through the validated, hernia-specific survey, modified Activities Assessment Scale. Secondary outcomes will include all intra-operative complications related to PFC, hernia recurrence, clinician-assessed eventration, and any Dindo-Clavien 2-5 complication. Other patient reported outcomes assessed include likelihood to undergo the surgery again, likelihood to recommend surgery to their family or friends, and levels of pain.

Analysis: The primary outcome will be compared using Wilcoxon Rank Sum test. A Bayesian analysis will be performed to determine the posterior point estimates, credible intervals, and probability to decrease hernia recurrence with PFC will be calculated. In order to refine the study, when half of the expected patients (88) completed 1 year follow up we performed a blinded interim power analysis. We compared the change in PCO between the two groups and refined the sample size. Based upon these findings, the sample size was decreased from 176 to 120 patients.

Anticipated Results: This study will provide patients and providers with high-quality information on the risks and benefits of PFC versus bridging repair in LVHR. If efficacious, a multi-center effectiveness trial to assess long-term outcomes such as hernia recurrence can be performed.

Conditions

Hernia, Ventral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bridging LVHR

Laparoscopic 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).

Group Type: OTHER

Bridging LVHR

Intervention Type: PROCEDURE

Information included in arm description

LVHR PFC

Ventral 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.

Group Type: OTHER

LVHR PFC

Intervention Type: PROCEDURE

Information included in arm description

Interventions

LVHR PFC

Information included in arm description

Intervention Type: PROCEDURE

Bridging LVHR

Information included in arm description

Intervention Type: PROCEDURE

Other Intervention Names

Trancutaneous closure of the central defect; standard LVHR

Eligibility Criteria

Inclusion Criteria

1. Patient desires an elective surgical repair,

2. patient is able to give informed consent,

3. diagnosis of a midline ventral hernia with a fascial defect width on clinical examination or CT scan of 3-10 cm in size,

4. body mass index <40kg/m2,

5. candidate for LVHR based upon surgeon assessment.

Exclusion Criteria

1. acute or urgent presentation,

2. multiple defects defined as defects from two separate incisions,

3. patient has loss of domain assessed,

4. patient has a severe co-morbid condition likely to limit survival to <2 years,

5. contamination noted pre-operative or intra-operative,

6. patient is pregnant or intends to become pregnant during the study period.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Mike K Liang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mike K Liang, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31365365 (View on PubMed)

Other Identifiers

HSC-MS-14-0170

Identifier Type: -

Identifier Source: org_study_id