Clinical trial NCT02363790: Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial
Official title: Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Ventral
Keywords: Ventral Hernia
Laparoscopic
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient Satisfaction and function
timeFrame: 12 months
Secondary outcomes:
measure: Surgical site infection
timeFrame: 30 days after surgery
measure: Hernia recurrence and clinical bulging/eventration
timeFrame: 2 years after surgery
measure: Clinical bulging/eventration
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Las Vegas
country: United States
facility: University of Nevada at Las Vegas
state: Nevada
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Mike K Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.