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

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.

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.