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.