Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM

Despite the adoption of the robotic platform for ventral hernia repair, there is still a
paucity of literature to speak to the benefits of this approach. In a recently-published
propensity score analysis comparing laparoscopic and robotic ventral hernia repairs with
intraperitoneal onlay mesh (IPOM) , the authors showed a 1-day decrease in hospital length of
stay (LOS) with the robotic versus laparoscopic platform for laparoscopic ventral hernia
repair with IPOM. The reasons for this decrease in stay remain unknown. While multiple papers
have described postoperative pain scores following laparoscopic ventral hernia repair, scant
data exists evaluating postoperative pain following robotic ventral hernia repair. To help
determine if the robotic platform has an impact on postoperative pain, wound morbidity rates,
ventral hernia recurrence and quality of life, the investigators propose a registry-based,
randomized clinical trial (RCT) through the Americas Hernia Society Quality Collaborative
(AHSQC). The AHSQC is a multicenter, nationwide quality improvement effort with a mission to
improve value in hernia care. Data are collected prospectively in the routine care of hernia
patients for quality improvement purposes. The information collected in the AHSQC offers a
natural repository of information that can be used for research, in addition to its quality
improvement purpose. The investigators aim to conduct a prospective, registry-based,
single-blind, randomized controlled trial with a 1:1 allocation ratio. This will be a
single-institutional study performed at the Cleveland Clinic Foundation in Cleveland, Ohio
from 2017 to 2020. All enrollments and surgeries in this study will take place at the
Cleveland Clinic Comprehensive Hernia Center. The study will consist of 2 interventions:
laparoscopic IPOM or robotic IPOM. Participants will be randomized to laparoscopic ventral
hernia repair with IPOM or robotic ventral hernia repair with IPOM at the moment of
enrollment, during preoperative evaluation. Participants will be blinded to the intervention.
Both the laparoscopic and robotic platforms represent current standards of care for ventral
hernia repair, and both approaches are currently offered at Cleveland Clinic Comprehensive
Hernia Center. The sample size was determined by the primary outcome of interest, the change
in NRS-11 pain score at postoperative day 1. The investigators hypothesize that the robotic
approach will be associated with a 30% decrease in NRS-11 pain score at postoperative day 1.
The 30% reduction used for power calculations was determined from clinical judgment, as
little literature exists evaluating the minimal clinically important difference of the NRS-11
scale for ventral hernia repair. Mean NRS-11 pain score (4.76) and standard deviation (1.975)
with the laparoscopic approach (control group) was determined from previously published
manuscripts. Assuming an alpha of 0.05, a beta of 0.20, a total sample size of 62 patients
(31 per arm) was calculated. Considering and a 20% drop-out rate to occur in each arm,
approximately 74 patients (37 patients per arm) was defined as the sample size for this
study. Descriptive statistics, including means, standard deviations, and/or percentages, will
be calculated for demographic and baseline variables. Categorical variables will be reported
using proportions. Continuous variables will be reported using either means and standard
deviations for normally distributed data or median and interquartile range for non-parametric
data. Pain scores will be compared between intervention arms at each time point using either
a Student's t-test (normal distribution) or a Kruskal-Wallis test (nonparametric
distribution). Differences in PROMIS scores between baseline, 30 and 365 days, respectively,
will be assessed via Wilcoxon signed-rank test. Recurrence rates will be compared between
intervention arms via Pearson's chi-square. Abdominal wall-specific quality of life scores
will be compared between intervention arms via Kruskal-Wallis test. Wound events will be
compared between intervention arms via Pearson's chi-square.

Inclusion Criteria:

- Adult patients (>18 years old)

- Primary or Incisional Ventral Hernia

- Midline defect location

- H. Width equal or less than 7 centimeters

- Elective setting

- Able to give informed consent

- Able to tolerate general anesthesia

- Considered eligible for minimally invasive ventral hernia repair

- Willing to undergo mesh-based repair

- Fascial closure is presumed to be achieved

Exclusion Criteria:

- Younger than 18 years old

- Non-midline hernia defects

- H. Width > 7cm

- Emergent setting ( acute incarceration or strangulation)

- Unable to give informed consent

- Unable to tolerate general anesthesia

- Considered not eligible for minimally invasive ventral hernia repair

- Not willing to undergo mesh based repair

- Fascial closure not intended or presumed not to be achieved