Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM

Not Applicable

Completed

Conditions: Ventral Hernia

Interventions: Device: Robotic Ventral Hernia Repair with IPOM
Device: Laparoscopic Ventral Hernia Repair with IPOM

Registration Number: NCT03283982

Lead Sponsor: The Cleveland Clinic

Brief Summary: The investigators aim to conduct a registry-based, randomized controlled trial to investigate if the robotic platform for minimally invasive ventral hernia repair with intraperitoneal onlay mesh (IPOM), when compared to the laparoscopic platform, will influence on early postoperative pain scores, wound morbidity (surgical site infections, surgical site occurrences and surgical site occurrences requiring procedural intervention), ventral hernia recurrence rate and abdominal wall-specific quality of life.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic IPOM	Robotic Ventral Hernia Repair with IPOM	Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic IPOM	Laparoscopic Ventral Hernia Repair with IPOM	Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Scores	30 days(+-15days) postoperatively	Pain scores will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) 3a Pain Intensity Survey. Measured on a scale of 30.7- 71.8 with the higher numbers indicating higher pain

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Central Hernia Recurrence	12 months +- 3 months	Ventral Hernia recurrence will be assessed at 1 year postoperatively, either by physical examination, imaging studies or using the validated Ventral Hernia Recurrence Inventory Survey. Rates of ventral hernia recurrence will be reported as percent
Cost of Robotic IPOM Versus Laparoscopic IPOM	Start of procedure to end of procedure which is an average of 2 hours