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.
Full Title of Study: “Registry-Based, Prospective, Single-Blind, Randomized Controlled Trial: Robotic vs. Laparoscopic Ventral Hernia Repair With Intraperitoneal Onlay Mesh (IPOM)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: January 31, 2021
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.
- Device: Robotic Ventral Hernia Repair with IPOM
- Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
- Device: Laparoscopic Ventral Hernia Repair with IPOM
- Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
Arms, Groups and Cohorts
- Active Comparator: Robotic 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.
- Active Comparator: Laparoscopic 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.
Clinical Trial Outcome Measures
- Postoperative Pain Scores
- Time Frame: Pain scores will be assessed on baseline, on postoperative days 1,7 and 30 and 365.
- Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from ‘0’ representing one pain extreme (e.g. “no pain”) to ’10’ representing the other pain extreme (e.g. “pain as bad as you can imagine” or “worst pain imaginable”); This will be reported using median and interquartile ranges
- Surgical Site Infection
- Time Frame: 30 days +- 15 days
- Surgical site infection rates will be assessed and reported as percent
- Surgical Site Occurrences
- Time Frame: 30-days +- 15 days
- Surgical site occurrences ( defined as wound cellulitis, non-healing wound, fascial disruption, skin or soft tissue ischemia or necrosis, wound drainage, stitch abscess, seroma, hematoma, exposed, contaminated or infected mesh and enterocutaneous fistula) will be assessed and reported as percent
- Surgical Site Occurrences requiring Procedural Intervention
- Time Frame: 30 days +- 15 days
- Surgical Site Occurrences requiring Procedural Intervention will be assessed and reported as percent
- Ventral Hernia Recurrence
- Time Frame: 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
- Abdominal Wall Specific Quality of Life
- Time Frame: Baseline, 30-days(+-15days) and 12 months (+- 3 months) postoperatively
- Abdominal Wall Specific Quality of Life will be assessed using the validated HerQLes survey, and will be assessed at baseline, 30-days and 1-year postoperatively. Scores will be reported as mean and standard deviations as appropriate.
- Postoperative pain scores
- Time Frame: Baseline, 30 days(+-15days) and 12 months (+- 3 months) postoperatively
- Pain scores will be assessed using the PROMIS 3a Pain Intensity Survey (Patient-Reported Outcomes Measurement Information System);
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- The Cleveland Clinic
- Intuitive Surgical
- Provider of Information About this Clinical Study
- Principal Investigator: Ajita Prabhu, MD, Principal Investigator – The Cleveland Clinic
- Overall Official(s)
- Ajita Prabhu, MD, Principal Investigator, The Cleveland Clinic
Prabhu AS, Dickens EO, Copper CM, Mann JW, Yunis JP, Phillips S, Huang LC, Poulose BK, Rosen MJ. Laparoscopic vs Robotic Intraperitoneal Mesh Repair for Incisional Hernia: An Americas Hernia Society Quality Collaborative Analysis. J Am Coll Surg. 2017 Aug;225(2):285-293. doi: 10.1016/j.jamcollsurg.2017.04.011. Epub 2017 Apr 24.
Asencio F, Aguiló J, Peiró S, Carbó J, Ferri R, Caro F, Ahmad M. Open randomized clinical trial of laparoscopic versus open incisional hernia repair. Surg Endosc. 2009 Jul;23(7):1441-8. doi: 10.1007/s00464-008-0230-4. Epub 2008 Dec 31.
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