Clinical trial NCT03283982: Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM
Official title: Registry-Based, Prospective, Single-Blind, Randomized Controlled Trial: Robotic vs. Laparoscopic Ventral Hernia Repair With Intraperitoneal Onlay Mesh (IPOM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Keywords: Ventral Hernia
Robotic
Laparoscopic
Pain scores
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2017-09-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain Scores
timeFrame: Pain scores will be assessed on postoperative day 1, day 7 and day 30
measure: Postoperative Pain Scores
timeFrame: 30 days(+-15days) postoperatively
Secondary outcomes:
measure: Number of Participants With Central Hernia Recurrence
timeFrame: 12 months +- 3 months
measure: Cost of Robotic IPOM Versus Laparoscopic IPOM
timeFrame: Start of procedure to end of procedure which is an average of 2 hours
Other outcomes:
measure: Abdominal Wall Specific Quality of Life
timeFrame: 30-days(+-15days) postoperatively
measure: Number of Participants With Surgical Site Infection
timeFrame: 30 days +- 15 days
measure: Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention
timeFrame: 30 days +- 15 days
measure: Number of Participants With Surgical Site Occurrences
timeFrame: 30-days +- 15 days
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Comprehensive Hernia Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ajita Prabhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Asencio F, Aguilo J, Peiro S, Carbo 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.
citation: Petro CC, Thomas JD, Tu C, Krpata DM, Beffa LR, Rosen MJ, Prabhu AS. Robotic vs Laparoscopic Ventral Hernia Repair with Intraperitoneal Mesh: 1-Year Exploratory Outcomes of the PROVE-IT Randomized Clinical Trial. J Am Coll Surg. 2022 Jun 1;234(6):1160-1165. doi: 10.1097/XCS.0000000000000171. Epub 2022 Mar 14.
citation: Petro CC, Zolin S, Krpata D, Alkhatib H, Tu C, Rosen MJ, Prabhu AS. Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh: The PROVE-IT Randomized Clinical Trial. JAMA Surg. 2021 Jan 1;156(1):22-29. doi: 10.1001/jamasurg.2020.4569.