Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM

July 18, 2022 updated by: Ajita Prabhu, MD, The Cleveland Clinic

Registry-Based, Prospective, Single-Blind, Randomized Controlled Trial: Robotic vs. Laparoscopic Ventral Hernia Repair With Intraperitoneal Onlay Mesh (IPOM)

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Comprehensive Hernia Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
Other Names:
  • da Vinci® Surgical System robotic platform
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.
Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores
Time Frame: Pain scores will be assessed on postoperative day 1, day 7 and day 30
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
Pain scores will be assessed on postoperative day 1, day 7 and day 30
Postoperative Pain Scores
Time Frame: 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
30 days(+-15days) postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Central 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
12 months +- 3 months
Cost of Robotic IPOM Versus Laparoscopic IPOM
Time Frame: Start of procedure to end of procedure which is an average of 2 hours
Start of procedure to end of procedure which is an average of 2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal Wall Specific Quality of Life
Time Frame: 30-days(+-15days) postoperatively
Abdominal Wall Specific Quality of Life will be assessed using the validated HerQLes (Hernia Related Quality of Life) survey. Scores will be reported as mean and standard deviations as appropriate on a scale from 0-100 with the larger numbers representing higher quality of life.
30-days(+-15days) postoperatively
Number of Participants With Surgical Site Infection
Time Frame: 30 days +- 15 days
Surgical site infection rates will be assessed and reported as percent
30 days +- 15 days
Number of Participants With 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
30 days +- 15 days
Number of Participants With 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
30-days +- 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2017

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 17-1053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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