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Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03283982
Recruitment Status : Completed
First Posted : September 15, 2017
Results First Posted : July 19, 2022
Last Update Posted : July 25, 2022
Sponsor:
Collaborator:
Intuitive Surgical
Information provided by (Responsible Party):
Ajita Prabhu, MD, 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.

Condition or disease Intervention/treatment Phase
Ventral Hernia Device: Robotic Ventral Hernia Repair with IPOM Device: Laparoscopic Ventral Hernia Repair with IPOM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Registry-Based, Prospective, Single-Blind, Randomized Controlled Trial: Robotic vs. Laparoscopic Ventral Hernia Repair With Intraperitoneal Onlay Mesh (IPOM)
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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.
Device: Robotic Ventral Hernia Repair with IPOM
Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
Other Name: 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.
Device: Laparoscopic Ventral Hernia Repair with IPOM
Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Cost of Robotic IPOM Versus Laparoscopic IPOM [ Time Frame: Start of procedure to end of procedure which is an average of 2 hours ]

Other Outcome Measures:
  1. 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.

  2. Number of Participants With Surgical Site Infection [ Time Frame: 30 days +- 15 days ]
    Surgical site infection rates will be assessed and reported as percent

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283982


Locations
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United States, Ohio
Cleveland Clinic Comprehensive Hernia Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Intuitive Surgical
Investigators
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Principal Investigator: Ajita Prabhu, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Ajita Prabhu, MD, The Cleveland Clinic:
Informed Consent Form  [PDF] August 18, 2018

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ajita Prabhu, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03283982    
Other Study ID Numbers: 17-1053
First Posted: September 15, 2017    Key Record Dates
Results First Posted: July 19, 2022
Last Update Posted: July 25, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared.

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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
Keywords provided by Ajita Prabhu, MD, The Cleveland Clinic:
Ventral Hernia
Robotic
Laparoscopic
Pain scores
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal