- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283982
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
Status
Completed
Conditions
Intervention / Treatment
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
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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:
|
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.
Sponsor
Collaborators
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.
General Publications
- 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, 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.
- 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.
- 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.
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
Keywords
Additional Relevant MeSH Terms
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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