NCT03283982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 19, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

3.4 years

First QC Date

September 8, 2017

Results QC Date

May 11, 2022

Last Update Submit

July 18, 2022

Conditions

Ventral Hernia

Keywords

Ventral HerniaRoboticLaparoscopicPain scores

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain Scores

    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

    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 Outcomes (2)

  • Number of Participants With Central Hernia Recurrence

    12 months +- 3 months

  • Cost of Robotic IPOM Versus Laparoscopic IPOM

    Start of procedure to end of procedure which is an average of 2 hours

Other Outcomes (4)

  • Abdominal Wall Specific Quality of Life

    30-days(+-15days) postoperatively

  • Number of Participants With Surgical Site Infection

    30 days +- 15 days

  • Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention

    30 days +- 15 days

  • +1 more other outcomes

Study Arms (2)

Robotic IPOM

ACTIVE COMPARATOR

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

Laparoscopic IPOM

ACTIVE COMPARATOR

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

Interventions

Robotic Ventral Hernia Repair with IPOMDEVICE

Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform

Also known as: da Vinci® Surgical System robotic platform
Robotic IPOM
Laparoscopic Ventral Hernia Repair with IPOMDEVICE

Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform

Laparoscopic IPOM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Comprehensive Hernia Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (4)

  • 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.

    PMID: 28450062BACKGROUND

  • 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.

    PMID: 19116750BACKGROUND

  • 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.

    PMID: 35703814DERIVED

  • 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.

    PMID: 33084881DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Ajita Prabhu
Organization
Cleveland Clinic Foundation
prabhua@ccf.org
2164444790

Study Officials

  • Ajita Prabhu, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 15, 2017

Study Start

September 11, 2017

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

July 25, 2022

Results First Posted

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

No IPD will be shared.

Locations

US(1)