Robotic Versus Laparoscopic Ventral Hernia Repair

May 23, 2022 updated by: Shinil Shah, The University of Texas Health Science Center, Houston

Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial

Ventral hernias are a common disease and one half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with significant morbidity, including surgical site infection, hernia recurrence and reoperation. Minimally invasive ventral hernia repair decreases rates of surgical site infection and hospital length of stay, without affecting recurrence, however the laparoscopic approach to ventral hernia repair accounts for only about 1/3 of all total hernia repairs performed in the US. Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.

Study Overview

Status

Completed

Conditions

Detailed Description

Ventral hernias are a common disease and one-half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias are associated with substantial morbidity including surgical site infection, hernia recurrence, and reoperation. Randomized controlled trials and nationwide databases have shown that minimally invasive ventral hernia repair (i.e. laparoscopic ventral hernia repair) as opposed to open ventral hernia repair is associated with decreased rates of surgical site infection and hospital length of stay with no impact on long-term outcomes of hernia recurrence.

Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.

The growth of the robotic platform in surgery is growing exponentially. Despite this, the evidence supporting robotics remains limited. Studies demonstrating benefit such as improved outcomes or decreased hospital length of stay, are largely cohort studies subject to substantial bias. Among randomized controlled trials, none have demonstrated benefit with robotic surgery.

Recently, the America's Hernia Society (AHS) has endorsed robotic ventral hernia surgery. A series of studies published under the AHS Quality Collaborative (AHSQC) database have demonstrated improved outcomes with robotic ventral hernia repair when compared to open and laparoscopic surgery. However, the results of these studies remain hypothesis generating and randomized controlled trials are needed.

This study would represent among the first randomized controlled trials assessing the effect of robotic versus laparoscopic ventral hernia repair.

Study Type

Interventional

Enrollment (Actual)

150

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

    • Texas
      • Houston, Texas, United States, 77024
        • UT Health-Memorial Hermann
      • Houston, Texas, United States, 77026
        • UTHealth-Lyndon B. Johnson (LBJ) Hospital

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:

-All patients undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair.

Exclusion Criteria:

  • Patients unlikely to survive beyond 2 years based upon surgeon judgment (e.g. advanced cirrhosis or metastatic cancer)
  • Patients unlikely to follow-up (e.g. lives out of state or no phone)
  • Advanced COPD or CHF
  • History of open abdomen or extensive lysis of adhesions for bowel obstruction
  • Ascites due to cirrhosis or malignancy
  • Active infection such as infected mesh
  • Ventral hernia size greater than 12 cm

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Laparoscopic Repair
The abdomen will be entered and insufflated utilizing a 5 mm optical port. Only 5 mm ports will be utilized laterally to take down all anterior abdominal wall adhesions. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through a 11 or 12 mm port placed through the defect. Excision of hernia sac and preperitoneal fat and defect closure will be performed per current practice. The mesh will be secured in four points with 0-PDS sutures and/or tacked with a double crown of tacks per our current practice.
The surgeon will be repairing the hernia laparoscopically.
EXPERIMENTAL: Robotic Repair
Three lateral ports will be placed including a 12 port for the camera. Adhesions will be taken down from the anterior abdominal wall. Hernia sac and preperitoneal fat will be excised per current practice and defect will be closed using a running locking barbed suture. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through the 12 mm port. The mesh will be secured circumferentially with a running barbed suture.
The surgeon will be utilizing a robotic system to repair the hernia.
Other Names:
  • da Vinci Si Surgical System
  • Endoscopic Instrument Control System, Model IS3000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of days in the hospital
Time Frame: 90 days post-operative
Total number of days spent in the hospital. This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery.
90 days post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection (SSI)
Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
CDC definition
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Surgical Site Occurrence (SSO)
Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam.
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Hernia Reoccurence
Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
A hernia that was repaired in the past but has returned
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Patient centered outcomes
Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Collected using HerQLes
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Patient centered outcomes
Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Collected using EQ5D
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Cost from a healthcare perspective
Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Looking at differences in what is spent for robotic repair and laparoscopic repair of ventral hernias
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Shinil Shah, DO, UTHealth-Memorial Hermann
  • Principal Investigator: Mike K Liang, MD, UTHealth-Lyndon B. Johnson (LBJ) Hospital

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

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)

April 3, 2018

Primary Completion (ACTUAL)

April 9, 2020

Study Completion (ACTUAL)

May 12, 2022

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (ACTUAL)

April 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HSC-MS-18-0137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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