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Robotic Versus Laparoscopic Ventral Hernia Repair

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ClinicalTrials.gov Identifier: NCT03490266
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Shinil Shah, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hernia, Ventral Procedure: Robotic Repair Procedure: Laparoscopic Repair Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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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.
 Procedure: Laparoscopic Repair
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.
 Procedure: Robotic Repair
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Surgical Site Infection (SSI) [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    CDC definition

  2. 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.

  3. 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

  4. Patient centered outcomes [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    Collected using HerQLes

  5. Patient centered outcomes [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    Collected using EQ5D

  6. 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


Eligibility Criteria
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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:

-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
Contacts and Locations
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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): NCT03490266


Contacts
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Contact: Shinil Shah, DO 713-892-5500 Shinil.K.Shah@uth.tmc.edu
Contact: Angielyn Rivera 713-486-1350 Angielyn.R.Rivera@uth.tmc.edu

Locations
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United States, Texas
UT Health-Memorial Hermann Not yet recruiting
Houston, Texas, United States, 77024
Contact: Shinil Shah, DO    713-892-5500    Shinil.K.Shah@uth.tmc.edu   
Contact: Angielyn Rivera    713-486-1350    Angielyn.R.Rivera@uth.tmc.edu   
UTHealth-Lyndon B. Johnson (LBJ) Hospital Recruiting
Houston, Texas, United States, 77026
Contact: Mike K Liang, MD    713-566-5098    Mike.K.Liang@uth.tmc.edu   
Contact: Debbie F Lew, MPH, CCRC    713-566-5097    Debbie.F.Lew@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Shinil Shah, DO UTHealth-Memorial Hermann
Principal Investigator: Mike K Liang, MD UTHealth-Lyndon B. Johnson (LBJ) Hospital
More Information
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Publications:

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Responsible Party: Shinil Shah, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03490266     History of Changes
Other Study ID Numbers: HSC-MS-18-0137
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Shinil Shah, The University of Texas Health Science Center, Houston:
Ventral Hernia
Hernia Repair
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal