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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

Tracking Information
First Submitted Date  ICMJE March 21, 2018
First Posted Date  ICMJE April 6, 2018
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE April 3, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03490266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Surgical Site Infection (SSI) [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    CDC definition
  • 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.
  • 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
  • Patient centered outcomes [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    Collected using HerQLes
  • Patient centered outcomes [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    Collected using EQ5D
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Surgical Site Infection (SSI) [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    CDC definition
  • Surgical Site Occurrence (SSO) [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    SSI, hematoma, seroma, dehiscence, necrosis, non-healing wound
  • 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
  • Patient centered outcomes [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    Collected using HerQLes
  • Patient centered outcomes [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]
    Collected using EQ5D
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robotic Versus Laparoscopic Ventral Hernia Repair
Official Title  ICMJE Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hernia, Ventral
Intervention  ICMJE
  • 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
  • Procedure: Laparoscopic Repair
    The surgeon will be repairing the hernia laparoscopically.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Laparoscopic Repair
  • 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.
    Intervention: Procedure: Robotic Repair
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03490266
Other Study ID Numbers  ICMJE HSC-MS-18-0137
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shinil Shah, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shinil Shah, DO UTHealth-Memorial Hermann
Principal Investigator: Mike K Liang, MD UTHealth-Lyndon B. Johnson (LBJ) Hospital
PRS Account The University of Texas Health Science Center, Houston
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP