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Robotic Versus Laparoscopic Ventral Hernia Repair

Primary Purpose

Hernia, Ventral

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic Repair
Laparoscopic Repair
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Ventral focused on measuring Ventral Hernia, Hernia Repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Health-Memorial Hermann
  • UTHealth-Lyndon B. Johnson (LBJ) Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Laparoscopic Repair

Robotic Repair

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total number of days in the hospital
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

Surgical Site Infection (SSI)
CDC definition
Surgical Site Occurrence (SSO)
Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam.
Hernia Reoccurence
A hernia that was repaired in the past but has returned
Patient centered outcomes
Collected using HerQLes
Patient centered outcomes
Collected using EQ5D
Cost from a healthcare perspective
Looking at differences in what is spent for robotic repair and laparoscopic repair of ventral hernias

Full Information

First Posted
March 21, 2018
Last Updated
May 23, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03490266
Brief Title
Robotic Versus Laparoscopic Ventral Hernia Repair
Official Title
Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
April 9, 2020 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral
Keywords
Ventral Hernia, Hernia Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Repair
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Robotic Repair
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Robotic Repair
Other Intervention Name(s)
da Vinci Si Surgical System, Endoscopic Instrument Control System, Model IS3000
Intervention Description
The surgeon will be utilizing a robotic system to repair the hernia.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Repair
Intervention Description
The surgeon will be repairing the hernia laparoscopically.
Primary Outcome Measure Information:
Title
Total number of days in the hospital
Description
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.
Time Frame
90 days post-operative
Secondary Outcome Measure Information:
Title
Surgical Site Infection (SSI)
Description
CDC definition
Time Frame
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Title
Surgical Site Occurrence (SSO)
Description
Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam.
Time Frame
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Title
Hernia Reoccurence
Description
A hernia that was repaired in the past but has returned
Time Frame
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Title
Patient centered outcomes
Description
Collected using HerQLes
Time Frame
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Title
Patient centered outcomes
Description
Collected using EQ5D
Time Frame
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Title
Cost from a healthcare perspective
Description
Looking at differences in what is spent for robotic repair and laparoscopic repair of ventral hernias
Time Frame
post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinil Shah, DO
Organizational Affiliation
UTHealth-Memorial Hermann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mike K Liang, MD
Organizational Affiliation
UTHealth-Lyndon B. Johnson (LBJ) Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health-Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
UTHealth-Lyndon B. Johnson (LBJ) Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28828517
Citation
Cherla DV, Moses ML, Viso CP, Holihan JL, Flores-Gonzalez JR, Kao LS, Ko TC, Liang MK. Impact of Abdominal Wall Hernias and Repair on Patient Quality of Life. World J Surg. 2018 Jan;42(1):19-25. doi: 10.1007/s00268-017-4173-6.
Results Reference
background
PubMed Identifier
28009730
Citation
Liang MK, Holihan JL, Itani K, Alawadi ZM, Gonzalez JR, Askenasy EP, Ballecer C, Chong HS, Goldblatt MI, Greenberg JA, Harvin JA, Keith JN, Martindale RG, Orenstein S, Richmond B, Roth JS, Szotek P, Towfigh S, Tsuda S, Vaziri K, Berger DH. Ventral Hernia Management: Expert Consensus Guided by Systematic Review. Ann Surg. 2017 Jan;265(1):80-89. doi: 10.1097/SLA.0000000000001701.
Results Reference
background
PubMed Identifier
26206646
Citation
Holihan JL, Alawadi Z, Martindale RG, Roth JS, Wray CJ, Ko TC, Kao LS, Liang MK. Adverse Events after Ventral Hernia Repair: The Vicious Cycle of Complications. J Am Coll Surg. 2015 Aug;221(2):478-85. doi: 10.1016/j.jamcollsurg.2015.04.026. Epub 2015 May 9.
Results Reference
background
PubMed Identifier
28557648
Citation
Holihan JL, Hannon C, Goodenough C, Flores-Gonzalez JR, Itani KM, Olavarria O, Mo J, Ko TC, Kao LS, Liang MK. Ventral Hernia Repair: A Meta-Analysis of Randomized Controlled Trials. Surg Infect (Larchmt). 2017 Aug/Sep;18(6):647-658. doi: 10.1089/sur.2017.029. Epub 2017 May 30.
Results Reference
background
PubMed Identifier
27569431
Citation
Holihan JL, Alawadi ZM, Harris JW, Harvin J, Shah SK, Goodenough CJ, Kao LS, Liang MK, Roth JS, Walker PA, Ko TC. Ventral hernia: Patient selection, treatment, and management. Curr Probl Surg. 2016 Jul;53(7):307-54. doi: 10.1067/j.cpsurg.2016.06.003. Epub 2016 Jun 18. No abstract available.
Results Reference
background
PubMed Identifier
28350568
Citation
Carbonell AM, Warren JA, Prabhu AS, Ballecer CD, Janczyk RJ, Herrera J, Huang LC, Phillips S, Rosen MJ, Poulose BK. Reducing Length of Stay Using a Robotic-assisted Approach for Retromuscular Ventral Hernia Repair: A Comparative Analysis From the Americas Hernia Society Quality Collaborative. Ann Surg. 2018 Feb;267(2):210-217. doi: 10.1097/SLA.0000000000002244.
Results Reference
background
PubMed Identifier
28450062
Citation
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.
Results Reference
background
PubMed Identifier
28984644
Citation
Prete FP, Pezzolla A, Prete F, Testini M, Marzaioli R, Patriti A, Jimenez-Rodriguez RM, Gurrado A, Strippoli GFM. Robotic Versus Laparoscopic Minimally Invasive Surgery for Rectal Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg. 2018 Jun;267(6):1034-1046. doi: 10.1097/SLA.0000000000002523.
Results Reference
background
PubMed Identifier
29243456
Citation
Tasiopoulou VS, Svokos AA, Svokos KA, Zacharoulis D, Magouliotis DE. Robotic versus laparoscopic sleeve gastrectomy: a review of the current evidence. Minerva Chir. 2018 Feb;73(1):55-63. doi: 10.23736/S0026-4733.17.07583-6. Epub 2017 Dec 14.
Results Reference
background
PubMed Identifier
28895658
Citation
Ilic D, Evans SM, Allan CA, Jung JH, Murphy D, Frydenberg M. Laparoscopic and robotic-assisted versus open radical prostatectomy for the treatment of localised prostate cancer. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD009625. doi: 10.1002/14651858.CD009625.pub2.
Results Reference
background
PubMed Identifier
29017732
Citation
Coakley KM, Sims SM, Prasad T, Lincourt AE, Augenstein VA, Sing RF, Heniford BT, Colavita PD. A nationwide evaluation of robotic ventral hernia surgery. Am J Surg. 2017 Dec;214(6):1158-1163. doi: 10.1016/j.amjsurg.2017.08.022. Epub 2017 Sep 20.
Results Reference
background
PubMed Identifier
19495920
Citation
Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3.
Results Reference
background
PubMed Identifier
33630447
Citation
Dhanani NH, Olavarria OA, Holihan JL, Shah SK, Wilson TD, Loor MM, Ko TC, Kao LS, Liang MK. Robotic Versus Laparoscopic Ventral Hernia Repair: One-year Results From a Prospective, Multicenter, Blinded Randomized Controlled Trial. Ann Surg. 2021 Jun 1;273(6):1076-1080. doi: 10.1097/SLA.0000000000004795.
Results Reference
derived
PubMed Identifier
32665218
Citation
Olavarria OA, Bernardi K, Shah SK, Wilson TD, Wei S, Pedroza C, Avritscher EB, Loor MM, Ko TC, Kao LS, Liang MK. Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial. BMJ. 2020 Jul 14;370:m2457. doi: 10.1136/bmj.m2457.
Results Reference
derived

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Robotic Versus Laparoscopic Ventral Hernia Repair

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