NCT03490266

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

March 21, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

April 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2020

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

March 21, 2018

Last Update Submit

May 23, 2022

Conditions

Hernia, Ventral

Keywords

Ventral HerniaHernia Repair

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days post-operative

Secondary Outcomes (6)

  • Surgical Site Infection (SSI)

    post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

  • Surgical Site Occurrence (SSO)

    post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

  • Hernia Reoccurence

    post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

  • Patient centered outcomes

    post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

  • Patient centered outcomes

    post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years

  • +1 more secondary outcomes

Study Arms (2)

Laparoscopic Repair

ACTIVE COMPARATOR

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

Robotic Repair

EXPERIMENTAL

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

Interventions

Robotic RepairPROCEDURE

The surgeon will be utilizing a robotic system to repair the hernia.

Also known as: da Vinci Si Surgical System, Endoscopic Instrument Control System, Model IS3000
Robotic Repair
Laparoscopic RepairPROCEDURE

The surgeon will be repairing the hernia laparoscopically.

Laparoscopic Repair

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UT Health-Memorial Hermann

Houston, Texas, 77024, United States

Location

UTHealth-Lyndon B. Johnson (LBJ) Hospital

Houston, Texas, 77026, United States

Location

Related Publications (15)

  • 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.

    PMID: 28828517BACKGROUND

  • 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.

    PMID: 28009730BACKGROUND

  • 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.

    PMID: 26206646BACKGROUND

  • 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.

    PMID: 28557648BACKGROUND

  • 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.

    PMID: 27569431BACKGROUND

  • 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.

    PMID: 28350568BACKGROUND

  • 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

  • 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.

    PMID: 28984644BACKGROUND

  • 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.

    PMID: 29243456BACKGROUND

  • 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.

    PMID: 28895658BACKGROUND

  • 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.

    PMID: 29017732BACKGROUND

  • 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.

    PMID: 19495920BACKGROUND

  • Dhanani NH, Lyons NB, Olavarria OA, Bernardi K, Holihan JL, Shah SK, Wilson TD, Loor MM, Kao LS, Liang MK. Robotic Versus Laparoscopic Ventral Hernia Repair: Two-Year Results From a Prospective, Multicenter, Blinded Randomized Clinical Trial. Ann Surg. 2023 Aug 1;278(2):161-165. doi: 10.1097/SLA.0000000000005903. Epub 2023 May 19.

    PMID: 37203558DERIVED

  • 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.

    PMID: 33630447DERIVED

  • 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.

    PMID: 32665218DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Shinil Shah, DO

    UTHealth-Memorial Hermann

    PRINCIPAL INVESTIGATOR

  • Mike K Liang, MD

    UTHealth-Lyndon B. Johnson (LBJ) Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2018

First Posted

April 6, 2018

Study Start

April 3, 2018

Primary Completion

April 9, 2020

Study Completion

May 12, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)