Robotic Versus Laparoscopic Ventral Hernia Repair

Hernia, Ventral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490266
• Other study ID #: HSC-MS-18-0137
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: May 12, 2022

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 12, 2022
• Est. primary completion date: April 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Intervention

Procedure:
• Robotic Repair
The surgeon will be utilizing a robotic system to repair the hernia.
• Laparoscopic Repair
The surgeon will be repairing the hernia laparoscopically.

Locations

Country	Name	City	State
United States	UT Health-Memorial Hermann	Houston	Texas
United States	UTHealth-Lyndon B. Johnson (LBJ) Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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:CD009625. doi: 10.1002/14651858.CD009625.pub2. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical Site Infection (SSI)	CDC definition	post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Secondary	Surgical Site Occurrence (SSO)	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
Secondary	Hernia Reoccurence	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
Secondary	Patient centered outcomes	Collected using HerQLes	post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Secondary	Patient centered outcomes	Collected using EQ5D	post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Secondary	Cost from a healthcare perspective	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