Robotic Versus Open Primary Ventral Hernia Repair

Ventral Hernia Clinical Trial

— Robovent  

Official title:

Robotic Versus Open Primary Ventral Hernia Repair: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04171921
• Other study ID #: 2019-00113
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2023
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Umbilical and epigastric hernia repair, whether considering primary or incisional hernias, are associated with a high risk of local complications, with global rate of surgical complications at one month up to 25%. To date three techniques are used. Open ventral hernia repair (OVHR) is associated with a high risk of surgical site infection, wound dehiscence, and hematoma, but is the main technique due to advantages such as cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic hernia repair (LHR) reduces these complications but implies to place a mesh in intra-peritoneal position which is known to lead to adhesions, requires advanced laparoscopic skills, does not allow the closure of the defect due to limited range of motion, and can lead to excessive pain and pain-killers consumption due to the use of "tackers" to hold the mesh in place. Robotic ventral hernia repair (RVHR) uses the same laparoscopic access as LHR but thanks to the extended range of motion given by the robotic system allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills. LHR is of very low adoption in Geneva University Hospital for the aforementioned inconvenient. Moreover, the final result of the procedure is not the same than with OVHR or RVHR, since the defect is not primarily closed and the mesh is in intra-peritoneal position. OVHR and RVHR , however, lead to the same final result and only defer by the access type (direct vs. laparoscopic). RVHR is gaining rapid popularity and adoption in the United States but remains a costly solution. It is unclear whether the supposed benefits for the patients of RVHR overwhelm the extra costs and time, especially by reducing the complication rate and consecutive in-hospital and out-hospital costs. Moreover, increasing experience of the robotic system in Geneva University Hospital has led to a significant costs and time reduction in other robotic procedures and could eventually make RVHR cost effective if its clinical benefits were to be proven. This study aims at demonstrating that robotic trans-abdominal pre-peritoneal (rTAPP) primary ventral hernia repair leads to lower surgical site complication rate than the same procedure performed through standard open approach (OVHR), while being an acceptable solution from an economic, operative time and functional standpoint.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 162
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Informed Consent as documented by signature
• Aged 18 years or older
• Undergoing primary umbilical or epigastric hernia repair of size between 1cm and 5cm +/-5mm, with mesh reinforcement, in the Visceral Surgery Department of the University Geneva Hospital

Exclusion Criteria:

• Patients under corticosteroids or other immunosuppressive treatment
• Pregnancy or breastfeeding
• Intention to become pregnant during the course of the study
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential
• Incisional hernia and/or substantial history of intra-abdominal surgery
• Upon anesthesiologist evaluation, clinically significant concomitant disease states which require to shorten operative time at maximum
• Upon anesthesiologist evaluation, clinically significant concomitant disease states being a contra-indication to laparoscopic approach and/or general anesthesia
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the participant
• Previous enrolment into the current study
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Procedure:
• Robotic ventral hernia repair
Laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement
• Open ventral hernia repair
Standard open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement

Locations

Country	Name	City	State
Switzerland	Visceral surgery department - Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

Bisgaard T, Kehlet H, Bay-Nielsen M, Iversen MG, Rosenberg J, Jorgensen LN. A nationwide study on readmission, morbidity, and mortality after umbilical and epigastric hernia repair. Hernia. 2011 Oct;15(5):541-6. doi: 10.1007/s10029-011-0823-z. Epub 2011 May 3. — View Citation

Colavita PD, Tsirline VB, Belyansky I, Walters AL, Lincourt AE, Sing RF, Heniford BT. Prospective, long-term comparison of quality of life in laparoscopic versus open ventral hernia repair. Ann Surg. 2012 Nov;256(5):714-22; discussion 722-3. doi: 10.1097/ — View Citation

Froylich D, Segal M, Weinstein A, Hatib K, Shiloni E, Hazzan D. Laparoscopic versus open ventral hernia repair in obese patients: a long-term follow-up. Surg Endosc. 2016 Feb;30(2):670-675. doi: 10.1007/s00464-015-4258-y. Epub 2015 Jun 20. — View Citation

Hajibandeh S, Hajibandeh S, Sreh A, Khan A, Subar D, Jones L. Laparoscopic versus open umbilical or paraumbilical hernia repair: a systematic review and meta-analysis. Hernia. 2017 Dec;21(6):905-916. doi: 10.1007/s10029-017-1683-y. Epub 2017 Oct 14. — View Citation

Helgstrand F. National results after ventral hernia repair. Dan Med J. 2016 Jul;63(7):B5258. — View Citation

Hilling DE, Koppert LB, Keijzer R, Stassen LP, Oei IH. Laparoscopic correction of umbilical hernias using a transabdominal preperitoneal approach: results of a pilot study. Surg Endosc. 2009 Aug;23(8):1740-4. doi: 10.1007/s00464-008-0177-5. Epub 2008 Nov 18. — 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

Liang MK, Berger RL, Li LT, Davila JA, Hicks SC, Kao LS. Outcomes of laparoscopic vs open repair of primary ventral hernias. JAMA Surg. 2013 Nov;148(11):1043-8. doi: 10.1001/jamasurg.2013.3587. — View Citation

Muysoms FE, Bontinck J, Pletinckx P. Complications of mesh devices for intraperitoneal umbilical hernia repair: a word of caution. Hernia. 2011 Aug;15(4):463-8. doi: 10.1007/s10029-010-0692-x. Epub 2010 Jun 17. — View Citation

Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9. — View Citation

Reynolds D, Davenport DL, Korosec RL, Roth JS. Financial implications of ventral hernia repair: a hospital cost analysis. J Gastrointest Surg. 2013 Jan;17(1):159-66; discussion p.166-7. doi: 10.1007/s11605-012-1999-y. Epub 2012 Sep 11. — View Citation

Tandon A, Pathak S, Lyons NJ, Nunes QM, Daniels IR, Smart NJ. Meta-analysis of closure of the fascial defect during laparoscopic incisional and ventral hernia repair. Br J Surg. 2016 Nov;103(12):1598-1607. doi: 10.1002/bjs.10268. Epub 2016 Aug 22. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site complication	Yes or no	At 31 days after surgery
Secondary	Detailed surgical site complications	Classified according to aforementioned Clavien-Dindo's scoring system (scale from 1 to 5, higher score mean a worse outcome)	At 31 days after surgery
Secondary	General complications, not directly related to surgical site	Classified according to aforementioned Clavien-Dindo's scoring system (scale from 1 to 5, higher score mean a worse outcome)	At 31 days after surgery
Secondary	General pain: Visual Analogue Scale	Evaluated using Visual Analogue Scale (VAS, scale from 0 to 10, higher score mean a worse outcome))	At 31 days after surgery
Secondary	Painkillers consumption	Recorded from patient's medical record for in-hospital stay for out-hospital period will be evaluated with consumption recall at each visit	At 31 days after surgery
Secondary	Esthetic satisfaction: European Hernia Society Quality of Life (EuraHS-QoL)	Using European Hernia Society Quality of Life (EuraHS-QoL) ( scale from 0-90, with the lower scores being the most favorable outcome)	At 31 days after surgery
Secondary	Quality of life score	Using European Hernia Society Quality of Life (EuraHS-QoL) form (scale from 0-90, with the lower scores being the most favorable outcome)	At 31 days after surgery
Secondary	In-hospital costs	Hospitalization costs including medications, care and labs, cost of the procedure, diagnosis related group class, total amount billed to the insurance.; Derived using REKOLE® method.	At day 31 after surgery
Secondary	Out-hospital costs	Consults and drugs Estimated based on hospital's billing data.	At day 31 after surgery
Secondary	Early recurrence at 1 month	Evaluated by physical evaluation	At day 31 after surgery
Secondary	Defect size	Measured with ruler	During surgery
Secondary	Number of device related adverse events by the operating surgeon	Surgical complications which are identified by the operating surgeon as directly related to malfunction of the robotic system	During surgery