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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic ventral hernia repair | Active Comparator |
| |
| Open ventral hernia repair | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic ventral hernia repair | Procedure | Laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site complication | Yes or no | At 31 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| General complications, not directly related to surgical site |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Douissard, MD | University of Geneva, Geneva University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visceral surgery department - Geneva University Hospital | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21904861 | Background | 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. | |
| 26206646 | Background | 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. |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D010146 | Pain |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Open ventral hernia repair | Procedure | Standard open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 REKOLEĀ® method. | At day 31 after surgery |
| Out-hospital costs | Consults and drugs Estimated based on hospital's billing data. | At day 31 after surgery |
| Early recurrence at 1 month | Evaluated by physical evaluation | At day 31 after surgery |
| Defect size | Measured with ruler | During surgery |
| 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 |
| 21538150 | Background | 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. |
| 27399983 | Background | Helgstrand F. National results after ventral hernia repair. Dan Med J. 2016 Jul;63(7):B5258. |
| 22965649 | Background | 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. |
| 29032495 | Background | 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. |
| 26091995 | Background | 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. |
| 20556448 | Background | 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. |
| 24005537 | Background | 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. |
| 27546188 | Background | 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. |
| 19015918 | Background | 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. |
| 23095614 | Result | 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/SLA.0b013e3182734130. |
| 32368702 | Derived | Douissard J, Meyer J, Dupuis A, Peloso A, Mareschal J, Toso C, Hagen M. Robotic versus open primary ventral hernia repair: A randomized controlled trial (Robovent Trial). Int J Surg Protoc. 2020 Apr 4;21:27-31. doi: 10.1016/j.isjp.2020.03.004. eCollection 2020. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |