Robotic Versus Open Primary Ventral Hernia Repair

Not Applicable

Active, not recruiting

• Conditions: Ventral Hernia
• Interventions: Procedure: Robotic ventral hernia repair; Procedure: Open ventral hernia repair

• Registration Number: NCT04171921
• Lead Sponsor: University of Geneva, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic ventral hernia repair	Robotic ventral hernia repair	-
Open ventral hernia repair	Open ventral hernia repair	-

Primary Outcome Measures

Name	Time	Method
Surgical site complication	At 31 days after surgery	Yes or no

Secondary Outcome Measures

Name	Time	Method
Defect size	During surgery	Measured with ruler
Detailed surgical site complications	At 31 days after surgery	Classified according to aforementioned Clavien-Dindo's scoring system (scale from 1 to 5, higher score mean a worse outcome)
General complications, not directly related to surgical site	At 31 days after surgery	Classified according to aforementioned Clavien-Dindo's scoring system (scale from 1 to 5, higher score mean a worse outcome)
Esthetic satisfaction: European Hernia Society Quality of Life (EuraHS-QoL)	At 31 days after surgery	Using European Hernia Society Quality of Life (EuraHS-QoL) ( scale from 0-90, with the lower scores being the most favorable outcome)
In-hospital costs	At day 31 after surgery	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.
Out-hospital costs	At day 31 after surgery	Consults and drugs Estimated based on hospital's billing data.
Early recurrence at 1 month	At day 31 after surgery	Evaluated by physical evaluation
General pain: Visual Analogue Scale	At 31 days after surgery	Evaluated using Visual Analogue Scale (VAS, scale from 0 to 10, higher score mean a worse outcome))
Painkillers consumption	At 31 days after surgery	Recorded from patient's medical record for in-hospital stay for out-hospital period will be evaluated with consumption recall at each visit
Quality of life score	At 31 days after surgery	Using European Hernia Society Quality of Life (EuraHS-QoL) form (scale from 0-90, with the lower scores being the most favorable outcome)
Number of device related adverse events by the operating surgeon	During surgery	Surgical complications which are identified by the operating surgeon as directly related to malfunction of the robotic system

Trial Locations

Locations (1)

Visceral surgery department - Geneva University Hospital; 🇨🇭 Geneva, Switzerland