Laparoscopic Versus Robot-assisted Ventral Hernia Repair: a Single Institution Randomized Controlled Trial

Study Overview
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Brief Summary
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Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.

Detailed Description
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Ventral hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.

Official Title
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Laparoscopic Versus Robot-assisted Ventral Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial

Conditions
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Ventral Hernia

Intervention / Treatment
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* Procedure: laparoscopic repair
* Procedure: robot-assisted repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: surgeon determined need for ventral hernia repair Exclusion Criteria: <18 & >99 years of age Pregnant Medical indication for open repair

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to receive either laparoscopic or robot-assisted repair of ventral hernia.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic ventral hernia<br>laparoscopic ventral hernia repair | Procedure: laparoscopic repair<br>* surgical repair of ventral hernia using laparoscopic repair<br>|
| Active Comparator: robot-assisted ventral hernia<br>robot-assisted ventral hernia repair | Procedure: robot-assisted repair<br>* surgical repair of ventral hernia using robot-assisted repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | time from start to finish of procedure, procedure start and stop times as recorded by anesthesia | perioperative time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain score | Abdominal pain at rest and on moving (recumbent to the upright position), will be assessed using 0-10 Numeric Pain Rating Scale preoperatively (baseline), and at 24 hours, 30 days, and one year postoperatively | until year five post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot-assisted