Laparoscopic DA VINCI Robot Assisted Abdominal Wall Hernia Repair

Study Overview
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Brief Summary
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The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias . In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.

Detailed Description
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Laparoscopic Robot Assisted abdominal wall hernia repair : a prospective randomized trial: The main judgement criterion is post operative pain reflected by morphine consumption during the first 48 hours. Secondary criteria are morbidity, quality of life, duration of surgery, conversion rate, complications, the the length of stay and hospital costs. In this single centre study, inclusion criteria are age above 18, no previous repair of the hernia with a mesh and a diameter of the parietal defect of less than 10 cm. Contraindications are chronic use of pain drugs of level II or above and renal insufficiency (clearance <30ml/min). The robotic repair was described in a previous paper of our group and will be compared to our classical laparoscopic repair technique, and in both cases with the use of the same prosthetic mesh. A total of 70 patients to be included in an 18 months period was calculated to prove a 40% reduction in morphine consumption during the postoperative 48h (α=5% and β=10%). The total duration of the study is 30 months (12 months of follow-up for each patient).

Official Title
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Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia

Conditions
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Abdominal Wall Hernia

Intervention / Treatment
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* Device: Laparoscopic DA VINCI Robot Assisted coelioscopy
* Procedure: conventional coelioscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years with indication of hernia repair a collar with a diameter of less than 10cm no antecedent of hernia treatment with poses plate agreeing coelioscopy agreeing to participate the clinical study, having sign an informed consent agreeing a regular monitor Exclusion Criteria: taking analgesic tier 2 or 3 against indication to anesthetics or coelioscopy creatinine clearance less than 30 ml/min pregnant woman and protected persons no affiliation to social security unable to understand the information form

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>robot-assisted coelioscopy | Device: Laparoscopic DA VINCI Robot Assisted coelioscopy<br>* Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate<br>* Other names: Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy;|
| Active Comparator: 2<br>conventional coelioscopy | Procedure: conventional coelioscopy<br>* Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the reduction in morphine consumption |  | during the postoperative 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain patient (ENS, total consumption of morphine) |  | during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery | 
| quality of life (questionary SF-36) |  | 1 month, 6 month and 12 month of surgery | 
| length of stay in hospital, percentage return home to 24 hours of surgery |  | to 24 hours of surgery | 
| morbidity |  | during the study | 
| resumption of work |  | after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of abdominal ruptured, Digestive system disease, Coelioscopy, Assistance robotics, Medical device, DA VINCI Robot, Pain patient, Morphine consumption, Comparative Randomized study, patient over 18 years, with ruptured abdominal, with an indication of treatment of ruptured