Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair (ARTE)
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.
|Abdominal Wall Hernia||Device: Laparoscopic DA VINCI Robot Assisted coelioscopy Procedure: conventional coelioscopy||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia|
- Evaluate the reduction in morphine consumption [ Time Frame: during the postoperative 48h ]
- Pain patient (ENS, total consumption of morphine) [ Time Frame: during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery ]
- quality of life (questionary SF-36) [ Time Frame: 1 month, 6 month and 12 month of surgery ]
- length of stay in hospital, percentage return home to 24 hours of surgery [ Time Frame: to 24 hours of surgery ]
- morbidity [ Time Frame: during the study ]
- resumption of work [ Time Frame: after surgery ]
|Study Start Date:||July 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Device: Laparoscopic DA VINCI Robot Assisted coelioscopy
Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate
Other Name: Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy
Active Comparator: 2
Procedure: conventional coelioscopy
Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908193
|Groupe Hospitalier Chenevier-Mondor|
|Créteil, France, 94000|
|Principal Investigator:||Claude Tayar||Assistance Publique - Hôpitaux de Paris|