A Phase 4 interventional study of Laparoscopic DA VINCI Robot Assisted coelioscopy and conventional coelioscopy in Abdominal Wall Hernia, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment
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.
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).
90 studies on the registry are indexed under Hernia, Abdominal; 18 are open to participants now.
This study's enrollment of 70 is below the median of 96 across 57 interventional studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,578 studies on the registry; 1,030 are open to participants now.
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Exclusion Criteria:
robot-assisted coelioscopy
Device: Laparoscopic DA VINCI Robot Assisted coelioscopy
conventional coelioscopy
Procedure: conventional coelioscopy
Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate
Also known as: Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy
Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate
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
The record gives a start of Jul 2007, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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