Groupe Hospitalier Chenevier-Mondor
Créteil, 94000, France
NCT Number: NCT00908193
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Créteil, 94000, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate
Other names: Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy
Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate
Time frame: during the postoperative 48h
Time frame: during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery
Time frame: 1 month, 6 month and 12 month of surgery
Time frame: to 24 hours of surgery
Time frame: during the study
Time frame: after surgery
Assistance Publique - Hôpitaux de Paris
Other
Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia
Acronym: ARTE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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