ARTE: Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00908193

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Wall Hernia	Device: Laparoscopic DA VINCI Robot Assisted coelioscopy Procedure: conventional coelioscopy	Phase 4

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 robot-assisted coelioscopy	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 Names: Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy
Active Comparator: 2 conventional coelioscopy	Procedure: conventional coelioscopy Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate

Arm

Intervention/Treatment

Experimental: 1

robot-assisted coelioscopy

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 Names:

Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy

Active Comparator: 2

conventional coelioscopy

Procedure: conventional coelioscopy

Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate

Outcome Measures

Primary Outcome Measures

Evaluate the reduction in morphine consumption [during the postoperative 48h]

Secondary Outcome Measures

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]