Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair (ARTE)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Abdominal Wall Hernia

Treatments: Device: Laparoscopic DA VINCI Robot Assisted coelioscopy; Procedure: conventional coelioscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00908193

P051080

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

1

Experimental group

Description:

robot-assisted coelioscopy

Treatment:

Device: Laparoscopic DA VINCI Robot Assisted coelioscopy

2

Active Comparator group

Description:

conventional coelioscopy

Treatment:

Procedure: conventional coelioscopy