Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair

Phase 4

Completed

• Conditions: Abdominal Wall Hernia
• Interventions: Device: Laparoscopic DA VINCI Robot Assisted coelioscopy; Procedure: conventional coelioscopy

• Registration Number: NCT00908193
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Laparoscopic DA VINCI Robot Assisted coelioscopy	robot-assisted coelioscopy
2	conventional coelioscopy	conventional coelioscopy

Primary Outcome Measures

Name	Time	Method
Evaluate the reduction in morphine consumption	during the postoperative 48h

Secondary Outcome Measures

Name	Time	Method
morbidity	during the study
Pain patient (ENS, total consumption of morphine)	during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery
length of stay in hospital, percentage return home to 24 hours of surgery	to 24 hours of surgery
resumption of work	after surgery
quality of life (questionary SF-36)	1 month, 6 month and 12 month of surgery

Trial Locations

Locations (1)

Groupe Hospitalier Chenevier-Mondor; 🇫🇷 Créteil, France