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

Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Wall Hernia
• Intervention / Treatment: Device: Laparoscopic DA VINCI Robot Assisted coelioscopy; Procedure: conventional coelioscopy

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Groupe Hospitalier Chenevier-Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the reduction in morphine consumption	during the postoperative 48h

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Claude Tayar, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 22, 2009
• First Submitted That Met QC Criteria: May 22, 2009
• First Posted (Estimate): May 25, 2009

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Medical device; Coelioscopy; Morphine consumption; Treatment of abdominal ruptured; Digestive system disease; Assistance robotics; DA VINCI Robot; Pain patient; Comparative Randomized study; patient over 18 years; with ruptured abdominal; with an indication of treatment of ruptured
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: P051080