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

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: May 22, 2009
Last updated: August 1, 2013
Last verified: July 2013

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 Intervention Phase
Abdominal Wall Hernia
Device: Laparoscopic DA VINCI Robot Assisted coelioscopy
Procedure: conventional coelioscopy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Evaluate the reduction in morphine consumption [ Time Frame: during the postoperative 48h ]

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

Enrollment: 70
Study Start Date: July 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00908193

Groupe Hospitalier Chenevier-Mondor
Créteil, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Claude Tayar Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00908193     History of Changes
Other Study ID Numbers: P051080
Study First Received: May 22, 2009
Last Updated: August 1, 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Treatment of abdominal ruptured
Digestive system disease
Assistance robotics
Medical device
Pain patient
Morphine consumption
Comparative Randomized study
patient over 18 years
with ruptured abdominal
with an indication of treatment of ruptured

Additional relevant MeSH terms:
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal processed this record on May 25, 2017