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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00908193
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):
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.

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).

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Study Type : Interventional  (Clinical Trial)
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 : July 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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 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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00908193

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Groupe Hospitalier Chenevier-Mondor
Créteil, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Claude Tayar Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00908193    
Other Study ID Numbers: P051080
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 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:
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Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical