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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00908193
First received: May 22, 2009
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • quality of life (questionary SF-36) [ Time Frame: 1 month, 6 month and 12 month of surgery ] [ Designated as safety issue: No ]
  • length of stay in hospital, percentage return home to 24 hours of surgery [ Time Frame: to 24 hours of surgery ] [ Designated as safety issue: No ]
  • morbidity [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • resumption of work [ Time Frame: after surgery ] [ Designated as safety issue: No ]

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
Other Name: 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908193

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

No publications provided

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Treatment of abdominal ruptured
Digestive system disease
Coelioscopy
Assistance robotics
Medical device
DA VINCI Robot
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
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014