Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair (ARTE)
Primary Purpose
Abdominal Wall Hernia
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Laparoscopic DA VINCI Robot Assisted coelioscopy
conventional coelioscopy
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Wall Hernia focused on measuring 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
Eligibility 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
Sites / Locations
- Groupe Hospitalier Chenevier-Mondor
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
robot-assisted coelioscopy
conventional coelioscopy
Outcomes
Primary Outcome Measures
Evaluate the reduction in morphine consumption
Secondary Outcome Measures
Pain patient (ENS, total consumption of morphine)
quality of life (questionary SF-36)
length of stay in hospital, percentage return home to 24 hours of surgery
morbidity
resumption of work
Full Information
NCT ID
NCT00908193
First Posted
May 22, 2009
Last Updated
August 1, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00908193
Brief Title
Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair
Acronym
ARTE
Official Title
Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Wall Hernia
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
robot-assisted coelioscopy
Arm Title
2
Arm Type
Active Comparator
Arm Description
conventional coelioscopy
Intervention Type
Device
Intervention Name(s)
Laparoscopic DA VINCI Robot Assisted coelioscopy
Other Intervention Name(s)
Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy
Intervention Description
Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate
Intervention Type
Procedure
Intervention Name(s)
conventional coelioscopy
Intervention Description
Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate
Primary Outcome Measure Information:
Title
Evaluate the reduction in morphine consumption
Time Frame
during the postoperative 48h
Secondary Outcome Measure Information:
Title
Pain patient (ENS, total consumption of morphine)
Time Frame
during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery
Title
quality of life (questionary SF-36)
Time Frame
1 month, 6 month and 12 month of surgery
Title
length of stay in hospital, percentage return home to 24 hours of surgery
Time Frame
to 24 hours of surgery
Title
morbidity
Time Frame
during the study
Title
resumption of work
Time Frame
after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Tayar
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Chenevier-Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
12. IPD Sharing Statement
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Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair
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