Clinical trial NCT00908193: Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair
Official title: Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-05-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Evaluate the reduction in morphine consumption
timeFrame: during the postoperative 48h
Secondary outcomes:
measure: Pain patient (ENS, total consumption of morphine)
timeFrame: during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery
measure: quality of life (questionary SF-36)
timeFrame: 1 month, 6 month and 12 month of surgery
measure: length of stay in hospital, percentage return home to 24 hours of surgery
timeFrame: to 24 hours of surgery
measure: morbidity
timeFrame: during the study
measure: resumption of work
timeFrame: after surgery
Other outcomes:
Locations:
city: Créteil
country: France
facility: Groupe Hospitalier Chenevier-Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claude Tayar
role: PRINCIPAL_INVESTIGATOR
References: