Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair

Abdominal Wall Hernia Clinical Trial

— ARTE  

Official title:

Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908193
• Other study ID #: P051080
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2009
• Last updated: August 1, 2013
• Start date: July 2007
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Wall Hernia
• Hernia
• Hernia, Ventral

Intervention

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

Procedure:
• conventional coelioscopy
Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate

Locations

Country	Name	City	State
France	Groupe Hospitalier Chenevier-Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the reduction in morphine consumption		during the postoperative 48h	No
Secondary	Pain patient (ENS, total consumption of morphine)		during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery	No
Secondary	quality of life (questionary SF-36)		1 month, 6 month and 12 month of surgery	No
Secondary	length of stay in hospital, percentage return home to 24 hours of surgery		to 24 hours of surgery	No
Secondary	morbidity		during the study	No
Secondary	resumption of work		after surgery	No