Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair

NCT00908193 | Completed Phase 4 DMC

• 1 other identifier: P051080
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the reduction in morphine consumption

  during the postoperative 48h

Secondary Outcomes (5)

• Pain patient (ENS, total consumption of morphine)

  during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery

• quality of life (questionary SF-36)

  1 month, 6 month and 12 month of surgery

• length of stay in hospital, percentage return home to 24 hours of surgery

  to 24 hours of surgery

• morbidity

  during the study

• resumption of work

  after surgery

Study Arms (2)

1

EXPERIMENTAL

robot-assisted coelioscopy

Device: Laparoscopic DA VINCI Robot Assisted coelioscopy

2

ACTIVE COMPARATOR

conventional coelioscopy

Procedure: conventional coelioscopy

Interventions

Laparoscopic DA VINCI Robot Assisted coelioscopy DEVICE

Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate

Also known as: Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy

1

conventional coelioscopy PROCEDURE

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Chenevier-Mondor

Créteil, 94000, France

Location

MeSH Terms

Conditions

Hernia, Abdominal; Digestive System Diseases

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Claude Tayar

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 25, 2009
• Study Start: July 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 2, 2013

Record last verified: 2013-07

Locations

FR (1)