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Completed

NCT Number: NCT00908193

Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Groupe Hospitalier Chenevier-Mondor

Créteil, 94000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy

conventional coelioscopy

Procedure

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

Primary outcomes

  1. Evaluate the reduction in morphine consumption

    Time frame: during the postoperative 48h

Secondary outcomes

  1. Pain patient (ENS, total consumption of morphine)

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

  2. quality of life (questionary SF-36)

    Time frame: 1 month, 6 month and 12 month of surgery

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

    Time frame: to 24 hours of surgery

  4. morbidity

    Time frame: during the study

  5. resumption of work

    Time frame: after surgery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia

Acronym: ARTE

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
May 25, 2009
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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