Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass

This study is currently recruiting participants.
Verified September 2013 by IHU Strasbourg
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg
ClinicalTrials.gov Identifier:
NCT01760512
First received: December 10, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass).

This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative complication incidence. It will also provide information on direct and indirect costs of surgery.


Condition Intervention
Morbid Obesity
Procedure: Gastric bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective, Single-blind, Randomized, Non-inferiority, and Controlled Study of Clinical and Health Economic Impact of Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery: the Case of Gastric Bypass

Resource links provided by NLM:


Further study details as provided by IHU Strasbourg:

Primary Outcome Measures:
  • 24h postoperative pain [ Time Frame: 24h ] [ Designated as safety issue: No ]
    Pain assessment 24h post surgery (visual analog scale)


Secondary Outcome Measures:
  • Evaluation of post-operative pain [ Time Frame: 24h, 8 days, 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Evaluation of post-operative pain (beyond 24h post-operative) using VAS

  • Evaluation of quality of life (BAROS and GIQLI) [ Time Frame: At 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Evaluation of quality of life using BAROS and GIQLI questionaires

  • Evaluation of appetite level [ Time Frame: At 8 days, 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Evaluation of appetite level using VAS

  • Percentage of excess weight loss [ Time Frame: At 8 days, 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Measure of excess weight loss - % from baseline

  • Conversion rate to conventional laparoscopy [ Time Frame: During the procedure (Day 0) ] [ Designated as safety issue: No ]
    Conversion rate to conventional laparoscopy (only applicable to robot-assisted surgery arm)

  • Nature of per-operative complications [ Time Frame: During the procedure (Day 0) ] [ Designated as safety issue: Yes ]
    Nature of per-operative complications

  • Nature of post-operative complications [ Time Frame: Following the procedure (Day 0) up to 12 months ] [ Designated as safety issue: Yes ]
    Nature of post-operative complications

  • Evaluation of operative times [ Time Frame: During the procedure (Day 0) ] [ Designated as safety issue: No ]
    Evaluation of key steps of gastric bypass surgery, OR occupation time

  • Evaluation of direct costs [ Time Frame: During the procedure (day 0) and up to 12 months ] [ Designated as safety issue: No ]
    Direct costs include material used, OR occupation time, length of stay, return to normal activity

  • Evaluation of indirect costs [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Combination of number of patients having surgery, perception of robot-assisted surgery by both personnel and patients, publications, and communications


Estimated Enrollment: 118
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robot-assisted surgery
Robot-assisted (da Vinci surgical system) gastric bypass
Procedure: Gastric bypass
Gastric bypass
Active Comparator: Conventional laparoscopy
Laparoscopic gastric bypass
Procedure: Gastric bypass
Gastric bypass

Detailed Description:

Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery (Gastric Bypass): a prospective, single-blind, randomized, non-inferiority, and controlled study The main evaluation criterion is 24h post-operative pain assessed using visual analog scale (VAS). Secondary criteria included for clinical assessment: post 24h pain, excess weight loss, quality of life, appetite, complications, conversion rate; and for health-economics assessment : duration of surgical steps, length of stay, return to normal activity and their conversion to cost, consumables, estimation of indirect costs and benefits (e.g., robotics perception, publication).

In this study, main inclusion criteria include major obesity (IMC ≥ 35) with co-morbidities or morbid obesity (IMC ≥ 40), scheduled gastric bypass surgery Main contraindications are previous bariatric surgery and previous major abdominal surgeries To test robotic-assisted surgery non-inferiority on VAS pain score 24h post-surgery, a total of 128 patients (64 per arm) is to be included (alpha 2,5%; power 90%; drop-out rate: 5%).

The study will include 12 months of follow-up post-surgery for each patient. The total study duration is 2 years and 3 months.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient presenting with major obesity (BMI ≥ 35) with co-morbidities or morbid obesity (BMI ≥ 40)according to French HAS (Haute Autorité de Santé) and CNAMTS (Caisse nationale de l'assurance maladie des travailleurs salariés)criteria for whom gastric bypass is scheduled
  • Male or female between 18 and 65 years old
  • Patient registered with the French Social Security
  • Patient having provided a written informed consent prior to enrolment
  • Patient accepting to attend follow-up visits as required by study protocol

Exclusion Criteria:

  • Patient with a BMI ≥ 60
  • Patient with a contraindication for laparoscopic gastric bypass with or without robotic assistance
  • Patient having had prior bariatric surgery
  • Patient having had prior major abdominal surgery
  • Patient in exclusion period of another clinical study
  • Patient pregnant or breastfeeding
  • Patient without sufficient knowledge of french language or unable to receive or understand study related information and answer to questionnaires
  • Patient with no or limited legal capacity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760512

Contacts
Contact: Michel Vix, MD +33 3 69 55 05 49 michel.vix@chru-strasbourg.fr

Locations
France
Service de Chirurgie Digestive et Endocrinienne Recruiting
Strasbourg, France, 67 000
Principal Investigator: Michel Vix, MD         
Sponsors and Collaborators
IHU Strasbourg
Investigators
Principal Investigator: Michel Vix Service de Chirurgie Générale et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
  More Information

No publications provided

Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT01760512     History of Changes
Other Study ID Numbers: 12-002
Study First Received: December 10, 2012
Last Updated: September 12, 2013
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by IHU Strasbourg:
Gastric bypass
Robot-assisted surgery
Conventional laparoscopy
Pain assessment
Health economics outcomes

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014