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

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ClinicalTrials.gov Identifier: NCT01760512
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg

Tracking Information
First Submitted Date  ICMJE December 10, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE November 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
24h postoperative pain [ Time Frame: 24h ]
Pain assessment 24h post surgery (visual analog scale)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2013)
  • Evaluation of post-operative pain [ Time Frame: 24h, 8 days, 1, 3, 6 and 12 months ]
    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 ]
    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 ]
    Evaluation of appetite level using VAS
  • Percentage of excess weight loss [ Time Frame: At 8 days, 1, 3, 6 and 12 months ]
    Measure of excess weight loss - % from baseline
  • Conversion rate to conventional laparoscopy [ Time Frame: During the procedure (Day 0) ]
    Conversion rate to conventional laparoscopy (only applicable to robot-assisted surgery arm)
  • Nature of per-operative complications [ Time Frame: During the procedure (Day 0) ]
    Nature of per-operative complications
  • Nature of post-operative complications [ Time Frame: Following the procedure (Day 0) up to 12 months ]
    Nature of post-operative complications
  • Evaluation of operative times [ Time Frame: During the procedure (Day 0) ]
    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 ]
    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 ]
    Combination of number of patients having surgery, perception of robot-assisted surgery by both personnel and patients, publications, and communications
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • Evaluation of post-operative pain [ Time Frame: 24h, 8 days, 1, 3, 6 and 12 months ]
    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 ]
    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 ]
    Evaluation of appetite level using VAS
  • Percentage of excess weight loss [ Time Frame: At 8 days, 1, 3, 6 and 12 months ]
    Measure of excess weight loss - % from baseline
  • Conversion rate to conventional laparoscopy [ Time Frame: During surgery ]
    Conversion rate to conventional laparoscopy (only applicable to robot-asssited surgery arm)
  • Nature of per-operative complications [ Time Frame: During surgery ]
    Nature of per-operative complications
  • Nature of post-operative complications [ Time Frame: Following surgery up to 12 months ]
    Nature of post-operative complications
  • Evaluation of operative times [ Time Frame: During surgery ]
    Evaluation of key steps of gastric bypass surgery, OR occupation time
  • Evaluation of direct costs [ Time Frame: During surgery and up to 12 months ]
    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 ]
    Combination of number of patients having surgery, perception of robot-assisted surgery by both personnel and patients, publications, and communications
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass
Official Title  ICMJE 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
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE Procedure: Gastric bypass
Gastric bypass
Study Arms  ICMJE
  • Experimental: Robot-assisted surgery
    Robot-assisted (da Vinci surgical system) gastric bypass
    Intervention: Procedure: Gastric bypass
  • Active Comparator: Conventional laparoscopy
    Laparoscopic gastric bypass
    Intervention: Procedure: Gastric bypass
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 2, 2013)
118
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760512
Other Study ID Numbers  ICMJE 12-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IHU Strasbourg
Study Sponsor  ICMJE IHU Strasbourg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel Vix Service de Chirurgie Générale et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
PRS Account IHU Strasbourg
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP