Back to resultsClinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Gastric bypass
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Gastric bypass, Robot-assisted surgery, Conventional laparoscopy, Pain assessment, Health economics outcomes
Eligibility 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
Sites / Locations
- Service de Chirurgie Digestive et Endocrinienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot-assisted surgery
Conventional laparoscopy
Arm Description
Robot-assisted (da Vinci surgical system) gastric bypass
Laparoscopic gastric bypass
Outcomes
Primary Outcome Measures
24h postoperative pain
Pain assessment 24h post surgery (visual analog scale)
Secondary Outcome Measures
Evaluation of post-operative pain
Evaluation of post-operative pain (beyond 24h post-operative) using VAS
Evaluation of quality of life (BAROS and GIQLI)
Evaluation of quality of life using BAROS and GIQLI questionaires
Evaluation of appetite level
Evaluation of appetite level using VAS
Percentage of excess weight loss
Measure of excess weight loss - % from baseline
Conversion rate to conventional laparoscopy
Conversion rate to conventional laparoscopy (only applicable to robot-assisted surgery arm)
Nature of per-operative complications
Nature of per-operative complications
Nature of post-operative complications
Nature of post-operative complications
Evaluation of operative times
Evaluation of key steps of gastric bypass surgery, OR occupation time
Evaluation of direct costs
Direct costs include material used, OR occupation time, length of stay, return to normal activity
Evaluation of indirect costs
Combination of number of patients having surgery, perception of robot-assisted surgery by both personnel and patients, publications, and communications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01760512
Brief Title
Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IHU Strasbourg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Gastric bypass, Robot-assisted surgery, Conventional laparoscopy, Pain assessment, Health economics outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot-assisted surgery
Arm Type
Experimental
Arm Description
Robot-assisted (da Vinci surgical system) gastric bypass
Arm Title
Conventional laparoscopy
Arm Type
Active Comparator
Arm Description
Laparoscopic gastric bypass
Intervention Type
Procedure
Intervention Name(s)
Gastric bypass
Intervention Description
Gastric bypass
Primary Outcome Measure Information:
Title
24h postoperative pain
Description
Pain assessment 24h post surgery (visual analog scale)
Time Frame
24h
Secondary Outcome Measure Information:
Title
Evaluation of post-operative pain
Description
Evaluation of post-operative pain (beyond 24h post-operative) using VAS
Time Frame
24h, 8 days, 1, 3, 6 and 12 months
Title
Evaluation of quality of life (BAROS and GIQLI)
Description
Evaluation of quality of life using BAROS and GIQLI questionaires
Time Frame
At 1, 3, 6 and 12 months
Title
Evaluation of appetite level
Description
Evaluation of appetite level using VAS
Time Frame
At 8 days, 1, 3, 6 and 12 months
Title
Percentage of excess weight loss
Description
Measure of excess weight loss - % from baseline
Time Frame
At 8 days, 1, 3, 6 and 12 months
Title
Conversion rate to conventional laparoscopy
Description
Conversion rate to conventional laparoscopy (only applicable to robot-assisted surgery arm)
Time Frame
During the procedure (Day 0)
Title
Nature of per-operative complications
Description
Nature of per-operative complications
Time Frame
During the procedure (Day 0)
Title
Nature of post-operative complications
Description
Nature of post-operative complications
Time Frame
Following the procedure (Day 0) up to 12 months
Title
Evaluation of operative times
Description
Evaluation of key steps of gastric bypass surgery, OR occupation time
Time Frame
During the procedure (Day 0)
Title
Evaluation of direct costs
Description
Direct costs include material used, OR occupation time, length of stay, return to normal activity
Time Frame
During the procedure (day 0) and up to 12 months
Title
Evaluation of indirect costs
Description
Combination of number of patients having surgery, perception of robot-assisted surgery by both personnel and patients, publications, and communications
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Vix
Organizational Affiliation
Service de Chirurgie Générale et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Digestive et Endocrinienne
City
Strasbourg
ZIP/Postal Code
67 000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass
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