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

Morbid Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760512
• Other study ID #: 12-002
• Status: Completed
• Phase: N/A
• First received: December 10, 2012
• Last updated: December 9, 2015
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Gastric bypass
Gastric bypass

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24h postoperative pain	Pain assessment 24h post surgery (visual analog scale)	24h	No
Secondary	Evaluation of post-operative pain	Evaluation of post-operative pain (beyond 24h post-operative) using VAS	24h, 8 days, 1, 3, 6 and 12 months	No
Secondary	Evaluation of quality of life (BAROS and GIQLI)	Evaluation of quality of life using BAROS and GIQLI questionaires	At 1, 3, 6 and 12 months	No
Secondary	Evaluation of appetite level	Evaluation of appetite level using VAS	At 8 days, 1, 3, 6 and 12 months	No
Secondary	Percentage of excess weight loss	Measure of excess weight loss - % from baseline	At 8 days, 1, 3, 6 and 12 months	No
Secondary	Conversion rate to conventional laparoscopy	Conversion rate to conventional laparoscopy (only applicable to robot-assisted surgery arm)	During the procedure (Day 0)	No
Secondary	Nature of per-operative complications	Nature of per-operative complications	During the procedure (Day 0)	Yes
Secondary	Nature of post-operative complications	Nature of post-operative complications	Following the procedure (Day 0) up to 12 months	Yes
Secondary	Evaluation of operative times	Evaluation of key steps of gastric bypass surgery, OR occupation time	During the procedure (Day 0)	No
Secondary	Evaluation of direct costs	Direct costs include material used, OR occupation time, length of stay, return to normal activity	During the procedure (day 0) and up to 12 months	No
Secondary	Evaluation of indirect costs	Combination of number of patients having surgery, perception of robot-assisted surgery by both personnel and patients, publications, and communications	Up to 12 months	No