Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass
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.
|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|
- 24h postoperative pain [ Time Frame: 24h ] [ Designated as safety issue: No ]Pain assessment 24h post surgery (visual analog scale)
- 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
|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)|
Experimental: Robot-assisted surgery
Robot-assisted (da Vinci surgical system) gastric bypass
Procedure: Gastric bypass
Active Comparator: Conventional laparoscopy
Laparoscopic gastric bypass
Procedure: Gastric bypass
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760512
|Service de Chirurgie Digestive et Endocrinienne|
|Strasbourg, France, 67 000|
|Principal Investigator:||Michel Vix||Service de Chirurgie Générale et Endocrinienne - Nouvel Hôpital Civil - Strasbourg|