A Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastrectomy
1 other identifier
observational
400
1 country
1
Brief Summary
The prevalence of obesity has tripled in the last 50 years with presently about 1.7 billion of the world population aged 18 years and over either overweight or obese.1 In the US alone, 35% of the population is obese.2 Although alternative surgical approaches are available, bariatric surgery results in substantial and durable weight reduction for the majority of patients, making it the most effective treatment for severe obesity.3 In the battle to reduce the invasiveness of bariatric procedures, laparoscopy has become the gold standard approach for virtually all bariatric surgery procedures in the years since it was first used for gastric bypass by Wittgrove and colleagues in 1993.5 Available data shows perioperative patient-oriented advantages of laparoscopy when compared with open surgery, including a shorter hospital stay, decreased postoperative pain, and enhanced postoperative recovery.6 The Agency for Healthcare Research and Quality (AHRQ) reported significant improvements in the safety of metabolic/bariatric surgery due in large part to improved surgical techniques.7 The risk of death is about 0.1%8 and the overall likelihood of major complications is about 4%.9 Performing bariatric surgery laproscopically can be demanding in many situations because of large livers and substantial visceral fat that limit the working space and make exposure, dissection, and reconstruction difficult.10 Similarly, thick abdominal walls may cause excessive torque on instruments. Under such situations, surgeons' ergonomics become a serious concern.11 Use of robotics in bariatric surgery has been evolving since Cadiere and colleagues reported the first case in 1999.12 Robotic surgery has provided the surgeons with the advantage of three-dimensional vision as well as increased dexterity and precision by downscaling surgeon's movements enabling a fine tissue dissection and filtering out physiological tremor.13 It overcomes the restraint of torque on ports from thick abdominal wall, and minimizes port site trauma by remote center technology.14 Although Roux-en-Y gastric bypass (RYGB) is considered by many to be the gold standard procedure for weight loss,4 several studies demonstrate that sleeve gastrectomy (SG) and RYGB provide comparable weight loss.15 In fact, utilization of SG significantly increased from 9.3% in 2010 to 58.2% in 2014.16
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2020
CompletedFirst Submitted
Initial submission to the registry
November 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2025
CompletedMarch 28, 2024
March 1, 2024
4.8 years
November 11, 2020
March 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pre-Operative Information:
Collection of Demographics data: gender, age in years Collection of pre-operative medical history: diabetes status, cardiopulmonary disease, hypertension diagnosis, previous abdominal surgery Collection of Demographics patient characteristics: BMI, ASA Class, tobacco use
January 1, 2017 -May 2020
Intra-Operative Data:
Operative time
January 1, 2017 -May 2020
Post-Operative Data (up to discharge)
Post-operative data collection such as adverse events, discharge status, hospital length of stay, information on enhanced recovery program
January 1, 2017 -May 2020
Short-Term Follow-Up Data (up to 30 days post-discharge):
Data collection of events such as Adverse events up to 30 days, re- admissions, re-operations related to the index procedure
January 1, 2017 -May 2020
Study Arms (2)
Gastric Bypass
The RYGB connects a limb of the intestine to a much smaller stomach pouch, which prevents the bile from entering the upper part of the stomach and esophagus, thereby effectively bypassing the remaining stomach and first segment of the small intestine.
Sleeve Gastrectomy
The SG is a restrictive procedure in which a partial left gastrectomy of the fundus and body of the stomach is performed in order to create a long tubular "sleeve" along the lesser curvature. The weight loss and resolution of comorbidities are attributed not only to the restrictive nature of the procedure but also to restriction by the pylorus, decreased ghrelin, increased satiety, increased gastric emptying, and faster small bowel transit times with a component of malabsorption.
Interventions
The RYGB connects a limb of the intestine to a much smaller stomach pouch, which prevents the bile from entering the upper part of the stomach and esophagus, thereby effectively bypassing the remaining stomach and first segment of the small intestine.
The SG is a restrictive procedure in which a partial left gastrectomy of the fundus and body of the stomach is performed in order to create a long tubular "sleeve" along the lesser curvature. The weight loss and resolution of comorbidities are attributed not only to the restrictive nature of the procedure but also to restriction by the pylorus, decreased ghrelin, increased satiety, increased gastric emptying, and faster small bowel transit times with a component of malabsorption
Eligibility Criteria
This is a multi-center, retrospective chart review study of all consecutive cases of RYGB and SG, performed by participating surgeons at their respective institutions that meet the study inclusion and exclusion criteria. The chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to IRB approval of the study at the site until and going back to 2017 (i.e. most current cases in 2020 and chronologically going back through 2017). Study initiation at the participating site will occur once a research agreement has been executed between Intuitive Surgical and the participating institution/ investigator and after IRB approval has been obtained.
You may qualify if:
- Subject was 18 years or older at the time of procedure
- Subject who has undergone either laparoscopic or robotic-assisted RYGB or SG between the time frame of 30 days prior to institution's IRB approval date and the year 2017
- Subject has one of the below qualifications:
- Body mass index (BMI) \> 40 kg/m2 or more than 100 pounds overweight OR
- BMI \> 35 kg/m2 and one of the following obesity-related co-morbidities such as type II diabetes mellitus, hypertension, sleep apnea and other respiratory disorders, non- alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.
You may not qualify if:
- Subject who underwent RYGB or SG as an emergent procedure
- Subject who underwent RYGB or SG as revisional bariatric procedure
- Subject who underwent RYGB or SG as a secondary (concomitant) procedure and not as a primary procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Methodist Health Systemlead
- Intuitive Surgicalcollaborator
Study Sites (1)
Minimally Invasive Surgical Associates, Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sachin S Kukreja, MD
The Methodist Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2020
First Posted
February 4, 2022
Study Start
June 26, 2020
Primary Completion
April 8, 2025
Study Completion
April 8, 2025
Last Updated
March 28, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share