Recruiting

Laparoscopic & Robotic-Assisted

Sponsor:

Methodist Health System

Code:

NCT05224791

Conditions

Laparoscopic Sleeve Gastrectomy

Sleeve Gastrectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Roux-en-Y Gastric Bypass

Sleeve Gastrectomy

Study Details

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

Conditions

Laparoscopic Sleeve Gastrectomy

Sleeve Gastrectomy

Study ID

NCT05224791

Start date

Jun 26, 2020

Status verified date

Mar, 2024

Completion date

Apr 8, 2025

Anticipated

Primary completion date

Apr 8, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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:

1. Body mass index (BMI) > 40 kg/m2 or more than 100 pounds overweight OR
2. 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Roux-en-Y 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

Primary outcome measure

  • Pre-Operative Information: [ Time Frame: January 1, 2017 -May 2020 ]
  • Intra-Operative Data: [ Time Frame: January 1, 2017 -May 2020 ]
  • Post-Operative Data (up to discharge) [ Time Frame: January 1, 2017 -May 2020 ]
  • Short-Term Follow-Up Data (up to 30 days post-discharge): [ Time Frame: January 1, 2017 -May 2020 ]

Central Contacts and Locations

Locations

Minimally Invasive Surgical Associates, Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

Principal Investigator:

Sachin S Kukreja, MD

More Information

Sponsor

Methodist Health System

Last update posted

Mar 28, 2024

Last verified

Mar, 2024

Keywords

  • Sleeve Gastrectomy
  • laparoscopic
  • robotic-assisted RYGB

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Methodist Health System on 2024-03-28.