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NCT05224791 · ClinicalTrials.gov registry record
A Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastrectomy
A clinical trial of Sleeve Gastrectomy and Laparoscopic Sleeve Gastrectomy, sponsored by Methodist Health System.
- Recruiting
- Registry status
- 400
- Enrollment target
- 1
- Study location
NCT05224791 is a study of Sleeve Gastrectomy and Laparoscopic Sleeve Gastrectomy that is actively recruiting participants, run by Methodist Health System. The registered enrollment target is 400 participants, above the 115-participant average among 8 other Sleeve Gastrectomy trials with a reported enrollment target (248% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05224791, a study of Sleeve Gastrectomy and Laparoscopic Sleeve Gastrectomy, is actively recruiting participants, sponsored by Methodist Health System.
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 1
- Study location
Study 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, an
Conditions Studied
Interventions
- PROCEDURE Sleeve Gastrectomy
- PROCEDURE Roux-en-Y Gastric Bypass
Study Locations (1)
Texas
- Minimally Invasive Surgical Associates, Methodist Dallas Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2020-06-26 |
| Est. Completion | 2025-04-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05224791
The ClinicalTrials.gov registry entry for NCT05224791 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 8 other Sleeve Gastrectomy trials with a reported enrollment target (248% higher). The listed sponsor is Methodist Health System, which has 125 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sleeve Gastrectomy appearing as the primary indexed condition, and to 2 interventions - of which Sleeve Gastrectomy is the first listed.
NCT05224791 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05224791 about?
NCT05224791 is a clinical study titled "A Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastrectomy". 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 ...
What is the current status of trial NCT05224791?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2020-06-26. Estimated completion is 2025-04-08.
What conditions does trial NCT05224791 study?
This clinical trial studies the following conditions: Sleeve Gastrectomy, Laparoscopic Sleeve Gastrectomy.
What interventions are being tested in trial NCT05224791?
The interventions under investigation include: Sleeve Gastrectomy (PROCEDURE), Roux-en-Y Gastric Bypass (PROCEDURE).
Who is sponsoring clinical trial NCT05224791?
This trial is sponsored by Methodist Health System, which has 125 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05224791 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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