Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425016
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-24
Brief Title:
Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy
Sponsor:
Ricard Corcelles
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy EARLY A Randomized Controlled Trial on Early Postoperative Pain
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EARLY
Brief Summary:
This will be a prospective obesity-registry based single-blind randomized controlled trial with a 11 allocation ratio Specific inclusion criteria are all patients eligible to undergo a Laparoscopic sleeve gastrectomy LSG based on the current National Institute of Health NIH patient selection guidelines Patients should be able to give consent be deemed medically-cleared to undergo elective surgery and tolerate general anesthesia All enrollments and surgeries in this study will take place at the Cleveland Clinic Bariatric and Metabolic Institute The study will consist of 2 interventions laparoscopic sleeve gastrectomy LSG or robotic sleeve gastrectomy RSG The primary objective is early postoperative pain but also surgeon ergonomics and patient quality of life will be compared Additional outcomes include 30-day perioperative results minor and major morbidities serious adverse events resolution of medical comorbidities and weight loss in percent of excess weight lost EWL at one year
Detailed Description:
Currently bariatric surgery is the most effective long-term treatment for severe obesity Bariatric surgery results in sustained weight loss improved quality of life and amelioration of obesity-related comorbidities Laparoscopic sleeve gastrectomy LSG has become increasingly popular over the past decade due to its safety profile and excellent long-term efficacy and is now the most common bariatric operation being performed in the US LSG entails resecting the greater curvature and fundus of the stomach the partial gastrectomy is oriented vertically parallel to the lesser curvature of the stomach Overall LSG results in excellent weight loss and remission of most obesity-related comorbidities LSG is also less morbid than some of the other bariatric operations such as laparoscopic Roux-en-Y gastric bypass LRYGB because of its technical simplicity and its limited alteration of the normal anatomy
Unfortunately laparoscopic surgery is not exempt from limitations including loss of freedom in a narrow abdominal cavity limited rotational movements reduced depth perception 2D video system and considerable ergonomic challenges These limitations have led to an increase in the adoption of robotic surgery In recent years robotic surgery has been employed in different specialties including metabolic and bariatric surgery Robotic surgery confers multiple advantages including better visualization 3D vision and wrist movements that are particularly helpful in bariatric procedures In addition the position of the head and the body of the operating surgeon at the robot console provides excellent ergonomic advantages
Until now the utilization of robotic surgery in bariatrics remains controversial While prospective trials are lacking retrospective data on robotic bariatric surgery have demonstrated a potential reduction in hospital length of stay LOS and postoperative morbidity compared to the standard laparoscopic approach Laparoscopy is currently considered the gold standard surgical approach for Sleeve Gastrectomy SG However laparoscopic bariatric surgery can be particularly painful in the early postoperative period and one study reported 75 of patients in the post anesthesia care unit PACU reporting moderate to severe pain The introduction of the robotic platform allows for several potential advantages versus the laparoscopic technique when performing SG One advantage is the avoidance of port torque and subsequent abdominal wall trauma which is often implicated as a source of post-operative pain following procedures Two elements less postoperative bleeding and abdominal wall trauma could potentially contribute to the lower postoperative pain reported in some recent studies of robotic surgery
Even with the rapid adoption of robotic technology for SG in the United States to date no prospective head-to-head trials have been performed The investigators hypothesize that the robotic approach to perform a SG would provide a measurable clinical benefit in regard to early postoperative pain compared to the traditional laparoscopic technique The expected outcome in the study is a significant decrease in early postoperative pain with the robotic group
Unfortunately laparoscopic surgery is not exempt from limitations including loss of freedom in a narrow abdominal cavity limited rotational movements reduced depth perception 2D video system and considerable ergonomic challenges These limitations have led to an increase in the adoption of robotic surgery In recent years robotic surgery has been employed in different specialties including metabolic and bariatric surgery Robotic surgery confers multiple advantages including better visualization 3D vision and wrist movements that are particularly helpful in bariatric procedures In addition the position of the head and the body of the operating surgeon at the robot console provides excellent ergonomic advantages
Until now the utilization of robotic surgery in bariatrics remains controversial While prospective trials are lacking retrospective data on robotic bariatric surgery have demonstrated a potential reduction in hospital length of stay LOS and postoperative morbidity compared to the standard laparoscopic approach Laparoscopy is currently considered the gold standard surgical approach for Sleeve Gastrectomy SG However laparoscopic bariatric surgery can be particularly painful in the early postoperative period and one study reported 75 of patients in the post anesthesia care unit PACU reporting moderate to severe pain The introduction of the robotic platform allows for several potential advantages versus the laparoscopic technique when performing SG One advantage is the avoidance of port torque and subsequent abdominal wall trauma which is often implicated as a source of post-operative pain following procedures Two elements less postoperative bleeding and abdominal wall trauma could potentially contribute to the lower postoperative pain reported in some recent studies of robotic surgery
Even with the rapid adoption of robotic technology for SG in the United States to date no prospective head-to-head trials have been performed The investigators hypothesize that the robotic approach to perform a SG would provide a measurable clinical benefit in regard to early postoperative pain compared to the traditional laparoscopic technique The expected outcome in the study is a significant decrease in early postoperative pain with the robotic group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None