Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY)
Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain
Study Overview
Status
Conditions
Intervention / Treatment
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 U.S. 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ricard Corcelles Codina, MD
- Phone Number: 216-445-2665
- Email: corcelr@ccf.org
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic
-
Contact:
- Chytaine Hall
- Phone Number: 216-445-3983
- Email: hallc@ccf.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients eligible to undergo a SG 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.
Exclusion Criteria:
- patients with previous bariatric surgeries, emergency surgeries, with chronic opioid use (daily use of opioids for at least 3 months), and those who are not able to sign the written consent form.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Laparoscopic Sleeve Gastrectomy (LSG)
Sleeve Gastrectomy completed using laparoscopic technique
|
Bariatric Surgery
|
|
Active Comparator: Robotic Sleeve Gastrectomy (RSG)
Sleeve Gastrectomy completed using robot assistance
|
Bariatric Surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparing post-operative day-1 morphine equivalent dose consumption (mg)
Time Frame: 24 hours post-op
|
To determine if patients with obesity planned for robotic sleeve gastrectomy experience a decrease in opioid consumption (Morphine Equivalent Dose) in mg on postoperative day 1 compared to patients undergoing laparoscopic sleeve gastrectomy.
|
24 hours post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparing postoperative pain score
Time Frame: on postoperative days 1 (±1 days), 7 (±3 days), and 30 days (±15 days) post-op
|
Will be assessed using Numerical Rating Scale-11 (NRS-11), a patient reported outcome measure.
Scale is measured from 0-10 with 0 being the least amount of pain and 10 being the most amount of pain.
|
on postoperative days 1 (±1 days), 7 (±3 days), and 30 days (±15 days) post-op
|
|
Comparing day-7 PROMIS scores
Time Frame: 7 (±3 days) and 30 days (±15 days) post-op
|
Will be assessed using Patient Reported Outcome Measurement Information System (PROMIS) intensity pain short form 3a , a patient reported outcome measure.
The Survey has two items on remote pain (past 7 days) and one item on the pain level at the time of the questionnaire.
Each question is scored from 1-5, rating pain from "Had no pain" = 1 to "Very severe" = 5.
Accumulative score between 3-15 have corresponding T scores with high values indicating severe symptoms.
|
7 (±3 days) and 30 days (±15 days) post-op
|
|
Comparing rapid upper limb assessment (RULA) score in surgeons.
Time Frame: intraoperative
|
RULA provides an assessment of the postures of the neck, trunk, and upper limb along with muscle function and the external loads experienced by the body 16.
To use the instrument, the evaluators (independent research team member who does not operate) subjectively score posture, muscle use, and force for one side of the body at a time.
The scores are then added to obtain a grand score.
A score of 5 to 6 indicates increased risk for musculoskeletal injury, and a grand score of 7 indicates imminent risk of injury.
|
intraoperative
|
|
Improvement in Quality of life of patients
Time Frame: 30 days (±15 days) post-op
|
Change from baseline in score of The 36-Item Short Form Health Survey (SF-36) (physical and mental components).
Each item is given a score ranging from 0-100.
Lower scores indicating poor outcomes.
Final score is an average of all the items that were answered.
Unanswered questions are not included in the final average.
Research coordinator completes the survey with the patient.
|
30 days (±15 days) post-op
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day perioperative complications and serious adverse event incidence
Time Frame: 30 days (±15 days) post-op
|
Incidence of complications associated with Sleeve Gastrectomy: bleeding requiring transfusion, pulmonary adverse events, venous thromboembolism, cardiac events, renal failure requiring dialysis, gastrointestinal leak, bowel obstruction requiring surgery, gastric/anastomotic stricture or ulcer, readmission, and sepsis
|
30 days (±15 days) post-op
|
|
Length of hospital stay
Time Frame: 30 days (±15 days) post-op
|
Days spent in hospital after surgery until 30 days (±15 days) post-op
|
30 days (±15 days) post-op
|
|
Number of participants with resolution of medical comorbidities
Time Frame: one year post-op
|
Resolution of medical comorbidities associated with obesity at one year post-op Diabetes Hypertension Hyperlipidemia, hypertriglyceridemia Obstructive Sleep Apnea Non-alcoholic Fatty Liver Disease Chronic Obstructive Pulmonary Disease/asthma Stress urinary incontinence Polycystic Ovary Syndrome Degenerative join disease Pseudotumor cerebrii
|
one year post-op
|
|
weight loss in percent of weight lost (%WL)
Time Frame: post-op up to one year of follow up
|
weight loss divided by initial pre-operative weight in percent (%WL)
|
post-op up to one year of follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ricard Corcelles Codina, MD, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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