This will be a prospective, obesity-registry based, single-blind randomized controlled trial with a 1:1 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.
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.
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.
Parallel
Laparoscopic Sleeve Gastrectomy (LSG)
Procedure/SurgeryBariatric Surgery
Robotic Sleeve Gastrectomy (RSG)
Procedure/SurgeryBariatric Surgery
Comparing post-operative day-1 morphine equivalent dose consumption (mg)
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.
Comparing postoperative pain score
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.
Comparing day-7 PROMIS scores
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.
Comparing rapid upper limb assessment (RULA) score in surgeons.
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.
Improvement in Quality of life of patients
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-day perioperative complications and serious adverse event incidence
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
Length of hospital stay
Days spent in hospital after surgery until 30 days (±15 days) post-op
Number of participants with resolution of medical comorbidities
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
weight loss in percent of weight lost (%WL)
weight loss divided by initial pre-operative weight in percent (%WL)
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Ricard Corcelles
Lead sponsor
The Cleveland Clinic
Sponsor institution
