Clinical trial NCT06425016: Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy
Official title: Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Laparoscopic Sleeve Gastrectomy
Robotic Sleeve Gastrectomy
Obesity
Bariatric Surgery Candidate
Quality of Life
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized controlled trial with a 1:1 allocation ratio. The study will consist of 2 interventions: laparoscopic sleeve gastrectomy (LSG) or robotic sleeve gastrectomy (RSG). All patients will be randomized during the preoperative evaluation process. An interim analysis will be performed upon completion of the primary endpoint assessment for 91 patients to determine whether a re-estimation of the total is required. Sample size re-estimation will be planned using the conditional power method proposed by Mehta and Pocock. The 91 patients data will be used to estimate the conditional power for detecting the difference in primary outcome between two groups in the final analysis. When the conditional power is between 0.36 and 0.8, the investigators will increase the sample size accordingly, up to a sample size of 360. Otherwise, the trial will continue using the planned sample size.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparing post-operative day-1 morphine equivalent dose consumption (mg)
timeFrame: 24 hours post-op
Secondary outcomes:
measure: Comparing postoperative pain score
timeFrame: on postoperative days 1 (±1 days), 7 (±3 days), and 30 days (±15 days) post-op
measure: Comparing day-7 PROMIS scores
timeFrame: 7 (±3 days) and 30 days (±15 days) post-op
measure: Comparing rapid upper limb assessment (RULA) score in surgeons.
timeFrame: intraoperative
measure: Improvement in Quality of life of patients
timeFrame: 30 days (±15 days) post-op
Other outcomes:
measure: 30-day perioperative complications and serious adverse event incidence
timeFrame: 30 days (±15 days) post-op
measure: Length of hospital stay
timeFrame: 30 days (±15 days) post-op
measure: Number of participants with resolution of medical comorbidities
timeFrame: one year post-op
measure: weight loss in percent of weight lost (%WL)
timeFrame: post-op up to one year of follow up
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ricard Corcelles Codina, MD
role: PRINCIPAL_INVESTIGATOR
References: