91 Participants Needed

Robotic vs Laparoscopic Sleeve Gastrectomy for Obesity

(EARLY Trial)

RC
Overseen ByRicard Corcelles Codina, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ricard Corcelles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical techniques for weight loss: laparoscopic and robotic sleeve gastrectomy. The researchers aim to determine which method results in less postoperative pain and to evaluate factors such as the surgeon's ease of use and patient quality of life. The study will also assess how well each method aids in weight loss and addresses other health issues over the following year. Suitable participants qualify for weight loss surgery based on current guidelines, can safely undergo surgery, and are not on long-term opioid medications. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance surgical techniques and patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these surgical techniques are safe for obesity treatment?

Research has shown that robotic sleeve gastrectomy (RSG) is generally safe. In one study, only 1.1% of patients experienced unwanted side effects related to the robotic system, and no deaths occurred, suggesting that the robotic method is well-tolerated.

For laparoscopic sleeve gastrectomy (LSG), studies also indicate safety with few complications. Specifically, one study reported no deaths and a leakage rate of just 1.2%, indicating that LSG is generally well-tolerated by patients.

Both methods aim to assist with weight loss and improve health, maintaining a good safety record based on past research.12345

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for obesity because they both aim to improve patient outcomes in different ways. The Robotic Sleeve Gastrectomy (RSG) uses robotic assistance to potentially offer greater precision and control during the surgery, which could lead to fewer complications and faster recovery times. Meanwhile, the Laparoscopic Sleeve Gastrectomy (LSG) is a minimally invasive technique known for smaller incisions and quicker recovery compared to traditional open surgeries. By comparing these methods, researchers hope to determine which approach offers the best balance of safety and effectiveness for patients battling obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare Robotic Sleeve Gastrectomy (RSG) with Laparoscopic Sleeve Gastrectomy (LSG) for obesity. Studies have shown that both robotic and laparoscopic sleeve gastrectomies effectively promote weight loss in people with obesity. Specifically, research indicates that robotic sleeve gastrectomy can result in a loss of about 29.5% of total body weight within a year and helps maintain weight loss over five years. Laparoscopic sleeve gastrectomy also leads to significant weight loss and can improve health issues related to obesity, though some individuals might regain weight after two years. Both treatments are effective, but the best choice depends on individual needs and circumstances.15678

Who Is on the Research Team?

RC

Ricard Corcelles Codina, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals eligible for bariatric surgery to treat obesity, as per NIH guidelines. Participants must be able to consent, be medically cleared for elective surgery, and handle general anesthesia. It's taking place at the Cleveland Clinic Bariatric and Metabolic Institute.

Inclusion Criteria

I am cleared for surgery according to NIH guidelines and can undergo anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either laparoscopic or robotic sleeve gastrectomy

1 week
1 visit (in-person for surgery)

Postoperative Monitoring

Participants are monitored for early postoperative pain and other outcomes

4 weeks
3 visits (in-person or virtual) on postoperative days 1, 7, and 30

Follow-up

Participants are monitored for resolution of medical comorbidities and weight loss

1 year
Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Laparoscopic Sleeve Gastrectomy
  • Robotic Sleeve Gastrectomy
Trial Overview The study compares two types of weight loss surgeries: traditional Laparoscopic Sleeve Gastrectomy (LSG) and Robotic Sleeve Gastrectomy (RSG). The main focus is on postoperative pain but also looks at surgeon comfort during operation and patient life quality after surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Laparoscopic Sleeve Gastrectomy (LSG)Experimental Treatment1 Intervention
Group II: Robotic Sleeve Gastrectomy (RSG)Active Control1 Intervention

Laparoscopic Sleeve Gastrectomy is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Laparoscopic Sleeve Gastrectomy for:
🇪🇺
Approved in European Union as Laparoscopic Sleeve Gastrectomy for:
🇨🇦
Approved in Canada as Laparoscopic Sleeve Gastrectomy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ricard Corcelles

Lead Sponsor

Trials
1
Recruited
90+

Published Research Related to This Trial

Robotic laparoscopic sleeve gastrectomy (LSG) is a safe and effective method for treating morbid obesity, with no peri-operative complications reported in a study of 19 patients.
The procedure demonstrated a mean excess body weight loss of 65.5% one year post-surgery, and the operating time was comparable to traditional LSG techniques, indicating that robotic assistance does not prolong the surgery.
Initial experience with robotic sleeve gastrectomy for morbid obesity.Diamantis, T., Alexandrou, A., Nikiteas, N., et al.[2021]
In a study of 3552 patients undergoing robotic gastrectomy (RG) or laparoscopic gastrectomy (LG) for gastric cancer, RG showed a lower overall complication rate (12.6% vs 15.2%) and less blood loss compared to LG, indicating RG may be safer in the short term.
Both RG and LG had comparable long-term oncological outcomes, suggesting that RG is an effective alternative to LG for gastric cancer treatment, despite concerns about longer operation times and higher costs.
Robotic Gastrectomy Versus Laparoscopic Gastrectomy for Gastric Cancer: A Multicenter Cohort Study of 5402 Patients in China.Li, ZY., Zhou, YB., Li, TY., et al.[2023]
In a study of over 72,000 sleeve gastrectomy procedures, robot-assisted sleeve gastrectomy (RSG) was associated with a higher likelihood of conversion to open surgery (2.3% vs 0.2% for laparoscopic sleeve gastrectomy (LSG)) and a longer average hospital stay (2.1 days vs 1.8 days for LSG).
RSG patients experienced higher hospital charges, with average costs of $47,623 for the initial admission and $57,484 cumulatively in the year following surgery, compared to $35,934 and $43,769 for LSG patients, respectively, indicating no clear advantages of robotic assistance in terms of safety or efficacy.
Outcomes following robot-assisted versus laparoscopic sleeve gastrectomy: the New York State experience.Burstein, MD., Myneni, AA., Towle-Miller, LM., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37606806/
Long-Term Outcome of Laparoscopic Sleeve Gastrectomy ...This study aimed to present our long-term laparoscopic sleeve gastrectomy (LSG) efficacy in terms of weight loss and obesity-related complications resolution.
Long-term outcomes of laparoscopic sleeve gastrectomyLong-term follow-up reveals a tendency to weight regain after approximately 2 years from primary surgery, with the need for revisional surgery in some cases.
Laparoscopic Sleeve Gastrectomy Versus Roux-Y-Gastric.. ...In this trial, LSG and LRYGB are equally efficient regarding weight loss, quality of life, and complications up to 3 years postsurgery.
Comparing long-term outcomes between laparoscopic ...The aim of this study is to compare the degree of long-term weight loss, remission of co-morbidities and complication rates following LRYGB and LSG procedures.
Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y ...In this 10-year follow-up of a randomized clinical trial including 240 patients, both LSG and LRYGB resulted in good and sustainable weight loss.
Five-year outcomes of laparoscopic sleeve gastrectomy as ...In this study, a standardized LSG proved to be safe (no mortality and a leakage rate of 1.2%) and highly effective in terms of weight loss after 5-year of ...
Safety and effectiveness of reduced-port laparoscopic ...In this study, we found that SPSG and RPSG showed weight loss outcomes similar to CLSG. The groups were similar throughout the follow-up period ...
unveiling long-term weight and co-morbidity outcomes up ...LSG demonstrates sustained weight loss and resolution of comorbidities with low complication rates. The influence of initial obesity class on ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security