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)

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Robotic vs Laparoscopic Sleeve Gastrectomy for Obesity?

Research shows that both robotic and laparoscopic sleeve gastrectomy are effective for treating obesity, with laparoscopic sleeve gastrectomy being the more commonly used procedure. Robotic sleeve gastrectomy is an alternative that may offer technical advantages, especially in very obese patients.12345

Is robotic or laparoscopic sleeve gastrectomy safe for humans?

Both robotic and laparoscopic sleeve gastrectomy are generally considered safe for treating obesity, with studies showing no significant differences in complications between the two methods. However, there is limited evidence on long-term outcomes for robotic sleeve gastrectomy, and some studies suggest slightly higher reoperation rates for certain conditions.14678

How does robotic sleeve gastrectomy differ from laparoscopic sleeve gastrectomy for obesity?

Robotic sleeve gastrectomy (RSG) uses a robotic platform, like the da Vinci system, which may offer technical advantages in surgery, especially for very obese patients, compared to the more commonly used laparoscopic sleeve gastrectomy (LSG). While both aim to reduce stomach size to help with weight loss, the robotic approach is less frequently used and may provide more precision and control during the procedure.145910

Research Team

RC

Ricard Corcelles Codina, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Laparoscopic Sleeve Gastrectomy (LSG)Experimental Treatment1 Intervention
Sleeve Gastrectomy completed using laparoscopic technique
Group II: Robotic Sleeve Gastrectomy (RSG)Active Control1 Intervention
Sleeve Gastrectomy completed using robot assistance

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:
  • Obesity
  • Severe obesity with comorbidities
🇪🇺
Approved in European Union as Laparoscopic Sleeve Gastrectomy for:
  • Obesity
  • Severe obesity with comorbidities
🇨🇦
Approved in Canada as Laparoscopic Sleeve Gastrectomy for:
  • Obesity
  • Severe obesity with comorbidities

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ricard Corcelles

Lead Sponsor

Trials
1
Recruited
90+

Findings from Research

Robotic sleeve gastrectomy (RSG) has a longer operative time and is associated with higher rates of serious complications, including leaks and surgical site infections, compared to laparoscopic sleeve gastrectomy (LSG).
Despite similar lengths of hospital stay and no significant difference in 30-day mortality rates between RSG and LSG, the increased morbidity associated with RSG suggests that laparoscopic techniques should remain the preferred method for sleeve gastrectomy.
Robotic versus laparoscopic sleeve gastrectomy: a MBSAQIP analysis.Fazl Alizadeh, R., Li, S., Inaba, CS., et al.[2020]
Robotic gastrectomy (RG) demonstrated significant advantages over laparoscopic gastrectomy (LG) in treating gastric cancer, including shorter operative times (201 min for RG vs. 231 min for LG) and less blood loss (13 mL for RG vs. 42 mL for LG).
Patients undergoing RG experienced lower postoperative morbidity (1.0% for RG vs. 4.8% for LG) and shorter hospital stays, indicating that RG is a safer and more efficient option for gastric cancer surgery.
Comparison of robotic gastrectomy and laparoscopic gastrectomy for gastric cancer: a propensity score-matched analysis.Omori, T., Yamamoto, K., Hara, H., et al.[2022]
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]

References

Robotic versus laparoscopic sleeve gastrectomy: a MBSAQIP analysis. [2020]
Comparison of robotic gastrectomy and laparoscopic gastrectomy for gastric cancer: a propensity score-matched analysis. [2022]
Robotic Gastrectomy Versus Laparoscopic Gastrectomy for Gastric Cancer: A Multicenter Cohort Study of 5402 Patients in China. [2023]
A comparative retrospective study of robotic sleeve gastrectomy vs robotic gastric bypass. [2022]
Perioperative Outcomes of Robotic Versus Laparoscopic Sleeve Gastrectomy in the Super-obese. [2020]
Safety assessment of robotic gastrectomy and analysis of surgical learning process: a multicenter cohort study. [2022]
Outcomes following robot-assisted versus laparoscopic sleeve gastrectomy: the New York State experience. [2022]
Operative and Postoperative Complications of Laparoscopic Sleeve Gastrectomy in Super and Nonsuper Obese Patients: A Center of Excellence Experience Comparative Study. [2021]
Laparoscopic hand-assisted versus robotic-assisted laparoscopic sleeve gastrectomy: experience of 103 consecutive cases. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Initial experience with robotic sleeve gastrectomy for morbid obesity. [2021]
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