Robotic vs Laparoscopic Sleeve Gastrectomy for Obesity

(EARLY Trial)

Overseen By Ricard Corcelles Codina, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ricard Corcelles

Must not be taking: Opioids

Disqualifiers: Previous bariatric surgeries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 week

91 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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. ^{1 4 5 9 10}

Research Team

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

Group I: Laparoscopic Sleeve Gastrectomy (LSG) Experimental Treatment 1 Intervention

Sleeve Gastrectomy completed using laparoscopic technique

Group II: Robotic Sleeve Gastrectomy (RSG) Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 299 patients (134 robotic sleeve gastrectomy and 165 robotic gastric bypass), robotic sleeve gastrectomy (RSG) was found to have shorter surgical times and fewer long-term complications compared to robotic gastric bypass (RGB).

Both procedures had similar rates of perioperative complications and effective weight loss at one year, indicating that RSG may be a safer and more efficient option than RGB in robotic bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative retrospective study of robotic sleeve gastrectomy vs robotic gastric bypass. Kosanovic, R., Romero, RJ., Donkor, C., et al.[2022]

In a study of 61,493 superobese patients undergoing either robotic-assisted sleeve gastrectomy (RSG) or laparoscopic sleeve gastrectomy (LSG), RSG was found to have a longer operative time and hospital stay compared to LSG, suggesting it may not be more efficient.

RSG was associated with a significantly higher risk of organ-space surgical site infections, raising concerns about the safety and effectiveness of robotic surgery in superobese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Outcomes of Robotic Versus Laparoscopic Sleeve Gastrectomy in the Super-obese. Nasser, H., Ivanics, T., Ranjal, RS., et al.[2020]

Robotic gastrectomy (RG) for gastric cancer was found to be safe in clinical practice, with no conversions to open surgery or in-hospital mortality among 336 patients studied from January 2017 to October 2019.

Surgeons' initial experience with RG showed lower morbidity rates in the first five cases despite longer operative times and increased fatigue, indicating that RG can be safely introduced into surgical practice with proper training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assessment of robotic gastrectomy and analysis of surgical learning process: a multicenter cohort study. Shimoike, N., Nishigori, T., Yamashita, Y., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes following robot-assisted versus laparoscopic sleeve gastrectomy: the New York State experience. Burstein, MD., Myneni, AA., Towle-Miller, LM., et al.[2022]

Laparoscopic sleeve gastrectomy (LSG) is a safe surgical option for both morbid-obese (MO) and super-morbid-obese (SMO) patients, with no significant differences in operative or postoperative complication rates between the two groups, based on a study of 713 patients from 2008 to 2017.

However, the study found that long-term reoperation and complication rates were higher in the MO group compared to the SMO group, indicating that while LSG is generally safe, morbidly obese patients may face more challenges post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operative and Postoperative Complications of Laparoscopic Sleeve Gastrectomy in Super and Nonsuper Obese Patients: A Center of Excellence Experience Comparative Study. Vilallonga, R., Hidalgo, M., Garcia Ruiz de Gordejuela, A., et al.[2021]

Robotic-assisted laparoscopic sleeve gastrectomy (RALSG) shows low perioperative complication rates and comparable weight loss to traditional laparoscopic sleeve gastrectomy (LASG), based on a study of 108 patients.

While the mean percentage estimated weight loss was greater in the robotic group at 3 and 6 months, the differences were not statistically significant, suggesting that RALSG is a safe alternative to LASG with similar outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic hand-assisted versus robotic-assisted laparoscopic sleeve gastrectomy: experience of 103 consecutive cases. Kannan, U., Ecker, BL., Choudhury, R., et al.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with robotic sleeve gastrectomy for morbid obesity. Diamantis, T., Alexandrou, A., Nikiteas, N., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Robotic versus laparoscopic sleeve gastrectomy: a MBSAQIP analysis. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Comparison of robotic gastrectomy and laparoscopic gastrectomy for gastric cancer: a propensity score-matched analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Robotic Gastrectomy Versus Laparoscopic Gastrectomy for Gastric Cancer: A Multicenter Cohort Study of 5402 Patients in China. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A comparative retrospective study of robotic sleeve gastrectomy vs robotic gastric bypass. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Perioperative Outcomes of Robotic Versus Laparoscopic Sleeve Gastrectomy in the Super-obese. [2020]

6. Japan pubmed.ncbi.nlm.nih.gov

Safety assessment of robotic gastrectomy and analysis of surgical learning process: a multicenter cohort study. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Outcomes following robot-assisted versus laparoscopic sleeve gastrectomy: the New York State experience. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Operative and Postoperative Complications of Laparoscopic Sleeve Gastrectomy in Super and Nonsuper Obese Patients: A Center of Excellence Experience Comparative Study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic hand-assisted versus robotic-assisted laparoscopic sleeve gastrectomy: experience of 103 consecutive cases. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Initial experience with robotic sleeve gastrectomy for morbid obesity. [2021]