Sleeve Gastrectomy vs Knee Replacement Surgery for Obesity

Recruiting at 1 trial location

Overseen By Jack A Kerr, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial University of Newfoundland

Disqualifiers: Revision surgery, Neoplastic disease, Mental illness, others

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

Compensation: Varies

Number of Visits: 3

142 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether 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 laparoscopic sleeve gastrectomy for obesity?

Laparoscopic sleeve gastrectomy has been shown to lead to significant weight loss and improvement in obesity-related health issues, with studies indicating its effectiveness in both adolescents and adults over long-term follow-ups. ^{1 2 3 4 5}

Is sleeve gastrectomy generally safe for humans?

Sleeve gastrectomy is considered a safe procedure for treating obesity, with studies showing it can be performed safely even in high-risk patients and those with certain medical conditions. However, it is important to note that it is an irreversible procedure, and long-term safety data is still being gathered. ^{5 6 7 8 9}

How does laparoscopic sleeve gastrectomy differ from other treatments for obesity?

Laparoscopic sleeve gastrectomy is unique because it involves removing a large portion of the stomach, which reduces food intake and may also affect hunger hormones, unlike other procedures like gastric bypass that reroute the digestive system. It offers significant weight loss with fewer long-term malabsorptive risks, making it a popular choice for both adults and adolescents with obesity. ^{2 10 11 12 13}

What is the purpose of this trial?

The goal of this study is to determine whether undergoing bariatric surgery before knee replacement leads to better outcomes compared to undergoing knee replacement before bariatric surgery. Our secondary goal is to compare complication rates between these groups to determine if there is a difference based on the order of the two procedures. Participants will be randomly placed in one of two groups, with each undergoing both procedures but in opposite order. Quality of life will be assessed via questionnaires before and between each procedure, and rates of complications will also be documented to compare their rates between groups.

Eligibility Criteria

This trial is for adults with severe knee osteoarthritis and morbid obesity who haven't had bariatric surgery or knee replacement before. Participants should be fit enough for both surgeries. Those with other significant health issues, previous stomach or knee surgeries, or conditions affecting their ability to follow the study protocol are excluded.

Inclusion Criteria

My BMI is 35 or higher and I am on a waitlist for knee and weight loss surgery.

Exclusion Criteria

My health issues do not severely limit my daily activities.

History of significant mental illness

I have had surgery on my esophagus or stomach before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

First Procedure

Participants undergo either total knee arthroplasty or laparoscopic sleeve gastrectomy as the first procedure

1 year

Regular follow-up visits as per standard surgical protocol

Second Procedure

Participants undergo the second procedure, either laparoscopic sleeve gastrectomy or total knee arthroplasty, depending on the initial assignment

1 year

Regular follow-up visits as per standard surgical protocol

Follow-up

Participants are monitored for safety and effectiveness after both procedures

12 months

Surveillance every 3 months post-procedure

Treatment Details

Interventions

• laparoscopic sleeve gastrectomy
• total knee arthroplasty

Trial Overview The study aims to find out if it's better to have weight loss surgery (laparoscopic sleeve gastrectomy) before a knee replacement (total knee arthroplasty), or vice versa. Patients will be randomly assigned to one of two groups, each receiving the surgeries in a different order.

Participant Groups

Group I: Knee Arthroplasty then Sleeve Gastrectomy Active Control 2 Interventions

Participants in this arm will undergo total knee arthroplasty followed by laparoscopic sleeve gastrectomy at least 1 year following the first procedure.

Group II: Sleeve Gastrectomy then Knee Arthroplasty Active Control 2 Interventions

Participants in this arm will undergo laparoscopic sleeve gastrectomy followed by a total knee arthroplasty at least 1 year following the first procedure.

Who Is Running the Clinical Trial?

Memorial University of Newfoundland

Lead Sponsor

Trials

73

Recruited

1,836,000+

Findings from Research

In a study of 3287 patients, both sleeve gastrectomy (SG) and gastric bypass (GB) were effective in treating obesity and its related health issues, with significant improvements in quality of life observed after both procedures.

SG had a lower complication rate and fewer nutritional deficiencies compared to GB, making it a safer option, especially for patients with a healthier metabolic profile, despite GB showing slightly better remission rates for hypertension and dyslipidemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes of sleeve gastrectomy versus gastric bypass: first report based on Tehran obesity treatment study (TOTS). Khalaj, A., Tasdighi, E., Hosseinpanah, F., et al.[2020]

In a study of 38,153 bariatric surgery patients, sleeve gastrectomy was associated with fewer re-interventions (9.9% vs. 15.6%) and complications (6.6% vs. 9.6%) compared to gastric bypass after 2 years, indicating a better safety profile for sleeve gastrectomy.

Despite its overall safety advantages, sleeve gastrectomy had a slightly higher rate of revisions (0.6% vs. 0.4%) compared to gastric bypass, suggesting that while it is safer, the risk of needing further surgery should be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Safety of Sleeve Gastrectomy and Gastric Bypass: An Instrumental Variables Approach. Chhabra, KR., Telem, DA., Chao, GF., et al.[2022]

Both laparoscopic gastric bypass and laparoscopic sleeve gastrectomy effectively reduced BMI and improved diabetic conditions in overweight and obese patients with type-2 diabetes, with significant improvements in various metabolic markers post-surgery.

Laparoscopic sleeve gastrectomy was associated with shorter surgery times and less intraoperative blood loss compared to gastric bypass, making it a potentially safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of laparoscopic gastric bypass vs laparoscopic sleeve gastrectomy in treating obesity combined with type-2 diabetes. Yan, Y., Wang, F., Chen, H., et al.[2022]

Laparoscopic sleeve gastrectomy (LSG) is a safe and effective weight-loss surgery, showing significant weight loss of approximately 89.3 lb after one year and 87.5 lb after two years in patients, with a low complication rate (only 12 complications reported, including one death).

The procedure also led to a high rate of diabetes resolution, with 82% of diabetic patients cured and others experiencing reduced medication needs, indicating its potential metabolic benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results. Jacobs, M., Bisland, W., Gomez, E., et al.[2021]

References

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

Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial. [2022]

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

Laparoscopic vertical sleeve gastrectomy for adolescents with morbid obesity. [2014]

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

Long term predictors of success after laparoscopic sleeve gastrectomy. [2014]

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

Long-Term Outcome of Laparoscopic Sleeve Gastrectomy (LSG) on Weight Loss in Patients with Obesity: a 5-Year and 11-Year Follow-Up Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Two-year outcomes of sleeve gastrectomy versus gastric bypass: first report based on Tehran obesity treatment study (TOTS). [2020]

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

Comparative Safety of Sleeve Gastrectomy and Gastric Bypass: An Instrumental Variables Approach. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of laparoscopic gastric bypass vs laparoscopic sleeve gastrectomy in treating obesity combined with type-2 diabetes. [2022]

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

A Multimodal Analgesic Protocol Reduces Opioid-Related Adverse Events and Improves Patient Outcomes in Laparoscopic Sleeve Gastrectomy. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Sleeve gastrectomy as a single-stage bariatric operation: indications and limitations. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results. [2021]

11. France pubmed.ncbi.nlm.nih.gov

Evolution of low-grade systemic inflammation, insulin resistance, anthropometrics, resting energy expenditure and metabolic syndrome after bariatric surgery: a comparative study between gastric bypass and sleeve gastrectomy. [2017]

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

Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. [2022]

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

Evaluation of laparoscopic sleeve gastrectomy on weight loss and co-morbidity. [2022]