Sleeve Gastrectomy vs Knee Replacement Surgery for Obesity

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether undergoing weight loss surgery or knee surgery first leads to better outcomes for individuals with obesity and knee issues. Participants will either have a sleeve gastrectomy (a type of weight loss surgery) followed by knee replacement, or the reverse order, to determine which sequence enhances quality of life and reduces complications. It is ideal for individuals with a BMI of 35 or higher who are already on the waitlist for both surgeries. As an unphased trial, participants contribute to valuable research that may improve surgical outcomes for others facing similar health challenges.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that laparoscopic sleeve gastrectomy (LSG) is generally safe for people with obesity. Studies have found that this surgery aids in weight loss and enhances quality of life. However, like any surgery, it carries some risks. Early complications may include bleeding and leaks from the stomach incision and staples. Later issues can include acid reflux, which causes a burning sensation in the chest.

Overall, LSG is well-tolerated and provides good long-term weight loss results. Many patients experience lasting health improvements and feel better after the surgery. While risks exist, they are well-known and can often be managed by doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the sequence of laparoscopic sleeve gastrectomy and knee arthroplasty for managing obesity-related joint issues. Unlike typical treatments that address obesity or joint pain separately, this approach combines both, aiming to enhance overall patient outcomes. The sleeve gastrectomy is a minimally invasive procedure that reduces stomach size to promote weight loss, which can significantly ease pressure on knee joints. By potentially reducing body weight before knee replacement, this strategy could improve surgical recovery and long-term joint function. This innovative sequence might offer a comprehensive solution for patients struggling with obesity and its impact on joint health.

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

This trial will compare the sequence of laparoscopic sleeve gastrectomy and total knee arthroplasty for individuals with obesity. Studies have shown that laparoscopic sleeve gastrectomy, one of the procedures in this trial, effectively treats obesity. It enables significant weight loss, which patients maintain for at least five years post-surgery. This surgery is particularly effective for individuals with a body mass index (BMI) over 40. Research also indicates that it is a safe procedure, with very few complications, such as leakage. Overall, bariatric surgery, including sleeve gastrectomy, is considered one of the best options for managing severe obesity. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

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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 ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1015958424012697

Comparing long-term outcomes between laparoscopic ...

In recent studies, both LRYGB and LSG have shown good long-term (≥5 years) results in terms of %TWL and %EWL in morbid obesity patients (BMI>40 kg/m2).

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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 ...

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Bariatric surgery is the most effective treatment for managing morbid obesity, leading to satisfactory long-term weight loss and a significant ...

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pubmed.ncbi.nlm.nih.gov

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Long-term outcomes of laparoscopic sleeve gastrectomy in ...

Those with class I obesity who undergo LSG experience normalization of weight, sustained remission of co-morbidity, and good quality of life

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8035819/

Safety and Outcomes of Laparoscopic Sleeve Gastrectomy ...

Early adverse events include hemorrhage, leakage from the staple line and sleeve stricture, while reported late complications are gastroesophageal reflux and ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1550728918301229

Safety and short-term outcomes of laparoscopic sleeve ...

The aim of this study was to demonstrate that LSG is safe and effective for patients>65 years old with severe obesity. Setting. Department of Minimally Invasive ...

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jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/2793539

Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y ...

In the Sleeve vs Bypass (SLEEVEPASS) trial, at 5 and 7 years after surgery, both LSG and LRYGB resulted in good weight loss outcomes, similar ...