Weight Loss Surgery Outcomes for Obesity

Overseen by Michael Feizbakhsh, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dr. Feiz & Associates

Disqualifiers: Pregnancy, BMI below 30, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies the effects of weight loss surgery on patients who do not have other weight-related health problems. The surgery helps people lose weight by making their stomach smaller or changing how their body digests food. Researchers want to see how this surgery affects their health, mood, quality of life, and emotional well-being.

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 this treatment for weight loss surgery outcomes for obesity?

Research shows that weight loss surgery can lead to significant weight loss and improvement in obesity-related health problems, enhancing quality of life. Surgery is currently the most effective option for substantial weight loss in people with severe obesity, as it often results in better health and longer life. ^{1 2 3 4 5}

Is weight loss surgery generally safe for humans?

Weight loss surgery, also known as bariatric or metabolic surgery, has been studied extensively for safety. Serious complications occur in 1-4% of patients, and the risk of death has decreased significantly to 0.04-0.3%. However, nutritional and metabolic issues can arise long after surgery, and older patients may face higher risks of complications. ^{6 7 8 9 10}

How does weight loss surgery differ from other treatments for obesity?

Weight loss surgery, also known as bariatric or metabolic surgery, is unique because it not only helps with significant weight loss but also improves or resolves obesity-related health issues, such as type 2 diabetes, often before substantial weight loss occurs. Unlike other treatments, it is currently the most effective long-term solution for morbid obesity and its associated health problems. ^{1 5 11 12 13}

Research Team

Michael Feizbakhsh, MD

Principal Investigator

Dr. Feiz and Associates

Eligibility Criteria

This trial is for individuals with a BMI between 30 and 34.5 who are healthy enough for cosmetic weight loss surgery but don't have other health issues like diabetes or high blood pressure. Participants must be able to give informed consent and follow study procedures.

Inclusion Criteria

Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with the requirements of the study

My BMI is between 30 and 34.5, and I am cleared for weight loss surgery without any other health issues.

Exclusion Criteria

I am not cleared for weight loss surgery due to medical reasons.

Patients who are pregnant

Patients with BMI above 34.5 kg/m2

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo weight loss surgery

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for changes in health, mood, quality of life, health satisfaction, and emotional health

12 months

4 visits (in-person) at 1, 3, 6, and 12 months post-operatively

Treatment Details

Interventions

• Body Image/Self-Esteem Questionnaires (Behavioural Intervention)
• Weight Loss Surgery (Bariatric Surgery)

Trial Overview The study aims to assess patient-reported outcomes after weight loss surgery in low-risk patients, focusing on changes in health, mood, quality of life, satisfaction with their health status, and emotional well-being.

Participant Groups

Group I: Patients with BMI between 30-34.5 kg/m2 Experimental Treatment 1 Intervention

Patients with BMI between 30-34.5 kg/m2 will be administered a body image/self-esteem questionnaire pre-operatively and at 1 month, 3 months, 6 months and 12 months post-operatively.

Weight Loss Surgery is already approved in Canada for the following indications:

Approved in Canada as Bariatric Surgery for:

• Obesity with BMI ≥ 40 kg/m²
• Obesity with BMI ≥ 35 kg/m² and at least one obesity-related comorbidity

Who Is Running the Clinical Trial?

Dr. Feiz & Associates

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

Surgical weight loss procedures significantly improve or resolve obesity-related medical issues for most patients, but the long-term effects on sustained weight loss and health improvements are still uncertain.

The American Society of Bariatric Surgery's new computer registry aims to standardize outcome analysis and improve patient selection for surgeries, which could enhance the effectiveness of weight loss interventions and ultimately improve health outcomes for morbidly obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of obesity surgery. Brolin, RE.[2005]

In a study of 47 patients who underwent videolaparoscopic sleeve gastrectomy, the average percentage of excess weight loss was 85.46%, indicating significant weight reduction post-surgery.

Quality of life improvements were substantial, with 76.6% of patients reporting excellent to good outcomes on the BAROS questionnaire, and all investigated comorbidities showed clinical improvement after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QUALITY OF LIFE AFTER VERTICAL GASTRECTOMY EVALUATED BY THE BAROS QUESTIONNAIRE. Vargas, GP., Mendes, GA., Pinto, RD.[2022]

Bariatric surgery outcomes have improved significantly from 2007 to 2018, with a notable reduction in 30-day surgical complications from 6% to 2.9% and medical complications from 3.4% to 1.7% after the implementation of the MBSAQIP.

The MBSAQIP era is linked to a higher likelihood of early patient discharge (from 9.8% to 46.9%) and lower odds of complications, indicating enhanced safety and efficacy of bariatric procedures during this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program and outcomes of bariatric surgery. Al-Mazrou, AM., Bellorin, O., Dakin, G., et al.[2023]

Bariatric surgery has seen a significant reduction in perioperative mortality rates, dropping from 1.5-2% in the past to just 0.04-0.3% in recent studies involving thousands of patients, indicating improved safety over time.

Despite advancements, serious complications still occur in 1-4% of patients, particularly with malabsorptive procedures, highlighting the need for ongoing nutritional support and monitoring for issues like intestinal obstruction and anastomotic stricture post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric/metabolic surgery: short- and long-term safety. Kim, JH., Wolfe, B.[2021]

In a study of 266,544 patients undergoing laparoscopic bariatric surgery, older age was linked to a higher risk of various complications, except for venous thromboembolism and 30-day mortality.

Patients who had Roux-en-Y gastric bypass experienced worse outcomes compared to those who had sleeve gastrectomy, indicating that the type of procedure also influences perioperative risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Age Confers a Higher Risk of 30-Day Morbidity and Mortality Following Laparoscopic Bariatric Surgery: an Analysis of the Metabolic and Bariatric Surgery Quality Improvement Program. Haskins, IN., Ju, T., Whitlock, AE., et al.[2019]

Endoscopic management is a key first-line approach for addressing adverse events following bariatric surgery, such as ulcers, stenoses, and leaks, utilizing various devices like balloon dilators and stents.

This method is less invasive compared to traditional surgical interventions and often requires a multidisciplinary team, indicating its growing importance in the evolving treatment algorithms for bariatric surgery complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic devices and techniques for the management of bariatric surgical adverse events (with videos). Schulman, AR., Watson, RR., Abu Dayyeh, BK., et al.[2021]

Roux-en-Y gastric bypass (RYGB) in patients with class I obesity (BMI 30.0-34.9 kg/m²) and type 2 diabetes resulted in significant weight loss (BMI decreased from 34.6 to 25.8 kg/m²) and improved glycemic control (HbA1c decreased from 8.2% to 6.1%) after one year, while the nonsurgical control group showed no significant changes.

Patients who underwent RYGB also reduced their use of antihypertensive and antihyperlipidemia medications, although this may have contributed to persistent high blood pressure and LDL cholesterol levels, indicating a need for careful medication management post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of bariatric surgery and nonsurgical therapy in adults with type 2 diabetes mellitus and body mass index Serrot, FJ., Dorman, RB., Miller, CJ., et al.[2022]

References

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

Results of obesity surgery. [2005]

2. Brazil pubmed.ncbi.nlm.nih.gov

QUALITY OF LIFE AFTER VERTICAL GASTRECTOMY EVALUATED BY THE BAROS QUESTIONNAIRE. [2022]

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

Implementation of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program and outcomes of bariatric surgery. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Patient Perspective in Obesity Surgery: Goals for Weight Loss and Improvement of Body Shape in a Prospective Cohort Study. [2020]

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

Outcomes in Bariatric and Metabolic Surgery: an Updated 5-Year Review. [2021]

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

Interventions and Operations after Bariatric Surgery in a Health Plan Research Network Cohort from the PCORnet, the National Patient-Centered Clinical Research Network. [2021]

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

Bariatric/metabolic surgery: short- and long-term safety. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT Study. [2021]

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

Older Age Confers a Higher Risk of 30-Day Morbidity and Mortality Following Laparoscopic Bariatric Surgery: an Analysis of the Metabolic and Bariatric Surgery Quality Improvement Program. [2019]

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

Endoscopic devices and techniques for the management of bariatric surgical adverse events (with videos). [2021]

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

Comparative effectiveness of bariatric surgery and nonsurgical therapy in adults with type 2 diabetes mellitus and body mass index [2022]

12. India pubmed.ncbi.nlm.nih.gov

Bariatric to metabolic surgery: management options and experience at a tertiary centre. [2011]

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

Factors Associated with Weight Loss After Metabolic Surgery in a Multiethnic Sample of 1012 Patients. [2022]