Weight Loss Surgery Outcomes for Obesity
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
678910How 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.
15111213Eligibility 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
+2 more
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Patients with BMI between 30-34.5 kg/m2Experimental Treatment1 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 United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Bariatric Surgery for:
- Obesity with BMI ≥ 40 kg/m²
- Obesity with BMI ≥ 35 kg/m² and at least one obesity-related comorbidity
🇪🇺 Approved in European Union as Bariatric Surgery for:
- Obesity with BMI ≥ 40 kg/m²
- Obesity with BMI ≥ 35 kg/m² and at least one obesity-related comorbidity
🇨🇦 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
🇦🇺 Approved in Australia as Bariatric Surgery for:
- Obesity with BMI ≥ 40 kg/m²
- Obesity with BMI ≥ 35 kg/m² and at least one obesity-related comorbidity
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dr. Feiz and AssociatesBeverly Hills, CA
Loading ...
Who Is Running the Clinical Trial?
Dr. Feiz & AssociatesLead Sponsor
References
Results of obesity surgery. [2005]Assessment of the outcome of obesity operations is exceedingly complex. Currently there is no consensus among bariatric surgeons as to what constitutes successful weight loss. Furthermore, weight loss data must be regularly reevaluated to account for later regaining of lost weight. There is no question that surgically-induced weight loss results in improvement or resolution of obesity-related medical problems in most patients. Yet it is not known whether sustained long-term weight loss will result in extended amelioration of these medical problems. Analysis of outcome is further complicated by difficulties in maintaining consistent long-term follow-up in such a way that the benefits of weight loss can be objectively evaluated. The next decade should provide improvements in a number of these problem areas. The new computer registry of the American Society of Bariatric Surgery has access to thousands of bariatric surgical patients. This registry will hopefully provide for some standardization in analysis and reporting of results of bariatric operations. The registry may eventually be able to provide the type of actuarial analysis of long-term results necessary to assess the true impact of bariatric operations on the morbidity and mortality risks associated with morbid obesity. It is also probable that more sophisticated patient selection methods will improve the likelihood of successful weight loss both by excluding patients who are prone to failure and by identification of patient profiles that are better suited for treatment by one type of operation over another. In the final analysis, there is no question that morbid obesity poses an increased risk to health and longevity. Thus it is only logical that substantial weight loss in this group of patients could be expected to improve both longevity and quality of life, provided that the treatment methods employed are free of serious side-effects. At present, surgery offers the only realistic hope for successful weight loss in the morbidly obese.
QUALITY OF LIFE AFTER VERTICAL GASTRECTOMY EVALUATED BY THE BAROS QUESTIONNAIRE. [2022]The satisfactory outcome in the surgical treatment of obesity must include, in addition to weight loss, a significant change in the pre-existing comorbidities and in the quality of life of the patients.
Implementation of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program and outcomes of bariatric surgery. [2023]This study evaluates the performance of bariatric surgery prior to and after the implementation of Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP).
Patient Perspective in Obesity Surgery: Goals for Weight Loss and Improvement of Body Shape in a Prospective Cohort Study. [2020]Obesity surgery provides sustainable weight loss, improvement of comorbidities, and improved quality of life (QOL). There is few evidence on the patient perspective and goals. This study compared expected and achieved weight loss, body shape, and QOL.
Outcomes in Bariatric and Metabolic Surgery: an Updated 5-Year Review. [2021]Knowledge regarding postoperative outcomes after bariatric and metabolic surgery continues to evolve. This review highlights key findings in outcomes research over the last 5 years related to weight loss, remission of obesity-related disease, reflux, revisional surgery, robotic-assisted surgical platforms, and adolescent populations.
Interventions and Operations after Bariatric Surgery in a Health Plan Research Network Cohort from the PCORnet, the National Patient-Centered Clinical Research Network. [2021]Obesity is a highly prevalent condition with severe clinical burden. Bariatric procedures are an important and expanding treatment option. This study compared short-(30-day composite adverse events) and long-term (intervention/operation, endoscopy, hospitalization, and mortality up to 5 years) safety outcomes associated with three bariatric surgical procedures.
Bariatric/metabolic surgery: short- and long-term safety. [2021]The increasing incidence of bariatric/metabolic surgery has brought concerns about the short- and long-term safety of this definitive treatment option. Many multicenter, large cohort studies of outcomes after bariatric surgery have been performed worldwide. Due to innovation in surgical methods and postoperative management programs in this field, there is a continuous improvement of outcomes related to safety. Many systemic and surgical complications after bariatric surgery have been reported, and late complications after gastric banding procedure are becoming issues as long-term follow-up studies are being performed. These databases utilize both clinical and administrative data methods. They may report in hospital only 30 or 90 day complication rates. Perioperative mortality in the past has been reported in as many as 1.5 to 2 % of bariatric surgical cases. Most recently this mortality has been reduced to 0.04-0.3 % from registries involving many thousands of patients. Complications are defined variably. Serious complications reportedly occur in 1-4 % of patients. In malabsorptive procedures, nutritional and micronutrient support is important because they frequently cause nutritional and metabolic problems long after surgery. Also, procedure-related complications such as intestinal obstruction and anastomotic stricture should be monitored after gastric bypass. This review refers to such adverse events which can threaten patient safety after bariatric surgery.
Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT Study. [2021]Outcome reporting in bariatric surgery needs a core outcome set (COS), an agreed minimum set of outcomes reported in all studies of a particular condition. The aim of this study was to summarize outcome reporting in bariatric surgery to inform the development of a COS. Outcomes reported in randomized controlled trials (RCTs) and large non-randomized studies identified by a systematic review were listed verbatim and categorized into domains, scrutinizing the frequency of outcome reporting and uniformity of definitions. Ninety studies (39 RCTs) identified 1,088 separate outcomes, grouped into nine domains with most (n = 920, 85%) reported only once. The largest outcome domain was 'surgical complications', and overall, 42% of outcomes corresponded to a theme of 'adverse events'. Only a quarter of outcomes were defined, and where provided definitions, which were often contradictory. Percentage of excess weight loss was the main study outcome in 49 studies, but nearly 40% of weight loss outcomes were heterogeneous, thus not comparable. Outcomes of diverse bariatric operations focus largely on adverse events. Reporting is inconsistent and ill-defined, limiting interpretation and comparison of published studies. Thus, we propose and are developing a COS for the surgical treatment of severe and complex obesity.
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]There is a paucity of literature describing the association of age with the risk of adverse events following bariatric surgery. The purpose of this study is to investigate the association of age with 30-day morbidity and mortality following laparoscopic bariatric surgery using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database.
Endoscopic devices and techniques for the management of bariatric surgical adverse events (with videos). [2021]As the prevalence of obesity continues to rise, increasing numbers of patients undergo bariatric surgery. Management of adverse events of bariatric surgery may be challenging and often requires a multidisciplinary approach. Endoscopic intervention is often the first line of therapy for management of these adverse events. This document reviews technologies and techniques used for endoscopic management of adverse events of bariatric surgery, organized by surgery type.
Comparative effectiveness of bariatric surgery and nonsurgical therapy in adults with type 2 diabetes mellitus and body mass index [2022]Outcomes of bariatric surgery in patients with a body mass index (BMI)
Bariatric to metabolic surgery: management options and experience at a tertiary centre. [2011]Obesity proves to be a growing pandemic with severe health and economic implications. Bariatric surgeries are now recognised as metabolic surgeries given the excellent resolution of metabolic derangements accompanying obesity. This concept of metabolic surgery is now applied to non-obese population with metabolic disorders. The type II diabetes mellitus remission rates as high as 95% have been reported, least with restrictive procedures and maximum with malabsorptive procedures and such effect occurs even before substantial weight loss. This has led to increased understanding of diabetes pathophysiology and formulation of foregut and hindgut hypothesis. The aim of this study was to briefly review the management options for morbid obesity and present the results at a high volume centre. Data from 518 patients who underwent laparoscopic bariatric surgeries at this institute since 2002 were taken up for analysis retrospectively. Study population included 518 patients with 310 males and 208 females. Excess body weight loss and comorbidity resolution rates were analysed. Laparoscopic bariatric surgery is safe and effective for excess body weight loss and confers excellent resolution of associated comorbidities.
Factors Associated with Weight Loss After Metabolic Surgery in a Multiethnic Sample of 1012 Patients. [2022]Metabolic surgery is the most effective method for weight loss in the long-term treatment of morbid obesity and its comorbidities. The primary aim of this study was to examine factors associated with percent total weight loss (%TWL) after metabolic surgery among an ethnically diverse sample of patients.