Lots of Questions

It's been encouraging to read everyone's posts. I've been looking into surgery for a while, but I feel ready to take the next step. I have so many questions! My insurance has gastric bypass listed as an exclusion which is frustrating. I'm not sure how I can pay for the surgery. I noticed that some of you have participated in studies, does this give you some sort of surgery discount? Thanks, Amanda

I'm not sure about other people, but the studies I'm participating in don't provide any kind of discount on the surgery.   It can be a long expensive process, particularly if you don't have insurance to cover it!  You might want to check out the Insurance Help forum.  They can give you advice about how to deal with your insurance and let you know if there might be hope for getting coverage. Good luck!! Tammy

Most of the studies aren't going to cover the cost of surgery.  Not unless it is a completely revolutionary treatment.  Many of the studies that are going on right now involve determining how much weight we're losing, how quickly, etc.  The basic stuff they'll already be tracking in the office but now be able to release our information publicly. For your information, here are the current federally sponsored clinical trials in the state of Oregon:

Longitudinal Assessment of Bariatric Surgery (LABS)

This study is currently recruiting patients. Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) February 2007

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ClinicalTrials.gov Identifier: NCT00433810

Purpose

The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.

Condition
Morbid Obesity

MedlinePlus related topics:  Obesity

Study Type: Observational Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: Longitudinal Assessment of Bariatric Surgery (LABS-1)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): Total Enrollment:  12000

Study start: March 2005;  Expected completion: February 2010

The primary objectives of this study are to assess the safety of bariatric surgery by estimating the prevalence of short term adverse outcomes in a multicenter cohort of patients undergoing bariatric surgical procedures and to determine the associations between short term adverse outcomes after bariatric surgery and both clinical/demographic patient characteristics and features of operative/perioperative care

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• All patients age 18 years or older, eligible and undergoing bariatric surgery performed by a LABS-certified surgeon.

Exclusion Criteria:

• Patients who do not provide informed consent

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00433810 Bruce Wolfe, MD      503-494-1181  United States, California       Sacramento Bariatric, Sacramento,  California,  United States; Recruiting Bruce Wolfe, MD,  Principal Investigator United States, New York       Columbia University Medical Center, New York,  New York,  10032,  United States; Recruiting Paul D Berk, MD,  Principal Investigator       Cornell University Medical Center, New York,  New York,  10021,  United States; Recruiting Paul D Berk, MD,  Principal Investigator United States, North Carolina       East Carolina University, Greenville,  North Carolina,  27834,  United States; Recruiting Walter Pories, MD, FACS,  Principal Investigator United States, North Dakota       Neuropsychiatric Research Institute, Fargo,  North Dakota,  58107,  United States; Recruiting James E Mitchell, MD,  Principal Investigator United States, Oregon       Oregon Health and Science University, Portland,  Oregon,  United States; Recruiting Bruce Wolfe, MD,  Principal Investigator       Legacy Good Samaritan Hospital, Portland,  Oregon,  United States; Recruiting Bruce Wolfe, MD,  Principal Investigator United States, Pennsylvania       University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting Anita P Courcoulas, MD, MPH, FACS,  Principal Investigator United States, Washington       University of Washington, Seattle,  Washington,  98195,  United States; Recruiting David R Flum, MD, MPH, FACS,  Principal Investigator       Virginia Mason Medical Center, Seattle,  Washington,  98195,  United States; Recruiting David R. Flum, MD, MPH, FACS,  Principal Investigator Study chairs or principal investigators Bruce Wolfe, MD,  Study Chair,  Oregon Health and Science University    David Kelley, MD,  Study Chair,  University of Pittsburgh   

More Information

Study web site

Study ID Numbers:  DK66557 Last Updated:  February 9, 2007 Record first received:  February 9, 2007 ClinicalTrials.gov Identifier:  NCT00433810 Health Authority: United States: Federal Government ClinicalTrials.gov processed this record on June 08, 2007

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Long-Term Effects of Bariatric Surgery (LABS-2)

This study is currently recruiting patients. Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) April 2007

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ClinicalTrials.gov Identifier: NCT00465829

Purpose

The primary objective of LABS-2 is to use standardized techniques and measures to assess the longer-term safety and efficacy of bariatric surgery by:

1. comparing post-surgical outcomes to pre-operative status
2. examining risks and benefits of surgery.

LABS-2 will determine the associations between clinical/demographic patient characteristics, components of the surgical procedure, and peri-operative and post-operative care with post-operative risks and changes in patient status.

Condition
Obesity

MedlinePlus related topics:  Obesity

Study Type: Observational Study Design: Natural History, Longitudinal, Convenience Sample, Prospective Study

Official Title: Longitudinal Assessment of Bariatric Surgery (LABS-2)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): Total Enrollment:  2400

Study start: March 2006;  Expected completion: August 2009

The primary goal of LABS-2 is to evaluate the efficacy and safety of bariatric surgery over a longer term than LABS-1, i.e., more than 30 days. Using a sample of the LABS-1 cohort, approximately 2,400 patients, will be recruited over 3 years. LABS-2 will include clinical assessments and detailed interviews and questionnaires pre-operatively and at several post-operative time points (30 days, 6 months, 12 months following surgery, and annually thereafter) to assess risks of surgery, and changes in clinical, metabolic, and psychosocial characteristics in patients, and health care utilization following bariatric surgery. Detailed data about the surgical procedure and peri- and post-operative care will also be collected to determine if components of the surgical procedure, and peri-operative and post-operative care as well as clinical/demographic patient characteristics are associated with post-operative risks and changes in patient status. Patients enrolled in LABS-2 will provide blood specimens pre-operatively and post-operatively to address LABS-2 hypotheses and additional samples will be stored at the NIDDK tissue repository for serologic, pathologic and genomic testing of other hypotheses.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both Criteria

Inclusion Criteria:

• Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon
• Previous enrollment in LABS-1
• Selected by algorithm to be included in LABS-2

Exclusion Criteria:

• Informed consent not obtained
• Prior bariatric surgery
• Unlikely to comply with follow-up protocol
• Unable to communicate with local study staff

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00465829 Bruce Wolfe, MD      (503) 494-1181  United States, New York       Columbia University Medical Center, New York,  New York,  10032,  United States; Recruiting Paul D Berk, MD,  Principal Investigator       Cornell University Medical Center, New York,  New York,  10021,  United States; Recruiting Paul D Berk, MD,  Principal Investigator United States, North Carolina       East Carolina University, Greenville,  North Carolina,  27834,  United States; Recruiting Walter Pories, MD, FACS,  Principal Investigator United States, North Dakota       Neuropsychiatric Research Institute, Fargo,  North Dakota,  58107,  United States; Recruiting James E Mitchell, MD,  Principal Investigator United States, Oregon       Legacy Good Samaritan Hospital, Portland,  Oregon,  United States; Recruiting Bruce Wolfe, MD,  Principal Investigator       Oregon Health and Science University, Portland,  Oregon,  United States; Recruiting Bruce Wolfe, MD,  Principal Investigator United States, Pennsylvania       University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting Anita Courcoulas, MD,MPH,FACS,  Principal Investigator United States, Washington       University of Washington, Seattle,  Washington,  98195,  United States; Recruiting David R Flum, MD,MPH,FACS,  Principal Investigator       Virginia Mason Medical Center, Seattle,  Washington,  98195,  United States; Recruiting David R. Flum, MD,MPH,FACS,  Principal Investigator Study chairs or principal investigators Paul D Berk, MD,  Principal Investigator,  Columbia University Medical Center    Anita Courcoulas, MD,MPH,FACS,  Principal Investigator,  University of Pittsburgh    David R Flum, MD,MPH,FACS,  Principal Investigator,  University of Washington    James E Mitchell, MD,  Principal Investigator,  Neuropsychiatric Research Institute    Bruce M Wolfe, MD,FACS,  Principal Investigator,  Oregon Health and Science University    Walter J Pories, MD,FACS,  Principal Investigator,  East Carolina Medical Center   

More Information

Study web site

Study ID Numbers:  DK6657_2 Last Updated:  April 24, 2007 Record first received:  April 24, 2007 ClinicalTrials.gov Identifier:  NCT00465829 Health Authority: United States: Federal Government ClinicalTrials.gov processed this record on June 08, 2007

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Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery

This study is currently recruiting patients. Verified by USGI Medical June 2007

Sponsored by: USGI Medical Information provided by: USGI Medical ClinicalTrials.gov Identifier: NCT00411489

Purpose

The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of the gastric pouch and/or stoma. A second surgical procedure to reduce the size of the pouch and/or stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure. This study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass.

Condition	Intervention
Obesity	Procedure: endolumenal surgery

MedlinePlus related topics:  Obesity

Study Type: Interventional Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Official Title: Use of a New Endosurgical Operating System for Endoscopic Stoma and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery

Further study details as provided by USGI Medical: Primary Outcome Measures: 

• weight loss

Eligibility

Ages Eligible for Study:  18 Years   -   64 Years,  Genders Eligible for Study:  Both Criteria

Inclusion Criteria:

• 18 yrs of age or older and < 65 yrs of age
• At least 2 yrs post-Roux-En-Y gastric bypass surgery
• Initially achieved at least 50% weight loss
• At enrollment, has regain at least 15% of weight loss
• BMI 40 or greater or 35 or greater with one or more co-morbidities
• Stoma diameter at least 20 mm
• Completes successful nutritional screening
• Is a candidate for a surgical revision procedure
• Is a reasonable risk to undergo general anesthesia
• Completes successful cardiopulmonary evaluation
• ASA Classification of less than or equal to III
• Able to provide written consent
• Able to return for protocol-specified evaluations

Exclusion Criteria:

• Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments
• Previous bariatric revision procedure
• Has another causal factor for weight regain other than stoma or pouch dilatation
• Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00411489 Mary Lou Mooney      949-369-3890  Ext. 1203    [email protected] United States, Massachusetts       Lahey Clinic, Burlington,  Massachusetts,  01805,  United States; Recruiting Joyce Pelletier  781-744-3706    [email protected]  Desmond Birkett, M.D.,  Principal Investigator United States, New York       Mt. Sinai School of Medicine, New York,  New York,  10029-6574,  United States; Recruiting Emily Westheimer, MSc  212-241-7438    [email protected]  Daniel M Herron, MD,  Principal Investigator       Columbia-Presbyterian Medical Center, New York,  New York,  10032,  United States; Recruiting Amna Daud, M.D., M.P.H.  212-342-0085    [email protected]  Marc Bessler, M.D.,  Principal Investigator United States, Oregon       Oregon Clinic, Portland,  Oregon,  97210,  United States; Recruiting Lisa Leeth  503-281-0561    [email protected]  Lee L Swanstrom, MD,  Principal Investigator Study chairs or principal investigators Lee L Swanstrom, MD,  Principal Investigator,  Oregon Clinic   

More Information

Study ID Numbers:  TP0165; TP0165 Last Updated:  June 5, 2007 Record first received:  December 12, 2006 ClinicalTrials.gov Identifier:  NCT00411489 Health Authority: United States: Institutional Review Board ClinicalTrials.gov processed this record on June 08, 2007

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Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk

This study is currently recruiting patients. Verified by Children's Hospital Medical Center, Cincinnati May 2007

Sponsors and Collaborators: Children's Hospital Medical Center, Cincinnati National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Pittsburgh University of Alabama at Birmingham Texas Children's Hospital University of Washington University of North Dakota East Carolina University Oregon Health and Science University Information provided by: Children's Hospital Medical Center, Cincinnati ClinicalTrials.gov Identifier: NCT00474318

Purpose

Teen-LABS is using standardized techniques to assess the short and longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.

Condition
Obesity

MedlinePlus related topics:  Obesity

Study Type: Observational Study Design: Screening, Longitudinal, Defined Population, Prospective Study

Official Title: Adolescent Bariatrics: Assessing Health Benefits and Risks

Further study details as provided by Children's Hospital Medical Center, Cincinnati: Total Enrollment:  200

Study start: March 2007;  Expected completion: July 2011

The goal of Teen-LABS is to facilitate coordinated clinical, epidemiological and behavioral research in the field of adolescent bariatric surgery, through the cooperative development of common clinical protocols and a bariatric surgery database that will collect information from participating clinical centers performing bariatric surgery on teenagers.

Teen-LABS will help pool the necessary clinical expertise and administrative resources to facilitate the conduct of multiple clinical studies in a timely, efficient manner. Also, the use of standardized definitions, shared clinical protocols and data-collection instruments will enhance investigators' ability to provide meaningful evidence-based recommendations for patient evaluation, selection and follow-up care.

In addition to investigating surgical outcomes, another broader goal of Teen-LABS is to better understand the etiology, pathophysiology, and behavioral aspects of severe obesity in youth and how this condition affects human beings over time.

Eligibility

Ages Eligible for Study:  12 Years   -   18 Years,  Genders Eligible for Study:  Both Criteria

Inclusion Criteria:

• Adolescents up to age 19
• Approved for Bariatric Surgery
• Agreement to participate in Teen-LABS Study/ understand and sign Informed Consent/Assent

Exclusion Criteria:

• Age 19 or greater
• Not Approved for Bariatric Surgery
• Unable to sign Informed Consent/Assent

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00474318 Rosie Miller, RN,CCRC      513-803-0041    [email protected] United States, Ohio       Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229,  United States; Recruiting Meg Zeller, PhD,  Sub-Investigator Thomas H Inge, MD, PhD,  Principal Investigator Study chairs or principal investigators Thomas H Inge, MD, PhD,  Study Chair,  Children's Hospital Medical Center, Cincinnati    Michael A Helmrath, MD, MS,  Principal Investigator,  Texas Childrens Hospital Medical Center    Carroll M Harmon, MD, PhD,  Principal Investigator,  Children's Hospital of Alabama    Anita P Courcoulas, MD, MPH,  Principal Investigator,  University of Pittsburgh    Judy A Bean, PhD,  Principal Investigator,  Children's Hospital Medical Center, Cincinnati    Meg Zeller, PhD,  Principal Investigator,  Children's Hospital Medical Center, Cincinnati   

More Information

Study webpage

http://www.edc.gsph.pitt.edu/LABS/public/index.html

http://www2.niddk.nih.gov/

Study webpage

Study ID Numbers:  CCHMC IRB# 07-01-13; UO-1 DK072493-01A1 Last Updated:  June 6, 2007 Record first received:  May 15, 2007 ClinicalTrials.gov Identifier:  NCT00474318 Health Authority: United States: Institutional Review Board ClinicalTrials.gov processed this record on June 08, 2007 The cheapest surgery in Oregon I'm aware of is the lap band procedure being done in Coos Bay by Dr. Steven Tersigni (http://www.baybariatrics.com/).  Lori