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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01040507
Other study ID # CMC IRB No. 2009023
Secondary ID U1111-1113-0364
Status Completed
Phase N/A
First received December 23, 2009
Last updated December 28, 2009
Start date June 2009
Est. completion date December 2009

Study information

Verified date August 2009
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The main aim of this study is to analyze and report the very long-term outcomes after primary laparoscopic proximal Roux-en-Y gastric bypass surgery for clinically severe obesity.


Description:

There is lack of very-long term outcomes after bariatric surgery; A few series have been reported. However, most of them analyze medium-term outcomes. For RYGB, there are just two retrospective cohort studies reporting very long-term outcomes. Both studies have an open approach and a proximal Roux-en-Y configuration with different pouch orientation and size. MacLean´s series, with a better follow-up rate (83.4%), had a 67.6%EWL at a mean of 11.4 years; Failure rates were 20 and 35% for the morbidly obese and super obese, respectively. We will analyze our own series with a laparoscopic approach, vertically, lesser-curve base < 10-15ml pouch and proximal Roux limb. The main end-points for our study are 1) Morbidity including status of specific biochemical markers & Mortality, 2) Weight loss expressed as BMI or %EWL, 3) Trends in major comorbidities and 4) Assessment of Quality of Life.


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- patients who met NIH criteria for recommendation of a bariatric procedure with a combination of the following characteristics

- status post primary laparoscopic proximal RYGB surgery with or without subsequent open or laparoscopic revisions or re-operations

- follow up > 10.0 years (Very long term outcome)

Exclusion Criteria:

- patients who had a previous gastric or bariatric procedure

- patients who underwent primary laparoscopic RYGB somewhere else by other surgical group

- missing records and/or unreachable patients with scant information for analysis

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States UCSF Fresno Center for Medical Education and Research, Department of Surgery Fresno California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (16)

Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. — View Citation

Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728. — View Citation

Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Ann Surg. 2006 Nov;244(5):734-40. — View Citation

Christou NV, Sampalis JS, Liberman M, Look D, Auger S, McLean AP, MacLean LD. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg. 2004 Sep;240(3):416-23; discussion 423-4. — View Citation

Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE, Buessing M. A study on the economic impact of bariatric surgery. Am J Manag Care. 2008 Sep;14(9):589-96. — View Citation

Flum DR, Khan TV, Dellinger EP. Toward the rational and equitable use of bariatric surgery. JAMA. 2007 Sep 26;298(12):1442-4. — View Citation

Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. — View Citation

Higa KD, Boone KB, Ho T, Davies OG. Laparoscopic Roux-en-Y gastric bypass for morbid obesity: technique and preliminary results of our first 400 patients. Arch Surg. 2000 Sep;135(9):1029-33; discussion 1033-4. — View Citation

McTigue KM, Harris R, Hemphill B, Lux L, Sutton S, Bunton AJ, Lohr KN. Screening and interventions for obesity in adults: summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Dec 2;139(11):933-49. — View Citation

Meguid MM, Glade MJ, Middleton FA. Weight regain after Roux-en-Y: a significant 20% complication related to PYY. Nutrition. 2008 Sep;24(9):832-42. doi: 10.1016/j.nut.2008.06.027. Review. — View Citation

Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. Epub 2007 Sep 8. — View Citation

O'Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006 Aug;16(8):1032-40. Review. — View Citation

Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. — View Citation

Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. — View Citation

Sjöström L, Narbro K, Sjöström CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lönroth H, Näslund I, Olbers T, Stenlöf K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. — View Citation

www.asbs.org/htm/Private/resolution.html. American Society of Metabolic and Bariatric Surgeons.

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Weight loss expressed as Body Mass Index and Percentage excess weight loss throughout follow-up No
Primary Comorbidity status throughout follow-up No
Primary Health-related Quality of Life (HR-QoL) at last follow-up No
Primary Subjective satisfaction at the last follow-up No
Primary Morbidity and mortality throughout follow-up Yes
Secondary Nutritional and metabolic status throughout follow-up No
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