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Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass

NCT ID: NCT01040507

Last Updated: 2009-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Clinically Severe Obesity

Keywords

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severe obesity morbid obesity gastric bypass efficacy of gastric bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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primary laparoscopic gastric bypass

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program

Principal Investigators

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Francisco M Tercero, MD

Role: STUDY_DIRECTOR

Research Associate, University of California San Francisco

Kelvin D Higa, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Surgery, University of California San Francisco

Locations

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UCSF Fresno Center for Medical Education and Research, Department of Surgery

Fresno, California, United States

Site Status

Countries

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United States

References

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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. doi: 10.1001/archsurg.135.9.1029.

Reference Type BACKGROUND
PMID: 10982506 (View on PubMed)

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. doi: 10.1001/jama.291.23.2847.

Reference Type BACKGROUND
PMID: 15199035 (View on PubMed)

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. doi: 10.7326/0003-4819-139-11-200312020-00013.

Reference Type BACKGROUND
PMID: 14644897 (View on PubMed)

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. doi: 10.1001/jama.292.14.1724.

Reference Type BACKGROUND
PMID: 15479938 (View on PubMed)

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. doi: 10.1097/01.sla.0000137343.63376.19.

Reference Type BACKGROUND
PMID: 15319713 (View on PubMed)

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. doi: 10.1056/NEJMoa066603.

Reference Type BACKGROUND
PMID: 17715409 (View on PubMed)

Sjostrom L, Narbro K, Sjostrom 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, Lonroth H, Naslund I, Olbers T, Stenlof 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. doi: 10.1056/NEJMoa066254.

Reference Type BACKGROUND
PMID: 17715408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18778174 (View on PubMed)

Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. doi: 10.1001/jama.294.15.1909.

Reference Type BACKGROUND
PMID: 16234497 (View on PubMed)

Flum DR, Khan TV, Dellinger EP. Toward the rational and equitable use of bariatric surgery. JAMA. 2007 Sep 26;298(12):1442-4. doi: 10.1001/jama.298.12.1442. No abstract available.

Reference Type BACKGROUND
PMID: 17895461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18725080 (View on PubMed)

Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. doi: 10.1007/s00464-007-9572-6. Epub 2007 Sep 8. No abstract available.

Reference Type BACKGROUND
PMID: 17828427 (View on PubMed)

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

Reference Type BACKGROUND

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. doi: 10.1381/096089206778026316.

Reference Type BACKGROUND
PMID: 16901357 (View on PubMed)

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. doi: 10.1097/00000658-199509000-00011.

Reference Type BACKGROUND
PMID: 7677463 (View on PubMed)

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. doi: 10.1097/01.sla.0000217592.04061.d5.

Reference Type BACKGROUND
PMID: 17060766 (View on PubMed)

Related Links

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http://www.fresno.ucsf.edu/surgery

"Click here for more information about the department sponsor´s web site"

Other Identifiers

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U1111-1113-0364

Identifier Type: OTHER

Identifier Source: secondary_id

CMC IRB No. 2009023

Identifier Type: -

Identifier Source: org_study_id