ClinicalTrials.gg
CompletedNCT01040507>10yrsRYGBUpdated Dec 29, 2009

Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass

An observational study in Clinically Severe Obesity, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-12-29.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
242
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Clinically Severe Obesity

Browse trials for

Keywords

  • severe obesity
  • morbid obesity
  • gastric bypass
  • efficacy of gastric bypass
03

In context

Obesity, Morbid

936 studies on the registry are indexed under Obesity, Morbid; 169 are open to participants now.

This study's enrollment of 242 is above the median of 77 across 311 observational studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who had clinically severe obesity and underwent a primary laparoscopic Roux-en-Y Gastric Bypass more than years ago were identified form a prospectively maintained database at UCSF Fresno / ALSA med group, Inc Minimally Invasive Surgery Program.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
242 participants (actual)

Groups and cohorts

  • primary laparoscopic gastric bypass
06

What researchers measure

Primary outcomes

  1. Weight loss expressed as Body Mass Index and Percentage excess weight loss

    Time frame: throughout follow-up

  2. Comorbidity status

    Time frame: throughout follow-up

  3. Health-related Quality of Life (HR-QoL)

    Time frame: at last follow-up

  4. Subjective satisfaction

    Time frame: at the last follow-up

  5. Morbidity and mortality

    Time frame: throughout follow-up

Secondary outcomes

  1. Nutritional and metabolic status

    Time frame: throughout follow-up

07

Study locations

1 site
  • UCSF Fresno Center for Medical Education and Research, Department of Surgery
    Fresno, California 93701, United States
08

References and documents

Publications

  • 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. PubMed 10982506 ↗
  • 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. PubMed 15199035 ↗
  • 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. PubMed 14644897 ↗
  • 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. PubMed 15479938 ↗
  • 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. PubMed 15319713 ↗
  • 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. PubMed 17715409 ↗
  • 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. PubMed 17715408 ↗
  • 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. PubMed 18778174 ↗
  • 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. PubMed 16234497 ↗
  • 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. PubMed 17895461 ↗
  • 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. PubMed 18725080 ↗
  • 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. PubMed 17828427 ↗
  • www.asbs.org/htm/Private/resolution.html. American Society of Metabolic and Bariatric Surgeons.
  • 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. PubMed 16901357 ↗
  • 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. PubMed 7677463 ↗
  • 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. PubMed 17060766 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01040507
First posted
Dec 29, 2009
Start date
Jun 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Dec 29, 2009

Study contacts

Francisco M Tercero, MD
study director · Research Associate, University of California San Francisco
Kelvin D Higa, MD
principal investigator · Professor of Surgery, University of California San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion