AzTrials
AzTrials

Weight RegainWRNCT01040572

Laparoscopic Revision Gastric Bypass for Weight Recidivism

An observational study of Weight Regain and Weight Recidivism, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism. Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
132 participants
Where
1 siteUnited States
Study dates
Oct 2009to Dec 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with previously failed Roux-en-Y gastric bypass "RYGB" surgery with a weight recidivism pattern.

Who may be able to join

  • patients that underwent laparoscopic revisional "RYGB" for failed "RYGB" with weight recidivism or weight regain "WR" pattern

Who cannot join

  • failed RYGB with an Inadequate Initial Weight Loss "IIWL" pattern
  • patients with prior major bariatric conversion or esophago-gastric surgeries
  • RYGB patients revised by an open surgical approach
  • RYGB patients who underwent laparoscopic revisional RYGB surgery somewhere else and continue their follow-up care with our program
  • missing records and/or unreachable patients with scant information for analysis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Fresno Center for Medical Education and Research

    Fresno, California, 93701

Other trials in United States

About this study

Official title: Laparoscopic Revision Gastric Bypass Surgery for Weight Recidivism: Our Experience in 170 Patients

The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism.

Read the detailed description

There is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data. The treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment. Failure rates have been reported up to 20% and 35% for the morbidly obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery. The indication for further surgical intervention remains controversial, as does what type of revisional procedure, both operative and endoscopic, to recommend. Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. Therefore the approach to these patients must be as individualized as their original operations. We formally analyze our experience with all laparoscopic revisional strategies for weigh regain after failed gastric bypass.

Keywords
Obesity recidivism, Weight Regain, Weight recidivism, Morbidity, Complication, Late complications, Revisional gastric bypass, Re-operative gastric bypass, Revisional bariatric surgery, Re-operative bariatric surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01040572
Study groupRoleWhat they receive
Obesity recidivism after gastric bypassNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss expressed as Body Mass Index and Percentage Excess Weight Loss

    Measured: At the lowest weight loss point and at last follow-up

  2. Comorbidity status

    Measured: throughout follow-up

  3. Subjective Satisfaction

    Measured: at last follow-up

  4. Health-Related Quality of Life (HR-QoL).

    Measured: at the last follow-up

  5. Morbidity and mortality

    Measured: throughout follow-up

Secondary outcomes (2)

  1. To assess failures

    Measured: at yearly intervals throughout follow-up

  2. To evaluate the patients´ metabolic and nutritional status

    Measured: throughout follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01040572
Sponsor's protocol ID
CMC IRB No. 2009078
Other IDs
U1111-1113-0216
Acronym
WR
Status last verified
Oct 2009
First submitted
23 Dec 2009
Last updated
29 Dec 2009
Results posted
No
Data monitoring committee
Yes

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

  • Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath CW Jr. Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999 Oct 7;341(15):1097-105. doi: 10.1056/NEJM199910073411501.

    PubMed 10511607

  • 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 for Metabolic and Bariatric Surgery.

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Weight Regain and Weight Recidivism, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss expressed as Body Mass Index and Percentage Excess Weight Loss (time frame: At the lowest weight loss point and at last follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01040572, which also lists 59 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2009.

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