Inadequate Initial Weight LossIIWLNCT01040377

Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss

An observational study of Inadequate Initial Weight Loss and Persistent Clinically Severe Obesity, 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 inadequate initial weight loss. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Inadequate Initial Weight Loss, Persistent Clinically Severe Obesity
How many people: 42 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 that underwent laparoscopic revision gastric bypass after previously failed Roux-en-Y gastric bypass "RYGB" with an Inadequate initial weight loss "IIWL" pattern.

Who may be able to join

laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern

Who cannot join

failed RYGB with a WR 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 program
missing records and/or unreachable patients with scan 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 for Inadequate Initial Weight Loss After Gastric Bypass: Intermediate Results

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 Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).

Conditions: Inadequate Initial Weight Loss, Persistent Clinically Severe Obesity
Keywords: Inadequate Initial Weight Loss, Inadequate weight loss, Poor weight loss, Failed gastric bypass, Revision gastric bypass

What participants receive

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

Study groups in NCT01040377
Study group	Role	What they receive
Inadequate initial weight loss after gastric bypass		Not described

What is being measured

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

Weight loss expressed as Body Mass Index and Percentage excess weight loss
Measured: at the lowest weight loss point and at last follow-up
Comorbidity status
Measured: throughout follow-up
Health-related Quality of Life (HR-QoL)
Measured: at last follow-up
Subjective satisfaction
Measured: at the last follow-up
Morbidity and mortality
Measured: throughout follow-up

Secondary outcomes (2)

Failure/success rate
Measured: at yearly intervals throughout follow-up
Metabolic and nutritional variables
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.

Oct 2009Dec 2009

First posted29 Dec 2009 (estimated)
Study startOct 2009
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (59)Papers the sponsor has linked to this study.
Other trials for Inadequate Initial Weight LossStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01040377
Sponsor's protocol ID: CMC IRB No. 2009077
Other IDs: U1111-1113-0264
Acronym: IIWL
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 of 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

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss After Gastric Bypass: Intermediate Results
ClinicalTrials.gov ID: NCT01040377
Acronym / sponsor ID: IIWL / CMC IRB No. 2009077
Conditions: Inadequate Initial Weight Loss, Persistent Clinically Severe Obesity
Keywords: Inadequate Initial Weight Loss, Inadequate weight loss, Poor weight loss, Failed gastric bypass, Revision gastric bypass
Study type: Observational
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: Oct 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 29 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Inadequate initial weight loss after gastric bypass	–	–

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients that underwent laparoscopic revision gastric bypass after previously failed Roux-en-Y gastric bypass "RYGB" with an Inadequate initial weight loss "IIWL" pattern.

Key inclusion criteria (1 listed)

laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern

Key exclusion criteria (5 listed)

failed RYGB with a WR 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 program
missing records and/or unreachable patients with scan information for analysis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
Comorbidity status
Time frame: throughout follow-up
Health-related Quality of Life (HR-QoL)
Time frame: at last follow-up
Subjective satisfaction
Time frame: at the last follow-up
Morbidity and mortality
Time frame: throughout follow-up

2 secondary outcomes

Failure/success rate
Time frame: at yearly intervals throughout follow-up
Metabolic and nutritional variables
Time frame: throughout follow-up

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2009.
Background: PubMed 10982506Higa 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.
Background: PubMed 15199035Hedley 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.
Background: PubMed 10511607Calle 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.
Background: PubMed 14644897McTigue 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.
Background: PubMed 15479938Buchwald 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.
Background: PubMed 15319713Christou 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.
Background: PubMed 17715409Adams 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.
Background: PubMed 17715408Sjostrom 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.
Background: PubMed 18778174Cremieux 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.
Background: PubMed 16234497Santry 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.
Background: PubMed 17895461Flum 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.
Background: PubMed 18725080Meguid 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.
"Click here for more information about the department sponsor´s web site"Link provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francisco M Tercero, MD study director

Research Associate, University of California San Franisco

Kelvin D Higa, MD principal investigator

Professor of Surgery, University of California San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Inadequate Initial Weight Loss and Persistent Clinically Severe Obesity, 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 NCT01040377, 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.