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Obesity, MorbidNCT01055054

Bariatric Surgery Registry

An observational study of Obesity, Morbid, run by Virginia Commonwealth University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Periodic analyses of our extensive database with regards to different surgical procedures for severe obesity and different obesity co-morbidities will be of benefit to our severely obese patients as well as to others world-wide. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Obesity, Morbid
How many people
8,000 participants
Where
1 siteUnited States
Study dates
1 Jul 1980to Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who have undergone bariatric surgical procedures at the Virginia Commonwealth University (VCU) Medical Center.

Who may be able to join

  • Clinical diagnosis of morbid obesity
  • Have undergone a bariatric surgical procedure at the VCU Medical Center

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • VCU Health Systems

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: Analysis Bariatric Surgery Data

Periodic analyses of our extensive database with regards to different surgical procedures for severe obesity and different obesity co-morbidities will be of benefit to our severely obese patients as well as to others world-wide.

Conditions
Obesity, Morbid
Keywords
bariatrics
Medical subject headings
Obesity, Morbid

What is being measured

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

  1. weight loss

    Measured: 1 year, 5 years

Secondary outcomes (3)

  1. surgical mortality

    Measured: 90 day post-surgery

  2. surgical morbidity

    Measured: 90 day post-surgery

  3. resolution of co-morbidities

    Measured: 1 year, 5 years

Timeline

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

  1. First posted25 Jan 2010 (estimated)
  2. Study start1 Jul 1980
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

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
Prospective
Enrolment
8,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01055054
Sponsor's protocol ID
HM1587
Status last verified
Nov 2025
First submitted
20 Jan 2010
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • Sugerman HJ, Fairman RP, Baron PL, Kwentus JA. Gastric surgery for respiratory insufficiency of obesity. Chest. 1986 Jul;90(1):81-6. doi: 10.1378/chest.90.1.81.

    PubMed 3720390

  • Sugerman HJ, Starkey JV, Birkenhauer R. A randomized prospective trial of gastric bypass versus vertical banded gastroplasty for morbid obesity and their effects on sweets versus non-sweets eaters. Ann Surg. 1987 Jun;205(6):613-24. doi: 10.1097/00000658-198706000-00002.

    PubMed 3296971

  • Sugerman HJ, Baron PL, Fairman RP, Evans CR, Vetrovec GW. Hemodynamic dysfunction in obesity hypoventilation syndrome and the effects of treatment with surgically induced weight loss. Ann Surg. 1988 May;207(5):604-13. doi: 10.1097/00000658-198805000-00015.

    PubMed 3377570

  • Sugerman HJ, Londrey GL, Kellum JM, Wolf L, Liszka T, Engle KM, Birkenhauer R, Starkey JV. Weight loss with vertical banded gastroplasty and Roux-Y gastric bypass for morbid obesity with selective versus random assignment. Am J Surg. 1989 Jan;157(1):93-102. doi: 10.1016/0002-9610(89)90427-3.

    PubMed 2910132

  • Sugerman HJ, Fairman RP, Sood RK, Engle K, Wolfe L, Kellum JM. Long-term effects of gastric surgery for treating respiratory insufficiency of obesity. Am J Clin Nutr. 1992 Feb;55(2 Suppl):597S-601S. doi: 10.1093/ajcn/55.2.597s.

    PubMed 1733136

  • Sanyal AJ, Sugerman HJ, Kellum JM, Engle KM, Wolfe L. Stomal complications of gastric bypass: incidence and outcome of therapy. Am J Gastroenterol. 1992 Sep;87(9):1165-9.

    PubMed 1519574

  • Sugerman HJ, Sugerman EL, Wolfe L, Kellum JM Jr, Schweitzer MA, DeMaria EJ. Risks and benefits of gastric bypass in morbidly obese patients with severe venous stasis disease. Ann Surg. 2001 Jul;234(1):41-6. doi: 10.1097/00000658-200107000-00007.

    PubMed 11460821

  • DeMaria EJ, Sugerman HJ, Kellum JM, Meador JG, Wolfe LG. Results of 281 consecutive total laparoscopic Roux-en-Y gastric bypasses to treat morbid obesity. Ann Surg. 2002 May;235(5):640-5; discussion 645-7. doi: 10.1097/00000658-200205000-00005.

    PubMed 11981209

  • DeMaria EJ, Schweitzer MA, Kellum JM, Meador J, Wolfe L, Sugerman HJ. Hand-assisted laparoscopic gastric bypass does not improve outcome and increases costs when compared to open gastric bypass for the surgical treatment of obesity. Surg Endosc. 2002 Oct;16(10):1452-5. doi: 10.1007/s00464-001-8321-5. Epub 2002 Jun 14.

    PubMed 12063573

  • Kothari SN, DeMaria EJ, Sugerman HJ, Kellum JM, Meador J, Wolfe L. Lap-band failures: conversion to gastric bypass and their preliminary outcomes. Surgery. 2002 Jun;131(6):625-9. doi: 10.1067/msy.2002.124879.

    PubMed 12075174

  • Sugerman HJ, Sugerman EL, DeMaria EJ, Kellum JM, Kennedy C, Mowery Y, Wolfe LG. Bariatric surgery for severely obese adolescents. J Gastrointest Surg. 2003 Jan;7(1):102-108. doi: 10.1016/S1091-255X(02)00125-7.

    PubMed 12559191

  • Sugerman HJ, Wolfe LG, Sica DA, Clore JN. Diabetes and hypertension in severe obesity and effects of gastric bypass-induced weight loss. Ann Surg. 2003 Jun;237(6):751-6; discussion 757-8. doi: 10.1097/01.SLA.0000071560.76194.11.

    PubMed 12796570

  • Fernandez AZ Jr, DeMaria EJ, Tichansky DS, Kellum JM, Wolfe LG, Meador J, Sugerman HJ. Experience with over 3,000 open and laparoscopic bariatric procedures: multivariate analysis of factors related to leak and resultant mortality. Surg Endosc. 2004 Feb;18(2):193-7. doi: 10.1007/s00464-003-8926-y. Epub 2003 Dec 29.

    PubMed 14691697

  • Fernandez AZ Jr, Demaria EJ, Tichansky DS, Kellum JM, Wolfe LG, Meador J, Sugerman HJ. Multivariate analysis of risk factors for death following gastric bypass for treatment of morbid obesity. Ann Surg. 2004 May;239(5):698-702; discussion 702-3. doi: 10.1097/01.sla.0000124295.41578.ab.

    PubMed 15082974

  • Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg. 2004 Aug;240(2):243-7. doi: 10.1097/01.sla.0000133361.68436.da.

    PubMed 15273547

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Morbid, run by Virginia Commonwealth University 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 2 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 24 Nov 2025. 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?

This study is still under way. Results are not available in the source record yet.

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 (time frame: 1 year, 5 years). 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 NCT01055054, which also lists 41 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 24 Nov 2025.

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