Trials / Completed
CompletedNCT03489538
Homocysteine After Laparoscopic Roux-enY Gastric Bypass
Homocysteine After Laparoscopic Roux-enY Gastric Bypass: a Comprehensive Evalutation in 708 Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 708 (actual)
- Sponsor
- Medical University of Vienna · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Changes in homocysteine values after bariatric surgery remain controversially discussed. This is the first comprehensive summary to depict timeline changes in homocysteine levels following laparoscopic roux-en-Y gastric bypass.
Detailed description
Homocysteine is an independent risk factor for cardiovascular disease. Changes in homocysteine levels following bariatric surgery remain controversially discussed. 708 consecutive patients underwent laparoscopic roux-en-Y gastric bypass over a 6 year period. Throughout their routine follow-up, demographic data as well as homocysteine, folate and vitamin B12 were retrospectively collected at the timepoints: preoperatively, at 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, and 96 months postoperatively. In order to reveal clinical relevance of the results, patients were sent a special questionnaire accompanied by an informed consent form for participation and asked for cardiovascular disease events (myocardial infarction, stroke, deep venous thrombosis) or any other hospital stay after the surgery and cross checked with two region wide databases which account for approx. 80% of all hospital contacts in the region. Additionally, the database was networked with the statewide death registry in order to reveal deceased subjects and data about their demise through the beforementioned databases was collected.
Conditions
- Obesity, Morbid
- Homocystine; Metabolic Disorder
- Bariatric Surgery Candidate
- Folate Deficiency
- Vitamin B 12 Deficiency
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | laparoscopic long limb roux-en-Y gastric bypass | standard laparoscopic roux-en-Y gastric bypass (biliopancreatic limb 40 to 60 cm, alimentary limb 150 cm) |
Timeline
- Start date
- 2013-04-09
- Primary completion
- 2017-09-11
- Completion
- 2017-09-11
- First posted
- 2018-04-05
- Last updated
- 2018-04-05
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT03489538. Inclusion in this directory is not an endorsement.