Homocysteine After Laparoscopic Roux-enY Gastric Bypass

Medical University of Vienna

Status: Completed

Conditions: Vitamin B 12 Deficiency; Bariatric Surgery Candidate; Homocystine; Metabolic Disorder; Folate Deficiency; Obesity, Morbid

Treatments: Procedure: laparoscopic long limb roux-en-Y gastric bypass

Study type: Observational

Funder types: Other

Identifiers

NCT03489538

EK1143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 708 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI > 40kg/m2 or BMI > 35 kg/m2 including relevant comorbidities
• Age between 18 to 75 years
• suitable for operation, consent
• no contraindications for the operation

Exclusion criteria

• BMI < 35 kg/m2
• age below 18 or above 75 years
• not able to consent to the operation
• severe medical conditions not applicable for general anaesthesia
• non compliance

Trial design

708 participants in 1 patient group

RYGB Patients

Description:

Laparoscopic long limb roux-en-Y gastric bypass group. All consecutive patients eligible for bariatric surgery.

Treatment:

Procedure: laparoscopic long limb roux-en-Y gastric bypass