Korean OBEsity Surgical Treatment Study (KOBESS)

Seoul National University

Status: Unknown

Conditions: Bariatric Surgery Candidate; Obesity, Morbid

Treatments: Other: Sleeve gastrectomy or Roux-en-Y gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT03100292

B-1608/357-005

Details and patient eligibility

About

This trial is a multi-center, single-arm, prospective, observational cohort study of patients undergoing primary bariatric surgical procedures in Korea. A total of 100 patients will be recruited over a 1-year period from 2016 to 2017, and will be followed for a mean follow-up period of 1 year after surgery. The eligible subjects who have given their consent to participate will undergo one of two surgical procedures; sleeve gastrectomy and Roux-en Y gastric bypass.

The primary objective of this clinical trial is to measure the changes in body weight (kg) and waist circumference (cm) of the enrolled patients at postoperative 1 year. Secondary outcomes are improvement or remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea), and the change in quality of life. Additionally, postoperative incidences of morbidity and mortality, micronutrient status, body composition, and cost-effectiveness of surgical intervention will be examined.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. body mass index (BMI) ≥ 35 kg/m2 or BMI ≥ 30 kg/m2 with co-morbidities such as hypertension, glucose intolerance, dyslipidemia, and sleep apnea
2. being suitable for general anesthesia
3. being able to give informed consent and committed to follow-up
4. Female patients should have a negative urine pregnancy test at screening and agree to use reliable method of contraception for 1 year.

Exclusion criteria

1. prior bariatric surgery of any kind
2. being unable to understand the risks, benefits and compliance requirements of this trial
3. pregnancy or planning on being pregnancy
4. non-Korean speaker
5. American society of anesthesiology (ASA) class IV or higher
6. malignancy within 5 years.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

bariatric surgery

Experimental group

Description:

This trial is a single-arm study and the enrolled patients are going to undergo sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB). If the patient has Barrett's esophagus on the preoperative endoscopy, SG is not permitted. Inflammatory bowel disease and Helicobacter pylori infection on a rapid urease test are contraindications of RYGB.

Treatment:

Other: Sleeve gastrectomy or Roux-en-Y gastric bypass