Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Body Weight Changes
Nutrition Disorders
Obesity Morbid
Overnutrition
Overweight and Obesity

Type

Interventional

Phase

Not Applicable

Design

Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Comparative double arm studyMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age: Between 20 years and 65 years
Gender: Both males and females

Description

This is prospective cohort study. Total 400 obese patients will be enrolled(Sleeve gastrectomy 200 patients, Roux-en-Y gastric bypass 200) The principal investigator or another clinical investigator in charge will individually inform the patients about the study, before operation at out patient clinic. At that time patient is selected to either sleeve gastrectomy group or Roux-en-Y gastric bypass group. All investigator report to clinical research center about patients BMI and operation method. About 30-35 obesity patients will be enrolled according to their BMI status. Patients' BMI status is classified into several parts by 2.5 gap started from 27.5. All patients will undergo periodically anthropometry, laboratory tests, bioelectrical impedance analysis, gastrofiberscopy, polysomnography and abdomen CT before and after surgery. Patients with hypertension will undergo echocardiography. Patients with polycystic ovary syndrome will be checked hormonal study. Patients with type 2 diabetes mellitus will be performed 75g oral glucose tolerance test test. Surgical complication include wound morbidities, gastrointestinal leakage or fistula, postoperative bleeding, intra-abdominal abscess, stricture , adhesive ileus, reflux esophagitis, marginal ulceration, dumping syndrome and internal hernia. Systemic complication which is not associated with the operation field include ling morbidities, heart morbidities, urinary morbidities and others. Hospital mortality is defined as postoperative death form any cause within 30 days after operation. All patients will be followed up post operative 1 month, 3 month, 6 month, 12 month, 18 month, 24 month. All patients' liver tissue, visceral fat and subcutaneous fat will be harvested during operation. All patients' blood sample will be collected at out patient clinic visit. All patients' urine and face will be collected at out patient clinic visit and will be analyzed to evaluate microbial change throughout pre and post operation period.

Tracking Information

NCT #: NCT04554758
Collaborators: Korean Center for Disease Control and Prevention
Investigators: Principal Investigator: Yoon Seok Heo, Professor Inha University Hospital Study Director: Do Joong Park, Professor Seoul National University Hospital Study Director: Yong Suk Park, Professor Seoul National University Bundang Hospital Study Director: Seung Wan Ryu, Professor Keimyung University Hospital Study Director: Moon Won Yoo, Professor Ulsan univertisy Seoul Asan Medical Center Study Director: Han Hong Lee, Professor The Catholic University of Korea Study Director: Ji Yeon Park, Professor Kyungpook National University Hospital Study Director: Sang Hyun Kim, Professor Soonchunhyang University Hospital Study Director: Jong Won Kim, Professor Chung-Ang University Hopspital Study Director: Jong Han Kim, Professor Korea University Medical Center(Guro Hospital) Study Director: In Seob Lee, Professor Ulsan univertisy Seoul Asan Medical Center Study Director: In Gyu Kwon, Professor Yonsei University Medical Center(Gangnam Hospital) Study Director: Tae Kyung Ha, Professor Hanyang University Study Director: Sung Il Choi, Professor Kyung Hee University Hospital at Gangdong Study Director: Kyung Won Seo, Professor Kosin University Gospel Hospital