Clinical trial NCT04554758: Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation
Official title: Korean OBEsity Surgical Treatment Study(KOBESS-II) : Protocol of a Prospective Multicenter Cohort Study on Morbid Obesity Patients Undergoing Sleeve Gastrectomy Versus Roux-en Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight and Obesity
Body Weight Changes
Keywords: primary bariatric surgery
morbid obesity
sleeve gastrectomy
Roux-en Y gastric bypass
South Korea
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
Collaborators: name: Korean Center for Disease Control and Prevention
First posted: 2020-09-18
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative double arm study
Primary purpose: TREATMENT

Brief summary: Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* obesity patients(BMI over 35)
* morbid obesity patients(BMI over 30) with cardiovascular disease, hypertension, hyperlipidemia, type 2 diabetes mellitus, obstructive sleep apnea
* type 2 diabetes mellitus obesity patients(BMI over 27.5) who were treated medical therapy or HbA1C level over 7%

Exclusion Criteria:

* Patients who underwent previously bariatric operation
* Patients who were diagnosed malignant disease patients within 5 years
* Patients who were involved with other clinical trial within 3 months
* Patients who are risky to conduct general anesthesia for operation

Primary outcomes:
measure: Obesity Cure Success Rate
timeFrame: Postoperative 1 year
measure: Body weight change rate
timeFrame: Postoperative 1 year
measure: Waist circumference change rate
timeFrame: Postoperative 1 year
Secondary outcomes:
measure: Rate of morbid disease remission or partial remission
timeFrame: Postoperative 1 year, 2 year
measure: Postoperative complication rate and mortality rate
timeFrame: Within postoperative 30 days
measure: Micronutrient deficiency
timeFrame: Postoperative 1 year, 2 year
measure: Quality of life improvement rate and degree-1
timeFrame: Postoperative 1 year, 2 year
measure: Quality of life improvement rate and degree-2
timeFrame: Postoperative 1 year, 2 year
measure: Quality of life improvement rate and degree-3
timeFrame: Postoperative 1 year, 2 year
measure: Quality of life improvement rate and degree-4
timeFrame: Postoperative 1 year, 2 year
measure: Quality of life improvement rate and degree-5
timeFrame: Postoperative 1 year, 2 year
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inha University Hospital
name: Yoon Seok Heo, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Do Joong Park, Professor
role: STUDY_DIRECTOR
affiliation: Seoul National University Bundang Hospital
name: Yong Suk Park, Professor
role: STUDY_DIRECTOR
affiliation: Keimyung University Hospital
name: Seung Wan Ryu, Professor
role: STUDY_DIRECTOR
affiliation: Ulsan univertisy Seoul Asan Medical Center
name: Moon Won Yoo, Professor
role: STUDY_DIRECTOR
affiliation: The Catholic University of Korea
name: Han Hong Lee, Professor
role: STUDY_DIRECTOR
affiliation: Kyungpook National University Hospital
name: Ji Yeon Park, Professor
role: STUDY_DIRECTOR
affiliation: Soonchunhyang University Hospital
name: Sang Hyun Kim, Professor
role: STUDY_DIRECTOR
affiliation: Chung-Ang University Hopspital
name: Jong Won Kim, Professor
role: STUDY_DIRECTOR
affiliation: Korea University Medical Center(Guro Hospital)
name: Jong Han Kim, Professor
role: STUDY_DIRECTOR
affiliation: Ulsan univertisy Seoul Asan Medical Center
name: In Seob Lee, Professor
role: STUDY_DIRECTOR
affiliation: Yonsei University Medical Center(Gangnam Hospital)
name: In Gyu Kwon, Professor
role: STUDY_DIRECTOR
affiliation: Hanyang University
name: Tae Kyung Ha, Professor
role: STUDY_DIRECTOR
affiliation: Kyung Hee University Hospital at Gangdong
name: Sung Il Choi, Professor
role: STUDY_DIRECTOR
affiliation: Kosin University Gospel Hospital
name: Kyung Won Seo, Professor
role: STUDY_DIRECTOR
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