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

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

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

Study Overview

• Status: Recruiting
• Conditions: Overnutrition; Nutrition Disorders; Body Weight Changes; Obesity, Morbid; Overweight and Obesity
• Intervention / Treatment: Procedure: Sleeve gastrectomy; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yoon Seok Heo, Professor; Phone Number: +82-32-890-3437; Email: gsheo@inha.ac.kr
• Study Contact Backup: Name: Yun Suk Choi, Instructor; Phone Number: +82-32-890-3437; Email: yunsukki@gmail.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Recruiting
    • Inha University Hospital
    • Contact: Yoon Seok Heo, Professor; Phone Number: +82-32-890-3435; Email: gsheo@inha.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sleeve gastrectomy; 200 obesity patients who undergo laparoscopic sleeve gastrectomy	Procedure: Sleeve gastrectomy; Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
EXPERIMENTAL: Roux-en-Y gastric bypass; 200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass	Procedure: Roux-en-Y gastric bypass; Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obesity Cure Success Rate	Proportion of patients who reach BMI bellow 25	Postoperative 1 year
Body weight change rate	Decreased body weight proportion compare to preoperative body weight	Postoperative 1 year
Waist circumference change rate	Decreased waist circumference change proportion compare to preoperative waist circumference	Postoperative 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of morbid disease remission or partial remission	Remission rate or partial remission rate of morbid disease related to obesity such as hypertension, type 2 diabetes mellitus, hyperlipidemia after surgery	Postoperative 1 year, 2 year
Postoperative complication rate and mortality rate	Number of participants surgical complications associate with the surgical technique or the operation field Number of participants mortality after operation associated with surgical complication or underlying disease	Within postoperative 30 days
Micronutrient deficiency	Incidence of micronutrient deficiency rate such as vitamine, calcium, iron	Postoperative 1 year, 2 year
Quality of life improvement rate and degree-1	Patients rate and quantitative analysis of the improved life quality using several survey EQ-5D-3L(EuroQol-5D) consists of 5 dimensions(mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each of which is scored as no/some/extreme problems. The dimension scores are converted into health utility scores ranging form 0(death) to 1(perfect health)	Postoperative 1 year, 2 year
Quality of life improvement rate and degree-2	EQ-VAS(EuroQol-Visual Analogue scale) is a question scale ranging form 0 to 100. 0 indicated the worst and 100 indicated the best condition. EQ-VAS provides important, complementary information on patient's view about their own health.	Postoperative 1 year, 2 year
Quality of life improvement rate and degree-3	Impact of Weight on QoL(IWQoL) has 5 dimensions and each dimension has several items.; physical function : 11 items; self-esteem : 7 items; sexual life : 4 items; public distress : 5 items; work : 4 items Score range from 0 to 100 and 100 represents the best quality of life.	Postoperative 1 year, 2 year
Quality of life improvement rate and degree-4	Moore-head-Ardelt QoL questionnaire II(MA-II) has 6 items(general self-esteem, physical activity, social contacts, satisfaction concerning work, pleasure related to sexuality and focus on eating behavior). All items are scored according to 10-level Likert scale(-0.5 to 0.5) and all have the same weight.	Postoperative 1 year, 2 year
Quality of life improvement rate and degree-5	Obesity-related Psychosocial Problem scale(OP scale) consists of 8 items that measure the bothersome impact of body weight on given situations. (private gatherings in their own home, private gatherings at their friend or relative's home and going to restaurant)	Postoperative 1 year, 2 year

Collaborators and Investigators

• Sponsor: Inha University Hospital
• 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 13, 2020
• First Posted (ACTUAL): September 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: morbid obesity; sleeve gastrectomy; Roux-en Y gastric bypass; primary bariatric surgery; South Korea
• Additional Relevant MeSH Terms: Obesity; Overweight; Body Weight; Obesity, Morbid; Body Weight Changes; Nutrition Disorders; Overnutrition
• Other Study ID Numbers: KOBESS-II trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No