Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation
Primary Purpose
Obesity, Morbid, Overnutrition, Nutrition Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sleeve gastrectomy
Roux-en-Y gastric bypass
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring primary bariatric surgery, morbid obesity, sleeve gastrectomy, Roux-en Y gastric bypass, South Korea
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
Sites / Locations
- Inha University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sleeve gastrectomy
Roux-en-Y gastric bypass
Arm Description
200 obesity patients who undergo laparoscopic sleeve gastrectomy
200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass
Outcomes
Primary Outcome Measures
Obesity Cure Success Rate
Proportion of patients who reach BMI bellow 25
Body weight change rate
Decreased body weight proportion compare to preoperative body weight
Waist circumference change rate
Decreased waist circumference change proportion compare to preoperative waist circumference
Secondary Outcome Measures
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 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
Micronutrient deficiency
Incidence of micronutrient deficiency rate such as vitamine, calcium, iron
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)
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.
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.
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.
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)
Full Information
NCT ID
NCT04554758
First Posted
September 9, 2020
Last Updated
October 6, 2020
Sponsor
Inha University Hospital
Collaborators
Korean Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04554758
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital
Collaborators
Korean Center for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparative double arm study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleeve gastrectomy
Arm Type
Experimental
Arm Description
200 obesity patients who undergo laparoscopic sleeve gastrectomy
Arm Title
Roux-en-Y gastric bypass
Arm Type
Experimental
Arm Description
200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass
Intervention Type
Procedure
Intervention Name(s)
Sleeve gastrectomy
Intervention Description
Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass
Intervention Description
Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.
Primary Outcome Measure Information:
Title
Obesity Cure Success Rate
Description
Proportion of patients who reach BMI bellow 25
Time Frame
Postoperative 1 year
Title
Body weight change rate
Description
Decreased body weight proportion compare to preoperative body weight
Time Frame
Postoperative 1 year
Title
Waist circumference change rate
Description
Decreased waist circumference change proportion compare to preoperative waist circumference
Time Frame
Postoperative 1 year
Secondary Outcome Measure Information:
Title
Rate of morbid disease remission or partial remission
Description
Remission rate or partial remission rate of morbid disease related to obesity such as hypertension, type 2 diabetes mellitus, hyperlipidemia after surgery
Time Frame
Postoperative 1 year, 2 year
Title
Postoperative complication rate and mortality rate
Description
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
Time Frame
Within postoperative 30 days
Title
Micronutrient deficiency
Description
Incidence of micronutrient deficiency rate such as vitamine, calcium, iron
Time Frame
Postoperative 1 year, 2 year
Title
Quality of life improvement rate and degree-1
Description
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)
Time Frame
Postoperative 1 year, 2 year
Title
Quality of life improvement rate and degree-2
Description
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.
Time Frame
Postoperative 1 year, 2 year
Title
Quality of life improvement rate and degree-3
Description
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.
Time Frame
Postoperative 1 year, 2 year
Title
Quality of life improvement rate and degree-4
Description
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.
Time Frame
Postoperative 1 year, 2 year
Title
Quality of life improvement rate and degree-5
Description
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)
Time Frame
Postoperative 1 year, 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoon Seok Heo, Professor
Phone
+82-32-890-3437
Email
gsheo@inha.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Suk Choi, Instructor
Phone
+82-32-890-3437
Email
yunsukki@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon Seok Heo, Professor
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Do Joong Park, Professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yong Suk Park, Professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seung Wan Ryu, Professor
Organizational Affiliation
Keimyung University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Moon Won Yoo, Professor
Organizational Affiliation
Ulsan univertisy Seoul Asan Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Han Hong Lee, Professor
Organizational Affiliation
The Catholic University of Korea
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ji Yeon Park, Professor
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sang Hyun Kim, Professor
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jong Won Kim, Professor
Organizational Affiliation
Chung-Ang University Hopspital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jong Han Kim, Professor
Organizational Affiliation
Korea University Medical Center(Guro Hospital)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
In Seob Lee, Professor
Organizational Affiliation
Ulsan univertisy Seoul Asan Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
In Gyu Kwon, Professor
Organizational Affiliation
Yonsei University Medical Center(Gangnam Hospital)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tae Kyung Ha, Professor
Organizational Affiliation
Hanyang University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sung Il Choi, Professor
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kyung Won Seo, Professor
Organizational Affiliation
Kosin University Gospel Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon Seok Heo, Professor
Phone
+82-32-890-3435
Email
gsheo@inha.ac.kr
12. IPD Sharing Statement
Learn more about this trial
Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation
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