Obesity, MorbidNCT04554758
Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation
A study testing Sleeve gastrectomy and Roux-en-Y gastric bypass in people with Obesity, Morbid and Overnutrition, run by Inha University Hospital at 1 site in South Korea.
Trial summary
Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Morbid, Overnutrition, Nutrition Disorders
- What is being tested?
- Sleeve gastrectomy and Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2020to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inha University Hospital
Incheon
Yoon Seok Heo, Professor, +82-32-890-3435, gsheo@inha.ac.kr
About this study
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
Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass
Read the 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.
- Conditions
- Obesity, Morbid, Overnutrition, Nutrition Disorders, Overweight and Obesity, Body Weight Changes
- Being tested
- Sleeve gastrectomy, Roux-en-Y gastric bypass
- Keywords
- primary bariatric surgery, morbid obesity, sleeve gastrectomy, Roux-en Y gastric bypass, South Korea
- Medical subject headings
- Obesity, Morbid, Overnutrition, Nutrition Disorders, Overweight, Obesity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
Roux-en-Y gastric bypassProcedure or surgery
Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy | Experimental | 200 obesity patients who undergo laparoscopic sleeve gastrectomy Receives: Procedure: Sleeve gastrectomy |
| Roux-en-Y gastric bypass | Experimental | 200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass Receives: Procedure: Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity Cure Success Rate
Proportion of patients who reach BMI bellow 25
Measured: Postoperative 1 year
Body weight change rate
Decreased body weight proportion compare to preoperative body weight
Measured: Postoperative 1 year
Waist circumference change rate
Decreased waist circumference change proportion compare to preoperative waist circumference
Measured: Postoperative 1 year
Secondary outcomes (8)
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
Measured: 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
Measured: Within postoperative 30 days
Micronutrient deficiency
Incidence of micronutrient deficiency rate such as vitamine, calcium, iron
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Postoperative 1 year, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Sep 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparative double arm study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Yoonseok Heo, Inha University Hospital
- Investigators
- Yoon Seok Heo, Professor, Principal investigator, Inha University HospitalDo Joong Park, Professor, Study director, Seoul National University HospitalYong Suk Park, Professor, Study director, Seoul National University Bundang HospitalSeung Wan Ryu, Professor, Study director, Keimyung University HospitalMoon Won Yoo, Professor, Study director, Ulsan univertisy Seoul Asan Medical CenterHan Hong Lee, Professor, Study director, The Catholic University of KoreaJi Yeon Park, Professor, Study director, Kyungpook National University HospitalSang Hyun Kim, Professor, Study director, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554758
- Sponsor's protocol ID
- KOBESS-II trial
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04554758
- Acronym / sponsor ID
- KOBESS-II trial
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative double arm study
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy | Experimental | Procedure: Sleeve gastrectomy200 obesity patients who undergo laparoscopic sleeve gastrectomy |
| Roux-en-Y gastric bypass | Experimental | Procedure: Roux-en-Y gastric bypass200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve gastrectomyBariatric operation will be done by laparoscopic sleeve gastrectomy procedure. | Procedure or surgery | Sleeve gastrectomy |
| Roux-en-Y gastric bypassBariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure. | Procedure or surgery | Roux-en-Y gastric bypass |
Primary outcome
Obesity Cure Success Rate
Time frame: Postoperative 1 year
Proportion of patients who reach BMI bellow 25
Body weight change rate
Time frame: Postoperative 1 year
Decreased body weight proportion compare to preoperative body weight
Waist circumference change rate
Time frame: Postoperative 1 year
Decreased waist circumference change proportion compare to preoperative waist circumference
8 secondary outcomes
Rate of morbid disease remission or partial remission
Time frame: Postoperative 1 year, 2 year
Postoperative complication rate and mortality rate
Time frame: Within postoperative 30 days
Micronutrient deficiency
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-1
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-2
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-3
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-4
Time frame: Postoperative 1 year, 2 year
Quality of life improvement rate and degree-5
Time frame: Postoperative 1 year, 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon Seok Heo, Professor principal investigator
Inha University Hospital
Do Joong Park, Professor study director
Seoul National University Hospital
Yong Suk Park, Professor study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve gastrectomy and Roux-en-Y gastric bypass in people with Obesity, Morbid and Overnutrition, run by Inha University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoon Seok Heo, Professor (+82-32-890-3437, gsheo@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity Cure Success Rate (time frame: Postoperative 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.