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

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ClinicalTrials.gov Identifier: NCT04554758
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Korean Center for Disease Control and Prevention
Information provided by (Responsible Party):
Yoonseok Heo, Inha University Hospital

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

Condition or disease Intervention/treatment Phase
Obesity, Morbid Overnutrition Nutrition Disorders Overweight and Obesity Body Weight Changes Procedure: Sleeve gastrectomy Procedure: Roux-en-Y gastric bypass Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparative double arm study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Obesity Cure Success Rate [ Time Frame: Postoperative 1 year ]
    Proportion of patients who reach BMI bellow 25

  2. Body weight change rate [ Time Frame: Postoperative 1 year ]
    Decreased body weight proportion compare to preoperative body weight

  3. Waist circumference change rate [ Time Frame: Postoperative 1 year ]
    Decreased waist circumference change proportion compare to preoperative waist circumference


Secondary Outcome Measures :
  1. Rate of morbid disease remission or partial remission [ Time Frame: Postoperative 1 year, 2 year ]
    Remission rate or partial remission rate of morbid disease related to obesity such as hypertension, type 2 diabetes mellitus, hyperlipidemia after surgery

  2. Postoperative complication rate and mortality rate [ Time Frame: Within postoperative 30 days ]
    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

  3. Micronutrient deficiency [ Time Frame: Postoperative 1 year, 2 year ]
    Incidence of micronutrient deficiency rate such as vitamine, calcium, iron

  4. Quality of life improvement rate and degree-1 [ Time Frame: Postoperative 1 year, 2 year ]

    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)


  5. Quality of life improvement rate and degree-2 [ Time Frame: Postoperative 1 year, 2 year ]

    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.


  6. Quality of life improvement rate and degree-3 [ Time Frame: Postoperative 1 year, 2 year ]

    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.


  7. Quality of life improvement rate and degree-4 [ Time Frame: Postoperative 1 year, 2 year ]

    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.


  8. Quality of life improvement rate and degree-5 [ Time Frame: Postoperative 1 year, 2 year ]

    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)



Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554758


Contacts
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Contact: Yoon Seok Heo, Professor +82-32-890-3437 gsheo@inha.ac.kr
Contact: Yun Suk Choi, Instructor +82-32-890-3437 yunsukki@gmail.com

Locations
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Korea, Republic of
Inha University Hospital Recruiting
Incheon, Korea, Republic of
Contact: Yoon Seok Heo, Professor    +82-32-890-3435    gsheo@inha.ac.kr   
Sponsors and Collaborators
Inha University Hospital
Korean Center for Disease Control and Prevention
Investigators
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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
More Information
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Responsible Party: Yoonseok Heo, Professor, Inha University Hospital
ClinicalTrials.gov Identifier: NCT04554758    
Other Study ID Numbers: KOBESS-II trial
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yoonseok Heo, Inha University Hospital:
primary bariatric surgery
morbid obesity
sleeve gastrectomy
Roux-en Y gastric bypass
South Korea
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Nutrition Disorders
Overnutrition
 Overweight
Body Weight
Body Weight Changes