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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

Tracking Information
First Submitted Date  ICMJE September 9, 2020
First Posted Date  ICMJE September 18, 2020
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • 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
  • 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
  • Micronutrient deficiency [ Time Frame: Postoperative 1 year, 2 year ]
    Incidence of micronutrient deficiency rate such as vitamine, calcium, iron
  • 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)
  • 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.
  • 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.
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2020)
  • Morbid disease improvement [ Time Frame: Postoperative 1 year, 2 year ]
    Remission or partial remission status of morbid disease related to obesity such as hypertension, type 2 DM, hyperlipidemia
  • Postoperative complication and mortality [ Time Frame: Within postoperative 30 days ]
    Surgical complications associate with the surgical technique or the operation field
  • Micronutrient deficiency [ Time Frame: Postoperative 1 year, 2 year ]
    Incidence of micronutrient deficiency rate such as vitamine, calcium, iron
  • Life quality change [ Time Frame: Postoperative 1 year, 2 year ]
    The improvement of life quality using several survey
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Comparative double arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity, Morbid
  • Overnutrition
  • Nutrition Disorders
  • Overweight and Obesity
  • Body Weight Changes
Intervention  ICMJE
  • Procedure: Sleeve gastrectomy
    Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
  • Procedure: Roux-en-Y gastric bypass
    Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.
Study Arms  ICMJE
  • Experimental: Sleeve gastrectomy
    200 obesity patients who undergo laparoscopic sleeve gastrectomy
    Intervention: Procedure: Sleeve gastrectomy
  • Experimental: Roux-en-Y gastric bypass
    200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass
    Intervention: Procedure: Roux-en-Y gastric bypass
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2020)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04554758
Other Study ID Numbers  ICMJE KOBESS-II trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yoonseok Heo, Inha University Hospital
Study Sponsor  ICMJE Inha University Hospital
Collaborators  ICMJE Korean Center for Disease Control and Prevention
Investigators  ICMJE
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
PRS Account Inha University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP