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

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

Tracking Information

• First Submitted Date: September 9, 2020
• First Posted Date: September 18, 2020
• Last Update Posted Date: October 8, 2020
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: August 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Comparative double arm study

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Obesity, Morbid
• Overnutrition
• Nutrition Disorders
• Overweight and Obesity
• Body Weight Changes

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 13, 2020): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2023
• Estimated Primary Completion Date: August 31, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: Korea, Republic of

Administrative Information

• NCT Number: NCT04554758
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Yoonseok Heo, Inha University Hospital
• Study 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

• PRS Account: Inha University Hospital
• Verification Date: October 2020