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

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04554758
• Other study ID #: KOBESS-II trial
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2020
• Source: Inha University Hospital
• Contact: Yoon Seok Heo, Professor
• Phone: +82-32-890-3437
• Email: gsheo[@]inha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Sleeve gastrectomy
Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
• Roux-en-Y gastric bypass
Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (2)

Lead Sponsor	Collaborator
Inha University Hospital	Korean Center for Disease Control and Prevention

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obesity Cure Success Rate	Proportion of patients who reach BMI bellow 25	Postoperative 1 year
Primary	Body weight change rate	Decreased body weight proportion compare to preoperative body weight	Postoperative 1 year
Primary	Waist circumference change rate	Decreased waist circumference change proportion compare to preoperative waist circumference	Postoperative 1 year
Secondary	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 1 year, 2 year
Secondary	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	Within postoperative 30 days
Secondary	Micronutrient deficiency	Incidence of micronutrient deficiency rate such as vitamine, calcium, iron	Postoperative 1 year, 2 year
Secondary	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)	Postoperative 1 year, 2 year
Secondary	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.	Postoperative 1 year, 2 year
Secondary	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.	Postoperative 1 year, 2 year
Secondary	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.	Postoperative 1 year, 2 year
Secondary	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)	Postoperative 1 year, 2 year