Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04554758
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-09-09
Brief Title:
Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation
Sponsor:
Inha University Hospital
Organization:
Inha University Hospital
Study Overview
Official Title:
Korean OBEsity Surgical Treatment StudyKOBESS-II Protocol of a Prospective Multicenter Cohort Study on Morbid Obesity Patients Undergoing Sleeve Gastrectomy Versus Roux-en Y Gastric Bypass
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 enrolledSleeve 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 25 gap started from 275
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
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 25 gap started from 275
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None