Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464822
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-07
Brief Title:
Prospective Data on Bariatric Surgery Effect on IPSS and LUTS
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Prospective Data-Collection for Assessment on Efficacy of Invasive Weight Management Program for Morbidly Obese Patients - IPSS and LUTS
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
To establish a central database on clinical parameters for patients who has morbid obesity which aiming at
1 to compare the results of those with or without receiving invasive bariatric treatment in Prince of Wales Hospital Multidiciplinary Clinic of Metabolic Bariatric Surgery and CUHK Medical Centre Weight Management Metabolic Surgery Clinic
2 To audit and compare outcome between PWH CUHK Medical Centre and with other bariatric surgery centers in Hong Kong Hong Kong Bariatric Metabolic Surgery Registry
3 To compare outcome with the regionalinternational center databse for benchmarking performance of HK bariatric surgery
1 to compare the results of those with or without receiving invasive bariatric treatment in Prince of Wales Hospital Multidiciplinary Clinic of Metabolic Bariatric Surgery and CUHK Medical Centre Weight Management Metabolic Surgery Clinic
2 To audit and compare outcome between PWH CUHK Medical Centre and with other bariatric surgery centers in Hong Kong Hong Kong Bariatric Metabolic Surgery Registry
3 To compare outcome with the regionalinternational center databse for benchmarking performance of HK bariatric surgery
Detailed Description:
Morbid obesity causes or exacerbates many diseases DM HT sleep apnea atherosclerosis etc and is associated with major physical and psychosocial disability 1 Moreover ethnic background can also affect BMI-related disease risk as Southeast Asia populations have a higher risk of developing diabetes and cardiovascular disease than do Caucasian who have the same BMI values 2 Non-surgical intervention like diet and exercise plus augmented by drug therapy and behavioral modification often provide an unsustainable and insufficient weight loss in morbidly obese patients BMI 40 The benefits of bariatric surgery is the effectiveness in achieving substantial 50 excessive body weight loss and sustainable weight control and improve co-morbidity and overall survival 3 5 4
The Department of Surgery of CUHK is a pioneer in the development of bariatric surgery in Hong Kong Since 2001 the investigators have introduced a variety of weight control procedures including intragastric balloon IGT 5 laparoscopic adjustable gastric banding LAGB 6 laparoscopic gastric bypass LGB operation and laparoscopic sleeve gastrectomy LSG 7 in the region Currently the investigators are holding the greatest volume of obesity cases and operative experience in this clinical subspecialty within Hong Kong There is no comparable institution in HK as far as expertise in bariatric surgerys concerned Since 2001 the investigators have received 510 referrals for bariatric surgery and have performed more than 220 operations thus far without mortality The investigators foresee that the demand for such surgery is going to be huge in the future especially in China The number of cases treated reveals that the trend is on the increase Furthermore the Union Hospital has since inauguration been a working and training partner of the Faculty of Medicine CUHK In 2006 UH has established her weight management center and with the collaboration between her and CUHK the investigators had established the Joint bariatric surgery research center in 2007 This collaboration provided us rooms for further development in the field of bariatric surgery
Up till now our initial results of previous prospective cohort received these procedures were promising without operative mortality In a recent audit on our bariatric surgery service the mean excessive weight loss for procedures LAGB LSG and LGB were 34 51 and 61 at 2 years respectively 8 In order to maintain the optimal outcome and seek for rooms of improvement a proper data collection for both research and auditing for PWH CUHK MC HK local audit for bench marking with international standard is necessary
In order to extend our research and data collection for analysis the investigators would like to set up a central database on patients who seeks for or received interventional bariatric procedures
Objective To establish a central database on clinical parameters for patients who has morbid obesity which aiming at
1 to compare the results of those with or without receiving invasive bariatric treatment in Prince of Wales Hospital Multidiciplinary Clinic of Metabolic Bariatric Surgery and CUHK Medical Centre Weight Management Metabolic Surgery Clinic
2 To audit and compare outcome between PWH CUHK Medical Centre and with other bariatric surgery centers in Hong Kong Hong Kong Bariatric Metabolic Surgery Registry
3 To compare outcome with the regionalinternational center databse for benchmarking performance of HK bariatric surgery
Study design Prospective cohort study
Sample size Since the current protocol is a prospective data collection of all bariatric surgical patients the investigators estimate the yearly recruitment is approximately 200-250 patients The investigators will not set limitation on the number of subjects recruited but will review this protocol every 5 years for necessary amendment and update
The Department of Surgery of CUHK is a pioneer in the development of bariatric surgery in Hong Kong Since 2001 the investigators have introduced a variety of weight control procedures including intragastric balloon IGT 5 laparoscopic adjustable gastric banding LAGB 6 laparoscopic gastric bypass LGB operation and laparoscopic sleeve gastrectomy LSG 7 in the region Currently the investigators are holding the greatest volume of obesity cases and operative experience in this clinical subspecialty within Hong Kong There is no comparable institution in HK as far as expertise in bariatric surgerys concerned Since 2001 the investigators have received 510 referrals for bariatric surgery and have performed more than 220 operations thus far without mortality The investigators foresee that the demand for such surgery is going to be huge in the future especially in China The number of cases treated reveals that the trend is on the increase Furthermore the Union Hospital has since inauguration been a working and training partner of the Faculty of Medicine CUHK In 2006 UH has established her weight management center and with the collaboration between her and CUHK the investigators had established the Joint bariatric surgery research center in 2007 This collaboration provided us rooms for further development in the field of bariatric surgery
Up till now our initial results of previous prospective cohort received these procedures were promising without operative mortality In a recent audit on our bariatric surgery service the mean excessive weight loss for procedures LAGB LSG and LGB were 34 51 and 61 at 2 years respectively 8 In order to maintain the optimal outcome and seek for rooms of improvement a proper data collection for both research and auditing for PWH CUHK MC HK local audit for bench marking with international standard is necessary
In order to extend our research and data collection for analysis the investigators would like to set up a central database on patients who seeks for or received interventional bariatric procedures
Objective To establish a central database on clinical parameters for patients who has morbid obesity which aiming at
1 to compare the results of those with or without receiving invasive bariatric treatment in Prince of Wales Hospital Multidiciplinary Clinic of Metabolic Bariatric Surgery and CUHK Medical Centre Weight Management Metabolic Surgery Clinic
2 To audit and compare outcome between PWH CUHK Medical Centre and with other bariatric surgery centers in Hong Kong Hong Kong Bariatric Metabolic Surgery Registry
3 To compare outcome with the regionalinternational center databse for benchmarking performance of HK bariatric surgery
Study design Prospective cohort study
Sample size Since the current protocol is a prospective data collection of all bariatric surgical patients the investigators estimate the yearly recruitment is approximately 200-250 patients The investigators will not set limitation on the number of subjects recruited but will review this protocol every 5 years for necessary amendment and update
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