Prospective Data on Bariatric Surgery Effect on IPSS and LUTS

Prospective Data-Collection for Assessment on Efficacy of Invasive Weight Management Program for Morbidly Obese Patients - IPSS and LUTS

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 regional/international center databse for benchmarking performance of HK bariatric surgery

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: 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 surgery's 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 regional/international 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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Alex Qinyang Liu, MBBS; Phone Number: 97582233; Email: alexliu@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Shirley Liu, FRCS; Email: liuyw@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who has morbid obesity and attended bariatric clinic of Prince of Wales Hospital

Description

Inclusion Criteria

1. Patients with BMI >25
2. Patient who attended either the PWH Multidiciplinary Clinic of Metabolic & Bariatric Surgery to seek for treatment of severe obesity.
3. Consented patients (age >18).

Exclusion Criteria

1. Patient unable or unwilling to give written consent
2. Special population, e.g. prisoner, mentally disabled, investigators' student or employees.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; For patients decide not for bariatric surgery
Intervention Group; For patient decided for Bariatric surgery	Procedure: Bariatric Surgery; weight control procedures, including intragastric balloon (IGT) [5], laparoscopic adjustable gastric banding (LAGB) [6], laparoscopic gastric bypass (LGB) operation and laparoscopic sleeve gastrectomy (LSG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPSS	International prostate symptom score	Annually up to 10 years post-operatively
BMI	Body mass index	Annually up to 10 years post-operatively
Percentage excess body weight loss	The amount of body mass lost due to bariatric surgery	Annually up to 10 years post-operatively
Short Form Health Survey	SF 36	Annually up to 10 years post-operatively
Eating Disorder Examination Questionnaire	EDE-Q	Annually up to 10 years post-operatively
Adverse events	Side effect / new symptom after surgery	Up to 30 days post-operatively

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: CREC 2008.497-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data on individual participants and the study protocol will be available to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in an approved and methodologically sound proposal. Data requestors needing to sign a data access agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No