Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06464822

Prospective Data on Bariatric Surgery Effect on 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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong, 999077

Location status: Recruiting

Location contact

Shirley Liu, FRCS

CONTACT

[email protected]

About this study

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

  • 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).
  • 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)
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

bariatric surgery

Procedure

weight control procedures, including intragastric balloon (IGT) [5], laparoscopic adjustable gastric banding (LAGB) [6], laparoscopic gastric bypass (LGB) operation and laparoscopic sleeve gastrectomy (LSG)

Primary outcomes

  1. IPSS

    Time frame: Annually up to 10 years post-operatively

    International prostate symptom score

  2. BMI

    Time frame: Annually up to 10 years post-operatively

    Body mass index

  3. Percentage excess body weight loss

    Time frame: Annually up to 10 years post-operatively

    The amount of body mass lost due to bariatric surgery

  4. Short Form Health Survey

    Time frame: Annually up to 10 years post-operatively

    SF 36

  5. Eating Disorder Examination Questionnaire

    Time frame: Annually up to 10 years post-operatively

    EDE-Q

  6. Adverse events

    Time frame: Up to 30 days post-operatively

    Side effect / new symptom after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Qinyang Liu, MBBS

CONTACT

[email protected]

97582233

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2029
Study completion
2029
First posted
Jun 18, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.