AzTrials
AzTrials

Bariatric Surgery CandidateNCT06464822

Prospective Data on Bariatric Surgery Effect on IPSS and LUTS

An observational study of Bariatric Surgery Candidate and Lower Urinary Tract Symptoms, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bariatric Surgery
Type of treatment
Surgery or procedure
How many people
5,000 participants
Where
1 siteHong Kong
Study dates
1 Jan 2008to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alex Qinyang Liu, MBBS contact

97582233

alexliu@surgery.cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Prince of Wales Hospital

    Hong Kong, 999077

    Shirley Liu, FRCS, liuyw@surgery.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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
Read the 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.

Being tested
Bariatric Surgery
Medical subject headings
Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bariatric SurgeryProcedure or 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)

Study groups in NCT06464822
Study groupRoleWhat they receive
Control GroupFor patients decide not for bariatric surgery
Intervention GroupFor patient decided for Bariatric surgery
Receives: Procedure: Bariatric Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IPSS

    International prostate symptom score

    Measured: Annually up to 10 years post-operatively

  2. BMI

    Body mass index

    Measured: Annually up to 10 years post-operatively

  3. Percentage excess body weight loss

    The amount of body mass lost due to bariatric surgery

    Measured: Annually up to 10 years post-operatively

  4. Short Form Health Survey

    SF 36

    Measured: Annually up to 10 years post-operatively

  5. Eating Disorder Examination Questionnaire

    EDE-Q

    Measured: Annually up to 10 years post-operatively

  6. Adverse events

    Side effect / new symptom after surgery

    Measured: Up to 30 days post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start1 Jan 2008
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06464822
Sponsor's protocol ID
CREC 2008.497-T
Status last verified
Jun 2024
First submitted
7 Jun 2024
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery Candidate and Lower Urinary Tract Symptoms, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alex Qinyang Liu, MBBS (97582233, alexliu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IPSS (time frame: Annually up to 10 years post-operatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in