Prospective Data on Bariatric Surgery Effect on IPSS and LUTS

NCT06464822 | Recruiting

• 1 other identifier: CREC 2008.497-T
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

To establish a central database on clinical parameters for patients who has morbid obesity, which aiming at

1. 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. 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. 3.To compare outcome with the regional/international center databse for benchmarking performance of HK bariatric surgery

Conditions

Bariatric Surgery Candidate; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Control Group

For patients decide not for bariatric surgery

Intervention Group

For patient decided for Bariatric surgery

Procedure: Bariatric Surgery

Interventions

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)

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Alex Qinyang Liu, MBBS

CONTACT

97582233; alexliu@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 18, 2024
• Study Start: January 1, 2008
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

HK (1)