CClinicalTrials.gg
Status unknownNCT02174185Updated Aug 4, 2014

Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders

An observational study in Bladder Cancer, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-04.

Sponsored by Huazhong University of Science and Technology · Observational

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of people living with bladder cancer. The findings from this study may help doctors and patients choosing the proper operation type.

02

Conditions studied

  • Bladder Cancer

Keywords

  • bladder cancer
  • conduit diversion
  • orthotopic neobladder
  • health-related quality of life
  • validated questionnaire
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 300 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All eligible patients in Wuhan Union Hospital, Huazhong University of Science and Technology.

Inclusion criteria

  • Clinical diagnosis of muscle invasive bladder cancer
  • Must be scheduled for radical cystectomy and subsequent conduit diversion or orthotopic neobladder
  • Must be able to provide informed consent
  • Must be 18 years of age or older
  • May have had received intravesical neoadjuvant, adjuvant chemotherapy or immunotherapy

Exclusion criteria

Exclusion Criteria:

  • Follow-up data not obtained at Wuhan Union Hospital
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • bladder cancer, conduit diversion

    new patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion

    Behavioral: validated health-related quality of life questionnaires

  • bladder cancer, orthotopic neobladder

    new patients with bladder cancer scheduled for radical cystectomy and subsequent orthotopic neobladder

    Behavioral: validated health-related quality of life questionnaires

Interventions

  • Behavioralvalidated health-related quality of life questionnaires

    All eligible patients who agree to participate will be asked to fulfill three different validated health-related quality of life questionnaires (EORTC-QLQ-C30/BLM, FACT-BL and BCI) prior to surgery and at 3, 6, 12, 18 months postoperatively.

06

What researchers measure

Primary outcomes

  1. Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions

    Time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively

Secondary outcomes

  1. Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL

    The aim is to compare three various validated tools of HRQoL to study their relative contributions in accounting for variance in prediction of patient HRQoL. The three validated tools of HRQoL are EORTC-QLQ-C30/BLM (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire/bladder cancer module), FACT-BL (Functional Assessment of Cancer Therapy-Bladder cancer) and BCI (Bladder Cancer Index). The two groups are conduit diversion group and orthotopic neobladder group.

    Time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively

  2. Score changes of each patient group during the follow-up

    Longitudinally learn about the changes of each individual patient HRQoL after urinary diversion and compare the changes of two groups, i.e. conduit diversion group and orthotopic neobladder group.

    Time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively

  3. Objective examination outcomes

    Supplement the assessment by interviewing the patients with some lab and image examinations, such as renal function tests, liver function tests, urine culture, urine cytology, chest radiography, ultrasound of kidney, ureter and bladder (KUB) etc.

    Time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively

07

Study locations

1 of 1 sites recruiting
  • Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
    • Xiaoping Zhang, MD, PhD · Contact · xzhang@hust.edu.cn · 86 27 85351625
    • Hangchuan Shi, MD · Contact · hangchuan_shi@hust.edu.cn · 86 13098893958
    • Xiaoping Zhang, MD,PhD · Principal investigator
    • Hangchuan Shi, MD · Principal investigator
    • Xiang Li, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02174185
Lead sponsor
Huazhong University of Science and Technology
Responsible party
Zhang Xiaoping (Director of Department of Urology, Wuhan Union Hospital, HUST, Huazhong University of Science and Technology) — Principal investigator
First posted
Jun 25, 2014
Start date
Aug 2014
Primary completion
Aug 2018 (estimated)
Completion
Aug 2018 (estimated)
Last update
Aug 4, 2014

Study contacts

Xiaoping Zhang, MD, PhD
Contact
xzhang@hust.edu.cn
86 27 85351625
Hangchuan Shi, MD
Contact
hangchuan_shi@hust.edu.cn
86 13098893958
Xiaoping Zhang, MD, PhD
study director · Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
Hangchuan Shi, MD
principal investigator · Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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