Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00298

2 Trial Registration Date

2011-09-22

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Health and medical research Fund (formerly: Health and Health Services Research Fund)

5 Primary Sponsor

Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

NG Chi Fai

ii Address

4/F., Clinical science building, PWH

iii Phone

26322625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

NG Chi Fai

ii Address

4/F., Clinical science building, PWH

iii Phone

26322625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

Short stay transurethral prostate surgery: A randomized controlled trial comparing bipolar transurethral vaporization of prostate with monopolar transurethral resection

10 Public Title

Short stay transurethral prostate surgery: A randomized controlled trial comparing bipolar transurethral vaporization of prostate with monopolar transurethral resection

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Short stay transurethral prostate surgery

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-01-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Benign prostatic hyperplasia

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Bipolar transurethral vaporization of prostate

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 day

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Monopolar transurethral resection

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

• Men aged 50 to ≤70, with benign prostatic hyperplasia,
• American Association of Anesthesiology Class ≤ 2,
• Compliant patients
o Activities of daily living independent or largely independent
o Agreeable to principle of short stay surgery
o Ready to be discharged to home (not institute) upon clinical decision of discharge
o Social support available to facilitate early discharge
o assess to hospital care within 15 minutes of travel,
AND
• One of the following:
o Failed medical therapy with alpha-blockers or 5-alpha reductase inhibitors, with International Prostate Symptoms Score (IPSS) ≥ 18 and/or maximal flow rate (Qmax) ≤ 15ml/s, OR
o Acute urinary retention

ii Exclusion Criteria

• Previous history of TURP or other forms of intervention for benign prostate hyperplasia
• Patient confirmed to have carcinoma of prostate
• Patients with neurogenic bladder, bladder stone, diverticula or urethral stricture requiring concomitant surgery

iii Age Minimum

50

iv Age Maximum

70

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-11-01

21 Target Sample Size

168

22 Recruitment Status

Complete

23 Primary Outcome

Clinically hospital stay post-surgery

24 Secondary Outcome

catheter time, dysuria score and maximal flow at 3, 6, 12 months post-surgery.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001656

28 Date of Registration in Primary Registry

2011-11-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-04-08