Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00523

2 Trial Registration Date

2016-08-19

i Registration Status

Prospective

3 Secondary IDs

CRE-2016.248

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

Dr. YEE Chi Hang

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Dr. Yee Chi Hang

ii Address

Divsion of Urology
Department of Surgery
The Chinese University of Hong Kong
4/F, LCW Clinical Sciences Building
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, N.T.
Hong Kong

iii Phone

35051663

iv Email

yeechihang@surgery.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Dr. YEE Chi Hang

ii Address

Divsion of Urology
Department of Surgery
The Chinese University of Hong Kong
4/F, LCW Clinical Sciences Building
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, N.T.
Hong Kong

iii Phone

35051663

iv Email

yeechihang@surgery.cuhk.edu.hk

v Affiliation

Division of Urology, Department of Surgery, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Prevention of lymphocele with Floseal in renal transplantation: A multicentre randomized controlled trial

10 Public Title

Prevention of lymphocele with Floseal in renal transplantation: A multicentre randomized controlled trial

i Public Title in Chinese 研究名稱

伏血凝止血劑對腎移植後淋巴囊腫之避免的多中心隨機對照試

11 Short Title (Optional)

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?

2016-06-23

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2016.248

14 Medical Condition Being Studied

Renal transplantation

Lymphocele

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

FloSeal®

iii Dosage form of the intervention

Not applicable

iv Dosage of the intervention

Not applicable

v Duration of the intervention

Non-specific

vi Frequency of the intervention

Once intra-operation

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Male or female patients older than 18 years old, with end-stage renal failure fit for renal transplantation.

Renal transplantation candidates in PWH, PMH or QMH.

ii Exclusion Criteria

Allergy or adverse reaction to FloSeal®.

iii Age Minimum

18

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Subjects will be randomized in 1:1 ratio into two arms for study intervention or non-intervention

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

To compare the incidence of symptomatic lymphocele after renal transplantation between the FloSeal® group and non-FloSeal® group.

20 Anticipated trial start date

2016-09-01

21 Target Sample Size

110

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

To compare the incidence of symptomatic lymphocele after renal transplantation between the FloSeal® group and non-FloSeal® group.

ii The metric or method of measurement used

Outcome is evaluated by documenting any events of symptomatic lymphocele after renal transplantation leading to comlications requiring interventions

iii The timepoint(s) of primary interest

6 months post surgery

24 Secondary Outcome

i The Name of the outcome

Complications and adverse events of renal transplantation

ii The metric or method of measurement used

Incidence of asymptomatic lymphocele and their sizes will be assessed by ultrasonography done at 3 months post operation.

iii The timepoint(s) of primary interest

2 months post operation

Secondary Outcome

i The Name of the outcome

Post-operative drain output

ii The metric or method of measurement used

The total drain output will be measured.

iii The timepoint(s) of primary interest

Post surgery until the drain is removed

Secondary Outcome

i The Name of the outcome

Post-operative hospital stay

ii The metric or method of measurement used

Number of days of hospital stay post surgery will be recorded.

iii The timepoint(s) of primary interest

Until patient is discharged from hospital

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-05-31

27 Primary Registry and Trial Identifying Number

ChiCTR-IIR-16009066

28 Date of Registration in Primary Registry

2016-08-19

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Trial History Detail on 2017-08-30