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Trial History Detail on 2016-09-02

CUHK_CCRB00523

2016-08-19

Prospective

CRE-2016.248

The Chinese University of Hong Kong

Dr. YEE Chi Hang

N/A

Not Applicable

Lam Nga Yee

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

26321663

nylam@surgery.cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Dr. YEE Chi Hang

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

26322625

yeechihang@surgery.cuhk.edu.hk

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

Hong Kong

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

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

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

Hong Kong

Yes

2016-06-23

Joint CUHK-NTEC Clinical Research Ethics Committee

CRE-2016.248

Renal transplantation

Lymphocele

Device

FloSeal®

Not applicable

Not applicable

Non-specific

Once intra-operation

N/A

N/A

N/A

N/A

N/A

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.

Allergy or adverse reaction to FloSeal®.

18

N/A

Both Male and Female

Interventional

Randomized

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

Active

Open label

Parallel

4

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

2016-09-01

110

Not Yet Recruiting

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

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

6 months post surgery

Complications and adverse events of renal transplantation

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

3 months post operation

Post-operative drain output

The total drain output will be measured.

Post surgery until the drain is removed

Post-operative hospital stay

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

Until patient is discharged from hospital

No

2021-05-31

ChiCTR-IIR-16009066

2016-08-19

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