Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00291

2 Trial Registration Date

2011-11-29

i Registration Status

Prospective

3 Secondary IDs

2011/11/29

4 Source(s) of Funding

None

5 Primary Sponsor

The 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

Miss Joyce Chan

ii Address

3/F, O&G Office, North District Hospital

iii Phone

26838404

iv Email

hychan@cuhk.edu.hk

v Affiliation

Research Assistant, The Chinese University of Hong Kong

vi Country

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

i Name

Dr. Alyssa Sze Wai Wong

ii Address

3/F, O&G Office, North District Hospital

iii Phone

26838404

iv Email

alyssawong@cuhk.edu.hk

v Affiliation

Honorary Clinical Assistant Professor, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Use of a new method of vasopressin injection compared to placebo in Hysteroscopic myomectomy. A prospective randomized double-blind controlled study

10 Public Title

Use of a new method of vasopressin injection compared to placebo in Hysteroscopic myomectomy. A prospective randomized double-blind controlled study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

not available

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?

2011-05-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Uterine fibroid

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

This study aims to investigate the effect of direct infiltration of vasopressin to reduce operative blood loss, operative time, improve visualization and reduce distension fluid intravasation during hysteroscopic myomectomy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

At the time of surgery only

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Vasopressin

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

Premenopausal women with symptomatic submucous fibroid will be recruited in the study. The diagnosis of submucous fibroid will be made by transvaginal ultrasound and diagnostic hysteroscopy. The size of the submucous fibroid will be measured by ultrasound. Hysteroscopic myomectomy will be performed for fibroids less than 5cm in size. The type of submucous fibroid will be determined by ultrasound and hysteroscopy using the Wamsteker classification(13).

ii Exclusion Criteria

Menopausal women, patients with endometrial premalignant or malignant pathologies, patients who require endometrial ablation, or on anticoagulant therapy, patients with cardiovascular diseases, migraine, asthma, heart failure, epilepsy and patients unwilling to participate will be excluded from the study. Women<18 years old will not be recruited.

iii Age Minimum

18

iv Age Maximum

55

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

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

2011-12-01

21 Target Sample Size

40

22 Recruitment Status

Recruiting

23 Primary Outcome

Primary outcome measures
 Surgical time: cervical dilatation/myomectomy/polypectomy
 Fluid difference, intravasation of distending fluid

24 Secondary Outcome

Secondary outcome mesures
 Intraoperative blood loss
 Drop in hemoglobin level
 Complete excision
 Intraoperative complication
 Postoperative complication and Length of hospital stay

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-08-07

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001784

28 Date of Registration in Primary Registry

2011-12-12

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

nil

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Trial History Detail on 2013-01-08