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Trial History Detail on 2014-08-07

CUHK_CCT00291

2011-11-29

Prospective

2011/11/29

None

The Chinese University of Hong Kong

N/A

Miss Joyce Chan

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

26838404

hychan@cuhk.edu.hk

Research Assistant, The Chinese University of Hong Kong

Dr. Alyssa Sze Wai Wong

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

26838404

alyssawong@cuhk.edu.hk

Honorary Clinical Assistant Professor, The Chinese University of Hong Kong

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

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

not available

Hong Kong

Yes

2011-05-03

Uterine fibroid

Drug

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

At the time of surgery only

Vasopressin

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).

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.

18

55

Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2011-12-01

40

Complete

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

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

No

2014-08-07

ChiCTR-TRC-11001784

2011-12-12


Yes

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