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临床试验/NCT04192812
NCT04192812Unknown不适用

THE EFFICACY OF PREOPERATIVE USAGE OF GONADOTROPINE-RELEASING HORMONE AGONIST IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS

Alkü Alanya Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
AMOUNT OF BLEEDİNG

研究概览

简要总结

Uterin fibroids are the most common operation indication for hysterectomy. Dyring laparoscopic hysterectomy the amount of bleeding is a great difficulty.There are a lot of clinical researchs to reduce the haemorrhage during open hysterectomy but not laparoscopic procedure. In ALKU ERH clinic, researchers decided to smaller the size of fibroid by using GnRH analogues before total laparoscopic hysterectomy to reduce the haemorrhage amount.

详细描述

After randomising patients to two groups, one of the group will be controle group and the other group will be working group and researchers decided to use 3,75 mg leuprolide acetate as GnRHa subcutanously in every four week, throughout 3 months before surgery to the working group, researchers will record intraoperative amount of bleeding by measuring the blood in suction scale, the duration of surgery, difference between preoperative haemoglobin levels and uterin weight. researchers will comparise all theese parameters ibn to two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • MYOMA UTERI
  • APPROPİATE FOR LAPAROSCOPY

排除标准

  • MALİGNANCY

研究组 & 干预措施

GnRHa

Experimental

3,75 MG LEUPROLIDE ACETATE FOR EVERY 4 WEEKS THROUGHOUT 3 MONTHS BEFORE SURGERY

干预措施: PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS (Drug)

no GnRHa

Placebo Comparator

NO TREATMENT

干预措施: NO GnRHa (Drug)

结局指标

主要结局

AMOUNT OF BLEEDİNG

时间窗: 0 minute - 180 minute

WHOLE AMOUNT OF BLEEDING DURING SURGERY

DURATION AF SURGERY

时间窗: 0 MINUTE- 180 MINUTE

TIME BETWEEN INITIAL AND END OF SURGERY

次要结局

未报告次要终点

研究者

发起方
Alkü Alanya Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

MERAL TUĞBA ÇİMŞİR

ASSOCIATE PROFESSOR

Alkü Alanya Education and Research Hospital

研究点 (1)

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