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PREOPERATIVE GONADOTROPINE-RELEASING HORMONE AGONIST THERAPY BEFORE SURGERY FOR UTERİN FIBROIDS

A

Alkü Alanya Education and Research Hospital

Status

Unknown

Conditions

Gonadotropin-Releasing Hormone-Dependent Precocious Puberty
Uterine Fibroid

Treatments

Drug: PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS
Drug: NO GnRHa

Study type

Interventional

Funder types

Other

Identifiers

NCT04192812
ALKU RESEARCH HOSPİTAL

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

Female

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • MYOMA UTERI
  • APPROPİATE FOR LAPAROSCOPY

Exclusion criteria

  • MALİGNANCY

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

GnRHa
Experimental group
Description:
3,75 MG LEUPROLIDE ACETATE FOR EVERY 4 WEEKS THROUGHOUT 3 MONTHS BEFORE SURGERY
Treatment:
Drug: PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS
no GnRHa
Placebo Comparator group
Description:
NO TREATMENT
Treatment:
Drug: NO GnRHa

Trial contacts and locations

1

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Central trial contact

MERAL TUĞBA ÇİMŞİR

Data sourced from clinicaltrials.gov

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