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

Not Applicable

• Conditions: Uterine Fibroid; Gonadotropin-Releasing Hormone-Dependent Precocious Puberty
• Interventions: Drug: PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS; Drug: NO GnRHa

• Registration Number: NCT04192812
• Lead Sponsor: Alkü Alanya Education and Research Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-21
• Last Update Posted: 2020-06-23
• Study Start: 2020-12-30
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• MYOMA UTERI
• APPROPİATE FOR LAPAROSCOPY

Exclusion Criteria

• MALİGNANCY

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GnRHa	PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS	3,75 MG LEUPROLIDE ACETATE FOR EVERY 4 WEEKS THROUGHOUT 3 MONTHS BEFORE SURGERY
no GnRHa	NO GnRHa	NO TREATMENT

Primary Outcome Measures

Name	Time	Method
AMOUNT OF BLEEDİNG	0 minute - 180 minute	WHOLE AMOUNT OF BLEEDING DURING SURGERY
DURATION AF SURGERY	0 MINUTE- 180 MINUTE	TIME BETWEEN INITIAL AND END OF SURGERY

Trial Locations

Locations (1)

Alku Alanya Education and Research Hospital; 🇹🇷 Antalya, Turkey