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

Uterine Fibroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04192812
• Other study ID #: ALKU RESEARCH HOSPITAL
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2020
• Source: Alkü Alanya Education and Research Hospital
• Contact: MERAL TUGBA ÇIMSIR
• Phone: 05064742272
• Email: dr.tugbaacar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• MYOMA UTERI

• APPROPIATE FOR LAPAROSCOPY

Exclusion Criteria:

• MALIGNANCY

Related Conditions & MeSH terms

• Gonadotropin-Releasing Hormone-Dependent Precocious Puberty
• Leiomyoma
• Puberty, Precocious
• Uterine Fibroid

Intervention

Drug:
• PREOPERATIVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERIN FIBROIDS
THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
• NO GnRHa
THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS

Locations

Country	Name	City	State
Turkey	Alku Alanya Education and Research Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Alkü Alanya Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMOUNT OF BLEEDING	WHOLE AMOUNT OF BLEEDING DURING SURGERY	0 minute - 180 minute
Primary	DURATION AF SURGERY	TIME BETWEEN INITIAL AND END OF SURGERY	0 MINUTE- 180 MINUTE