THE EFFICACY OF PREOPERATIVE USAGE OF GONADOTROPINE-RELEASING HORMONE AGONIST IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
Overview
- Phase
- Not Applicable
- Sponsor
- Alkü Alanya Education and Research Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- AMOUNT OF BLEEDİNG
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •MYOMA UTERI
- •APPROPİATE FOR LAPAROSCOPY
Exclusion Criteria
- •MALİGNANCY
Arms & Interventions
GnRHa
3,75 MG LEUPROLIDE ACETATE FOR EVERY 4 WEEKS THROUGHOUT 3 MONTHS BEFORE SURGERY
Intervention: PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS (Drug)
no GnRHa
NO TREATMENT
Intervention: NO GnRHa (Drug)
Outcomes
Primary Outcomes
AMOUNT OF BLEEDİNG
Time Frame: 0 minute - 180 minute
WHOLE AMOUNT OF BLEEDING DURING SURGERY
DURATION AF SURGERY
Time Frame: 0 MINUTE- 180 MINUTE
TIME BETWEEN INITIAL AND END OF SURGERY
Secondary Outcomes
No secondary outcomes reported
Investigators
MERAL TUĞBA ÇİMŞİR
ASSOCIATE PROFESSOR
Alkü Alanya Education and Research Hospital