PREOPERATIVE GONADOTROPINE-RELEASING HORMONE AGONIST THERAPY BEFORE SURGERY FOR UTERİN FIBROIDS
THE EFFICACY OF PREOPERATIVE USAGE OF GONADOTROPINE-RELEASING HORMONE AGONIST IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedStudy Start
First participant enrolled
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJune 23, 2020
June 1, 2020
11 months
December 4, 2019
June 21, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
AMOUNT OF BLEEDİNG
WHOLE AMOUNT OF BLEEDING DURING SURGERY
0 minute - 180 minute
DURATION AF SURGERY
TIME BETWEEN INITIAL AND END OF SURGERY
0 MINUTE- 180 MINUTE
Study Arms (2)
GnRHa
EXPERIMENTAL3,75 MG LEUPROLIDE ACETATE FOR EVERY 4 WEEKS THROUGHOUT 3 MONTHS BEFORE SURGERY
no GnRHa
PLACEBO COMPARATORNO TREATMENT
Interventions
THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
Eligibility Criteria
You may qualify if:
- MYOMA UTERI
- APPROPİATE FOR LAPAROSCOPY
You may not qualify if:
- MALİGNANCY
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alku Alanya Education and Research Hospital
Antalya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MERAL TUĞBA ÇİMŞİR
ALKU EDUCATİON AND RESEARCH HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ASSOCIATE PROFESSOR
Study Record Dates
First Submitted
December 4, 2019
First Posted
December 10, 2019
Study Start
December 30, 2020
Primary Completion
December 1, 2021
Study Completion
December 30, 2021
Last Updated
June 23, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- 5 YEARS