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

Primary Purpose

Uterine Fibroid, Gonadotropin-Releasing Hormone-Dependent Precocious Puberty

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS
NO GnRHa
Sponsored by
Alkü Alanya Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroid

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • MYOMA UTERI
  • APPROPİATE FOR LAPAROSCOPY

Exclusion Criteria:

  • MALİGNANCY

Sites / Locations

  • Alku Alanya Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GnRHa

no GnRHa

Arm Description

3,75 MG LEUPROLIDE ACETATE FOR EVERY 4 WEEKS THROUGHOUT 3 MONTHS BEFORE SURGERY

NO TREATMENT

Outcomes

Primary Outcome Measures

AMOUNT OF BLEEDİNG
WHOLE AMOUNT OF BLEEDING DURING SURGERY
DURATION AF SURGERY
TIME BETWEEN INITIAL AND END OF SURGERY

Secondary Outcome Measures

Full Information

First Posted
December 4, 2019
Last Updated
June 21, 2020
Sponsor
Alkü Alanya Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04192812
Brief Title
PREOPERATIVE GONADOTROPINE-RELEASING HORMONE AGONIST THERAPY BEFORE SURGERY FOR UTERİN FIBROIDS
Official Title
THE EFFICACY OF PREOPERATIVE USAGE OF GONADOTROPINE-RELEASING HORMONE AGONIST IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alkü Alanya Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid, Gonadotropin-Releasing Hormone-Dependent Precocious Puberty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
PROSPECTİVE RANDOMİSED CONTROLLED TRİAL
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GnRHa
Arm Type
Experimental
Arm Description
3,75 MG LEUPROLIDE ACETATE FOR EVERY 4 WEEKS THROUGHOUT 3 MONTHS BEFORE SURGERY
Arm Title
no GnRHa
Arm Type
Placebo Comparator
Arm Description
NO TREATMENT
Intervention Type
Drug
Intervention Name(s)
PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS
Intervention Description
THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
Intervention Type
Drug
Intervention Name(s)
NO GnRHa
Intervention Description
THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
Primary Outcome Measure Information:
Title
AMOUNT OF BLEEDİNG
Description
WHOLE AMOUNT OF BLEEDING DURING SURGERY
Time Frame
0 minute - 180 minute
Title
DURATION AF SURGERY
Description
TIME BETWEEN INITIAL AND END OF SURGERY
Time Frame
0 MINUTE- 180 MINUTE

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: MYOMA UTERI APPROPİATE FOR LAPAROSCOPY Exclusion Criteria: MALİGNANCY
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MERAL TUĞBA ÇİMŞİR
Phone
05064742272
Email
dr.tugbaacar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MERAL TUĞBA ÇİMŞİR
Organizational Affiliation
ALKU EDUCATİON AND RESEARCH HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alku Alanya Education and Research Hospital
City
Antalya
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MERAL TUĞBA ÇİMŞİR
Phone
05064742272
Email
DR.TUGBAACAR@GMAİL.COM

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
5 YEARS

Learn more about this trial

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

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