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

NCT ID: NCT04192812

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-30

Study Completion Date

2021-12-30

Brief Summary

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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

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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.

Conditions

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Uterine Fibroid Gonadotropin-Releasing Hormone-Dependent Precocious Puberty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

PROSPECTİVE RANDOMİSED CONTROLLED TRİAL
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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GnRHa

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

Group Type EXPERIMENTAL

PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS

Intervention Type DRUG

THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS

no GnRHa

NO TREATMENT

Group Type PLACEBO_COMPARATOR

NO GnRHa

Intervention Type DRUG

THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS

Interventions

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PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS

THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS

Intervention Type DRUG

NO GnRHa

THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* MYOMA UTERI
* APPROPİATE FOR LAPAROSCOPY

Exclusion Criteria

* MALİGNANCY
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alkü Alanya Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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MERAL TUĞBA ÇİMŞİR

ASSOCIATE PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MERAL TUĞBA ÇİMŞİR

Role: PRINCIPAL_INVESTIGATOR

ALKU EDUCATİON AND RESEARCH HOSPITAL

Locations

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Alku Alanya Education and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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MERAL TUĞBA ÇİMŞİR

Role: CONTACT

05064742272

Facility Contacts

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MERAL TUĞBA ÇİMŞİR

Role: primary

Other Identifiers

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ALKU RESEARCH HOSPİTAL

Identifier Type: -

Identifier Source: org_study_id

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