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

June 21, 2020 updated by: MERAL TUĞBA ÇİMŞİR, Alkü Alanya Education and Research Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Alku Alanya Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • MYOMA UTERI
  • APPROPİATE FOR LAPAROSCOPY

Exclusion Criteria:

  • MALİGNANCY

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GnRHa
3,75 MG LEUPROLIDE ACETATE FOR EVERY 4 WEEKS THROUGHOUT 3 MONTHS BEFORE SURGERY
Drug: 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
Placebo Comparator: no GnRHa
NO TREATMENT
Drug: NO GnRHa
THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMOUNT OF BLEEDİNG
Time Frame: 0 minute - 180 minute
WHOLE AMOUNT OF BLEEDING DURING SURGERY
0 minute - 180 minute
DURATION AF SURGERY
Time Frame: 0 MINUTE- 180 MINUTE
TIME BETWEEN INITIAL AND END OF SURGERY
0 MINUTE- 180 MINUTE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkü Alanya Education and Research Hospital

Investigators

  • Principal Investigator: MERAL TUĞBA ÇİMŞİR, ALKU EDUCATİON AND RESEARCH HOSPITAL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 21, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKU RESEARCH HOSPİTAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

5 YEARS

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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