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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04192812
Recruitment Status : Not yet recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
MERAL TUĞBA ÇİMŞİR, Alkü Alanya Education and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroid Gonadotropin-Releasing Hormone-Dependent Precocious Puberty Drug: PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS Drug: NO GnRHa Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: PROSPECTİVE RANDOMİSED CONTROLLED TRİAL
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: THE EFFICACY OF PREOPERATIVE USAGE OF GONADOTROPINE-RELEASING HORMONE AGONIST IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
Estimated Study Start Date : December 30, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 30, 2021


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




Primary Outcome Measures :
  1. AMOUNT OF BLEEDİNG [ Time Frame: 0 minute - 180 minute ]
    WHOLE AMOUNT OF BLEEDING DURING SURGERY

  2. DURATION AF SURGERY [ Time Frame: 0 MINUTE- 180 MINUTE ]
    TIME BETWEEN INITIAL AND END OF SURGERY



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • MYOMA UTERI
  • APPROPİATE FOR LAPAROSCOPY

Exclusion Criteria:

  • MALİGNANCY

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192812


Contacts
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Contact: MERAL TUĞBA ÇİMŞİR 05064742272 dr.tugbaacar@gmail.com

Locations
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Turkey
Alku Alanya Education and Research Hospital Not yet recruiting
Antalya, Turkey
Contact: MERAL TUĞBA ÇİMŞİR    05064742272    DR.TUGBAACAR@GMAİL.COM   
Sponsors and Collaborators
Alkü Alanya Education and Research Hospital
Investigators
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Principal Investigator: MERAL TUĞBA ÇİMŞİR ALKU EDUCATİON AND RESEARCH HOSPITAL

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Responsible Party: MERAL TUĞBA ÇİMŞİR, ASSOCIATE PROFESSOR, Alkü Alanya Education and Research Hospital
ClinicalTrials.gov Identifier: NCT04192812    
Other Study ID Numbers: ALKU RESEARCH HOSPİTAL
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 5 YEARS

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Puberty, Precocious
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Gonadal Disorders
Endocrine System Diseases
Leuprolide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents