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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRHa | Experimental | 3,75 MG LEUPROLIDE ACETATE FOR EVERY 4 WEEKS THROUGHOUT 3 MONTHS BEFORE SURGERY |
|
| no GnRHa | Placebo Comparator | NO TREATMENT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS | Drug | THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MERAL TUĞBA ÇİMŞİR | Contact | 05064742272 | dr.tugbaacar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| MERAL TUĞBA ÇİMŞİR | ALKU EDUCATİON AND RESEARCH HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alku Alanya Education and Research Hospital | Antalya | Turkey (Türkiye) |
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5 YEARS
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PROSPECTİVE RANDOMİSED CONTROLLED TRİAL
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| NO GnRHa | Drug | THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS |
|
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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