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To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients
To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients undergoing surgery, radiation therapy, and chemotherapy, and to establish a patient blood management program and introduce it as a standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient blood management group | Experimental |
|
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| conventional management group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose 50Mg/Ml Inj 20Ml | Drug | ferric carboxymaltose 1000mg, fixed dose for intervention group |
|
| Measure | Description | Time Frame |
|---|---|---|
| transfusion rate | Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment | within 3 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| hemoglobin differences | Comparison of hemoglobin differences between the groups | within 3 weeks after surgery |
| Frequency of anemia | Frequency of anemia and blood transfusion before adjuvant therapy between the groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeong-Yeol Park, M.D., Ph.D | Contact | +821074748988 | catgut1-0@hanmail.net | |
| Ok Ju Kang, M.D. | Contact | 82-10-2320-5499 | lalala1301@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeong-Yeol Park | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37094968 | Derived | Park JY, Kang OJ, Lee YY, Kim YS. A prospective randomized controlled trial evaluating the safety and efficacy of patient blood management program in patients with gynecologic cancer (KGOG 4011/PBM). Int J Gynecol Cancer. 2023 Jul 3;33(7):1140-1144. doi: 10.1136/ijgc-2023-004403. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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| RBC | Drug | pack RBC transfusion |
|
| within 3 weeks after surgery |
| Frequency and delay period of treatment | Frequency and delay period of treatment delay due to anemia before adjuvant therapy between the groups | within 3 weeks after surgery |
| The costs that patients actually pay for treatment (Cost-effectiveness) | Investigate, evaluate, and compare the costs that patients actually pay for treatment between the two groups. | within 3 weeks after surgery |
| Quality of life of patients EORTC QLQ-C30 | used to collect information on patients' quality of life and compare the scores of the two groups. Scores are given from 1 to 4 for most questions, and the lower the score, the better the patient's quality of life is evaluated. The average of the total scores is used to compare the two groups. | within 3 weeks after surgery |
| Adverse events | ADR (adverse drug reaction) is investigated between the two groups, and the rate of adverse reactions and the rate of moderate adverse reactions in each group are compared. | within 3 weeks after surgery |
| Quality of life of patients HINT-8 | HINT-8 used to collect information on patients' quality of life and compare the scores of the two groups. Each answer is given to 8 questions, and each answer is scored and assigned from 1 to 4 points, and the averages of the two groups are also compared. | within 3 weeks after surgery |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002577 | Uterine Cervical Diseases |