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In this study, the investigators will investigate the effectiveness of an intravenous tranexamic acid plus triple tourniquets compared with triple tourniquets alone for the reduction of blood loss at the time of myomectomy
An RCT investigated the efficacy of intravenous tranexamic acid (TA) during abdominal myomectomy. The study was unable to demonstrate any significant impact on blood loss, duration of surgery or need for blood transfusionHemostatic tourniquets to reduce intra-operative bleeding have long been available, but data on their efficacy from controlled trials are lacking. The investigators set out to evaluate the use of triple tourniquets plus tranexamic acid in controlled conditions and for the first time to investigate the hypothesis that adding tranexamic acid to tourniquet around the uterine artery reduces postoperative bleeding from the uterine incisions, a well-recognized sequel to surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple tourniquets plus TA | Active Comparator | A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus1-gram tranexamic acid (10 ml) in 100 ml saline infusion |
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| Triple tourniquets plus placebo to TA | Active Comparator | A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triple tourniquets | Procedure | A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels |
| Measure | Description | Time Frame |
|---|---|---|
| Mean amount of intraoperative blood loss | measure the mean amount of intraoperative blood loss by gravimetric methods | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients needs for blood transfusion | Calculation the number of patients needs for blood transfusion | 24 hours post delivery |
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Inclusion Criteria:
Exclusion Criteria:
All women who prepared for abdominal myomectomies will be invited to participate in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f sallam, md | Contact | 0102236052 | 002 | hany.farouk@aswu.edu.eg |
| nahla w shady, md | Contact | 01092440504 | 002 | nahla.elsayed@aswu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| hany f sallam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Recruiting | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D009214 | Myoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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A double-blinded randomized placebo-controlled trial
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A double-blinded randomized placebo-controlled trial
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| TA | Drug | 1-gram tranexamic acid (10 ml) in 100 ml saline infusion |
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| placebo to TA | Other | placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion |
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