Leiomyoma, Uterine Clinical Trial
Official title:
Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial
Verified date | May 2024 |
Source | Acibadem University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.
Status | Completed |
Enrollment | 102 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study. Exclusion Criteria: 1. Patients who are planned to undergo different surgery along with myomectomy 2. Those with a diagnosis and suspicion of malignancy 3. Those with a history of thromboembolic disease 4. Those with cardiac, hepatic or renal disease 5. Those with a body mass index of 30 and above 6. Patients with abnormal coagulation test results 7. Patients using anticoagulants 8. Those who use drugs or diseases that may affect coagulation (serum creatinine > 1.5 mg/dL) 9. Those allergic to tranexamic acid |
Country | Name | City | State |
---|---|---|---|
Turkey | Acibadem Maslak Hospital | Istanbul | Sariyer |
Lead Sponsor | Collaborator |
---|---|
Acibadem University |
Turkey,
Buckley VA, Nesbitt-Hawes EM, Atkinson P, Won HR, Deans R, Burton A, Lyons SD, Abbott JA. Laparoscopic myomectomy: clinical outcomes and comparative evidence. J Minim Invasive Gynecol. 2015 Jan;22(1):11-25. doi: 10.1016/j.jmig.2014.08.007. Epub 2014 Aug 10. — View Citation
Jin C, Hu Y, Chen XC, Zheng FY, Lin F, Zhou K, Chen FD, Gu HZ. Laparoscopic versus open myomectomy--a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009 Jul;145(1):14-21. doi: 10.1016/j.ejogrb.2009.03.009. Epub 2009 Apr 23. — View Citation
Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5. — View Citation
LaMorte AI, Lalwani S, Diamond MP. Morbidity associated with abdominal myomectomy. Obstet Gynecol. 1993 Dec;82(6):897-900. — View Citation
Okolo S. Incidence, aetiology and epidemiology of uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2008 Aug;22(4):571-88. doi: 10.1016/j.bpobgyn.2008.04.002. Epub 2008 Jun 4. — View Citation
Opoku-Anane J, Vargas MV, Marfori CQ, Moawad G, Maasen MS, Robinson JK. Intraoperative tranexamic acid to decrease blood loss during myomectomy: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2020 Sep;223(3):413.e1-413.e7. doi: 10.1016/j.ajog.2020.02.019. Epub 2020 Mar 28. — View Citation
Srivastava S, Mahey R, Kachhawa G, Bhatla N, Upadhyay AD, Kriplani A. Comparison of intramyometrial vasopressin plus rectal misoprostol with intramyometrial vasopressin alone to decrease blood loss during laparoscopic myomectomy: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:279-283. doi: 10.1016/j.ejogrb.2018.07.006. Epub 2018 Jul 5. — View Citation
Winkler UH. The effect of tranexamic acid on the quality of life of women with heavy menstrual bleeding. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 1;99(2):238-43. doi: 10.1016/s0301-2115(01)00414-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perioperative blood loss | The amount of perioperative bleeding will be calculated by measuring the blood volume in the suction device and subtracting the irrigation fluid from the total amount. | At the end of the surgery. | |
Primary | Preoperative and postoperative hemoglobin change | Preoperative and postoperative hemoglobin values will be recorded. | On postoperative day 0 and day 2 | |
Secondary | Need for postoperative blood transfusion | Patients who received postoperative blood transfusions will be recorded. | Postoperative day 1 | |
Secondary | Operation time | Operation time will be recorded. | At the end of the operation. | |
Secondary | Postoperative thrombosis symptoms | Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month. | At postoperative first week and 3rd month. |
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