Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.

NCT05517590 | Completed

• 1 other identifier: ATADEK-2022/05-33
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.

Conditions

Leiomyoma, Uterine; Intraoperative Blood Loss

Keywords

Leiomyoma; Laparoscopic myomectomy; Tranexamic acid; Blood loss; İntramyometrial desmopressin

Outcome Measures

Primary Outcomes (2)

• 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.

• Preoperative and postoperative hemoglobin change

  Preoperative and postoperative hemoglobin values will be recorded.

  On postoperative day 0 and day 2

Secondary Outcomes (3)

• Need for postoperative blood transfusion

  Postoperative day 1

• Operation time

  At the end of the operation.

• Postoperative thrombosis symptoms

  At postoperative first week and 3rd month.

Study Arms (2)

Tranexamic acid and group (Group I)

ACTIVE COMPARATOR

In Group I, 1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Drug: Tranexamic acid

Saline group (Group II)

PLACEBO COMPARATOR

Group II placebo will be administered to the control group, and 100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Drug: Saline

Interventions

Tranexamic acid DRUG

1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Also known as: Group I

Tranexamic acid and group (Group I)

Saline DRUG

100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Also known as: Group II

Saline group (Group II)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study.

You may not qualify if:

• Patients who are planned to undergo different surgery along with myomectomy
• Those with a diagnosis and suspicion of malignancy
• Those with a history of thromboembolic disease
• Those with cardiac, hepatic or renal disease
• Those with a body mass index of 30 and above
• Patients with abnormal coagulation test results
• Patients using anticoagulants
• Those who use drugs or diseases that may affect coagulation (serum creatinine \> 1.5 mg/dL)
• Those allergic to tranexamic acid

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 18534913 BACKGROUND

• 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.

  PMID: 25117840 BACKGROUND

• 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.

  PMID: 19398260 BACKGROUND

• LaMorte AI, Lalwani S, Diamond MP. Morbidity associated with abdominal myomectomy. Obstet Gynecol. 1993 Dec;82(6):897-900.

  PMID: 8233261 BACKGROUND

• 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.

  PMID: 25125317 BACKGROUND

• 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.

  PMID: 32229194 BACKGROUND

• 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.

  PMID: 30056355 BACKGROUND

• 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.

  PMID: 11788179 BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mete Gungor

  Acıbadem Mehmet Ali Aydınlar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patient, the surgeon and the assistant that will collect the data will be masked about the patient's study group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective randomized

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 26, 2022
• Study Start: September 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)