Abstract
Purpose
This study aimed to compare the effect of triple uterine tourniquet and single tourniquet on intraoperative blood loss during open myomectomy.
Methods
Women were randomized to undergo open myomectomy with a triple (n = 30) or single uterine tourniquet (n = 30). All symptomatic women aged 18–48 who had three or more myomas or at least one myoma greater than 8 cm if there were less than three myomas were eligible for the study. The primary outcome variable was the volume of intraoperative blood loss. The sample size was set to detect a 240 ml difference in blood loss with 80% power at α = 0.05, with an effect size of 0.8. The rate of transfusions, change in hemoglobin, volume of drains, operation time, tourniquet time, and perioperative complications were secondary outcomes.
Results
We found no significant difference in intraoperative blood loss between triple and single uterine tourniquets (527 [102–2931]) ml vs. 508 [172–2764] ml, p = 0.238). Between the single and triple tourniquet groups, the median weight of myoma (379 [136–3850] vs. 330 [140–1636] g, p = 0.451) and median number (1 [1–18] vs. 2 (1–13), p = 0.214), total operation time (84 ± 31 min vs. 79 ± 27 min, p = 0.503), ischemia time (35 ± 21 min vs. 30 ± 14 min., p = 0.238), drain volume at 48th hour (196 ± 89)ml vs. 243 ± 148 ml, p = 0.144) and decrease in hemoglobin (2.3 ± 1.8 g/dl vs. 2.8 ± 1.4 g/dl, p = 0.437) were similar. Eight (27%) patients in the triple tourniquet group and 12 (40%) patients in the single tourniquet group were transfused (p = 0.273). One patient underwent hysterectomy 6–8 h after myomectomy in a single tourniquet group.
Conclusion
There was no clinically significant difference in intraoperative blood loss between triple and single uterine tourniquets during open myomectomy.
Clinical Trial Registration Number and date of registration
ClinicalTrials.gov ID: NCT02392585, 03/13/2015.
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Data availability
No data available.
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NG, OEY, and RAA contributed to the study conception, design, material preparation, data collection, and analysis. The manuscript was written by RAA and SO. All authors read and approved the final manuscript.
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The authors have no relevant financial or non-financial interests to disclose.
Ethical approval
This study was performed in line with the principles of the Declaration of Helsinki. This study was approved by the Clinical Research Ethics Committee of the Faculty of Medicine of Ataturk University (Date 05.03.2015/No B.30.2.ATA.0.01.00/45).
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Informed consent was obtained from all the participants included in the study.
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Gümüsburun, N., Yapca, O.E., Ozdes, S. et al. Triple vs. single uterine tourniquet to reduce hemorrhage at myomectomy: a randomized trial. Arch Gynecol Obstet 308, 1811–1816 (2023). https://doi.org/10.1007/s00404-023-07201-7
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DOI: https://doi.org/10.1007/s00404-023-07201-7