Intrauterine Instillation of Tranexamic Acid in Hysteroscopic Myomectomy: A Double-Blind,Placebo-Controlled,Parallel-Group Randomized Clinical Trial |
| |
| Affiliation: | 1. Department of Minimally Invasive Gynecologic Surgery, Brigham and Women''s Hospital, Boston Massachusetts. (Drs. Pepin, Dmello, Sandberg, Hill-Verrochi, Ajao, Cohen, Einarsson, and Ms. Maghsoudlou);2. Leiden University Medical Centre, Leiden, The Netherlands, (Dr. Sandberg);3. Baystate Medical Center, Springfield, Massachusetts (Dr. Hill-Verochi);4. The Mayo Clinic, Rochester, Minnesota (Dr. Cohen).;1. Department of Women’s Health Services, Henry Ford Health System, Detroit MI;2. Virginia Mason Medical Center, Seattle WA;3. Department of Public Health Services, Henry Ford Health System, Detroit MI |
| |
| Abstract: | Study ObjectiveTo evaluate the hemostatic effect of intrauterine instillation of tranexamic acid (TXA) with the distention medium during hysteroscopic myomectomy.DesignProspective, parallel-group, double-blind, placebo-controlled randomized clinical trial.SettingEarly Cancer Detection Unit in Ain Shams University Maternity Hospital, Cairo, Egypt.PatientsEighty women with type 0 or I submucous myoma undergoing hysteroscopic myomectomy using unipolar resectoscope.InterventionsThe participants were randomly assigned to receive either 1 g of TXA for every 1000 mL of the distending medium (intervention group) or 10 mL of placebo (10 mL of 1.5% glycine) in the same form inside every 1000 mL of the distention medium.Measurements and Main ResultsThe primary outcome was a change in hemoglobin level 24 hours after surgery compared with preoperative values, and the secondary outcomes were the surgeon's rating of intraoperative bleeding and the quality of operative view, the duration of surgery, the volume of injected media, intraoperative complications, and the completion of myomectomy in 1 procedure. The mean difference in hemoglobin level was 1.11 ±.58 g/dL in the TXA group and 1.46 ± 0.61 g/dL in the placebo group (p = .015). The quality of hysteroscopic view was better in the TXA group (p = .001), with good operative view in 23 (60.5%) cases in TXA vs 8 (20.5%) in the placebo group. The surgeon's rating of bleeding as excessive was reported in 1 (2.6%) case in the TXA group and in 9 (23.1%) cases in the placebo group. There was no difference between the groups regarding the duration of surgery, the volume of injected media, completion of myoma resection in 1 session, and intraoperative complications. Three cases of uterine perforation with the thermal loop were reported, and all were associated with poor operative field in the placebo group.ConclusionIntrauterine instillation of TXA with the distention medium during hysteroscopic myomectomy resulted in a statistically significant decrease in hemoglobin level 24 hours after surgery, albeit with minimal clinical significance. TXA resulted in better visualization of the field throughout the procedure. |
| |
| Keywords: | |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
