Effects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trial
Abstract Background Strategies to preserve ovarian function after ovarian endometriotic cyst removal have been reported in many studies; however, no study has evaluated tranexamic acid administration during surgery. Objective To evaluate feasibility of conducting a definitive trial and assessing the...
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| Format: | Article |
| Language: | English |
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BMC
2021-09-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-021-00907-y |
| _version_ | 1819101972519714816 |
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| author | Prangthip Akkaranurakkul Srithean Lertvikool Woradej Hongsakorn Orawin Vallibhakara Siriluk Tantanavipas Krissada Paiwattananupant Wichai Ittichaikulthol Apirom Vongsakulyanon Sakda Arj-Ong Vallibhakara Makaramas Anantaburana Areepan Sophonsritsuk |
| author_facet | Prangthip Akkaranurakkul Srithean Lertvikool Woradej Hongsakorn Orawin Vallibhakara Siriluk Tantanavipas Krissada Paiwattananupant Wichai Ittichaikulthol Apirom Vongsakulyanon Sakda Arj-Ong Vallibhakara Makaramas Anantaburana Areepan Sophonsritsuk |
| author_sort | Prangthip Akkaranurakkul |
| collection | DOAJ |
| description | Abstract Background Strategies to preserve ovarian function after ovarian endometriotic cyst removal have been reported in many studies; however, no study has evaluated tranexamic acid administration during surgery. Objective To evaluate feasibility of conducting a definitive trial and assessing the potential efficacy of tranexamic acid on ovarian reserve and intra-operative blood loss by comparing mean differences in anti-Müllerian hormone (AMH) levels following laparoscopic ovarian cystectomy between tranexamic acid and control groups. Materials and methods A parallel two-arm pilot trial was conducted with 40 participants with endometriotic cysts who underwent laparoscopic ovarian cystectomy. They were randomized 1:1 to either 1 g tranexamic acid (TXA) or no TXA (n = 20 per group). TXA was administered to the participants immediately after induction of general anesthesia and intubation. The primary outcome was the feasibility of conducting a definitive trial in terms of design and procedures (such as recruitment rate, retention, safety of intravenous 1 gm of TXA, sample size verification) and assess the efficacy of TXA on the ovarian reserve and intra-operative blood loss by comparing mean difference of AMH levels between TXA and control groups at pre- and 3 months post-surgery. Results The recruitment and successful completion rates were 95% and 100%. Baseline characteristics were similar in the two groups. The mean difference of serum AMH levels (pre- and 3 months post-surgery) between the TXA and control groups was not significantly different. When performing a subgroup analysis, the mean difference of AMH levels (pre- and 3 months post-surgery) seemed to be higher in the bilateral than in the unilateral ovarian cyst group but not significantly different. Operating time was significantly longer in bilateral than in unilateral cysts. No post-operative complications or adverse effects were found. Conclusion The full randomized controlled trial for evaluating effects of TXA administration during laparoscopic cystectomy for endometrioma on ovarian reserve was shown to be feasible. Several modifications should be added for improving feasibility, for example, increasing the TXA dose, modifying TXA administration, focusing on either patients with unilateral or bilateral ovarian cysts, and exploring other outcome measures, e.g., surgeons’ satisfaction. Trial registration Thai Clinical Trials Registry, TCTR20190424002 , Registered 24 April 2019. |
| first_indexed | 2024-12-22T01:27:10Z |
| format | Article |
| id | doaj.art-9af70c75f83e4adf93d3a4aedb9965c6 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-12-22T01:27:10Z |
| publishDate | 2021-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-9af70c75f83e4adf93d3a4aedb9965c62022-12-21T18:43:35ZengBMCPilot and Feasibility Studies2055-57842021-09-017111010.1186/s40814-021-00907-yEffects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trialPrangthip Akkaranurakkul0Srithean Lertvikool1Woradej Hongsakorn2Orawin Vallibhakara3Siriluk Tantanavipas4Krissada Paiwattananupant5Wichai Ittichaikulthol6Apirom Vongsakulyanon7Sakda Arj-Ong Vallibhakara8Makaramas Anantaburana9Areepan Sophonsritsuk10Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol UniversityReproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathidodi Hospital, Mahidol UniversityReproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathidodi Hospital, Mahidol UniversityReproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathidodi Hospital, Mahidol UniversityReproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathidodi Hospital, Mahidol UniversityGynecologic Oncology Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathidodi Hospital, Mahidol UniversityDepartment of Anesthesiology, Faculty of Medicine Ramathidodi Hospital, Mahidol UniversityDepartment of Pathology, Faculty of Medicine Ramathibodi Hospital, Mahidol UniversityASEAN Institute for Health Development, Mahidol UniversityReproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathidodi Hospital, Mahidol UniversityReproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Ramathidodi Hospital, Mahidol UniversityAbstract Background Strategies to preserve ovarian function after ovarian endometriotic cyst removal have been reported in many studies; however, no study has evaluated tranexamic acid administration during surgery. Objective To evaluate feasibility of conducting a definitive trial and assessing the potential efficacy of tranexamic acid on ovarian reserve and intra-operative blood loss by comparing mean differences in anti-Müllerian hormone (AMH) levels following laparoscopic ovarian cystectomy between tranexamic acid and control groups. Materials and methods A parallel two-arm pilot trial was conducted with 40 participants with endometriotic cysts who underwent laparoscopic ovarian cystectomy. They were randomized 1:1 to either 1 g tranexamic acid (TXA) or no TXA (n = 20 per group). TXA was administered to the participants immediately after induction of general anesthesia and intubation. The primary outcome was the feasibility of conducting a definitive trial in terms of design and procedures (such as recruitment rate, retention, safety of intravenous 1 gm of TXA, sample size verification) and assess the efficacy of TXA on the ovarian reserve and intra-operative blood loss by comparing mean difference of AMH levels between TXA and control groups at pre- and 3 months post-surgery. Results The recruitment and successful completion rates were 95% and 100%. Baseline characteristics were similar in the two groups. The mean difference of serum AMH levels (pre- and 3 months post-surgery) between the TXA and control groups was not significantly different. When performing a subgroup analysis, the mean difference of AMH levels (pre- and 3 months post-surgery) seemed to be higher in the bilateral than in the unilateral ovarian cyst group but not significantly different. Operating time was significantly longer in bilateral than in unilateral cysts. No post-operative complications or adverse effects were found. Conclusion The full randomized controlled trial for evaluating effects of TXA administration during laparoscopic cystectomy for endometrioma on ovarian reserve was shown to be feasible. Several modifications should be added for improving feasibility, for example, increasing the TXA dose, modifying TXA administration, focusing on either patients with unilateral or bilateral ovarian cysts, and exploring other outcome measures, e.g., surgeons’ satisfaction. Trial registration Thai Clinical Trials Registry, TCTR20190424002 , Registered 24 April 2019.https://doi.org/10.1186/s40814-021-00907-yAnti-fibrinolytic AgentsAnti-Mullerian hormoneEndometriosisOvarian reserveTranexamic acid |
| spellingShingle | Prangthip Akkaranurakkul Srithean Lertvikool Woradej Hongsakorn Orawin Vallibhakara Siriluk Tantanavipas Krissada Paiwattananupant Wichai Ittichaikulthol Apirom Vongsakulyanon Sakda Arj-Ong Vallibhakara Makaramas Anantaburana Areepan Sophonsritsuk Effects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trial Pilot and Feasibility Studies Anti-fibrinolytic Agents Anti-Mullerian hormone Endometriosis Ovarian reserve Tranexamic acid |
| title | Effects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trial |
| title_full | Effects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trial |
| title_fullStr | Effects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trial |
| title_full_unstemmed | Effects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trial |
| title_short | Effects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trial |
| title_sort | effects of intravenous tranexamic acid on ovarian reserve and intra operative blood loss during laparoscopic cystectomy of endometriotic cyst a pilot randomized controlled trial |
| topic | Anti-fibrinolytic Agents Anti-Mullerian hormone Endometriosis Ovarian reserve Tranexamic acid |
| url | https://doi.org/10.1186/s40814-021-00907-y |
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