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Effect and safety of diluted vasopressin injection on bleeding during robot-assisted laparoscopic myomectomy: a protocol for a randomised controlled pilot trial.
Lee, Eun Ji; Park, Soo Jin; Kim, Yup; Lim, Hyunji; Lee, Seungmee; Yim, Ga Won; Song, Gwonhwa; Kim, Hee Seung.
Afiliación
  • Lee EJ; Department of Obstetrics and Gynecology, Chung-Ang University Hospital, Seoul, Korea (the Republic of).
  • Park SJ; Department of Obstetrcis and Gynecology, Seoul National University Hospital, Seoul, Korea (the Republic of).
  • Kim Y; Department of Obstetrcis and Gynecology, Seoul National University Hospital, Seoul, Korea (the Republic of).
  • Lim H; Department of Obstetrcis and Gynecology, Seoul National University Hospital, Seoul, Korea (the Republic of).
  • Lee S; Department of Obstetrics and Gynecology, Keimyung University School of Medicine, Daegu, Korea (the Republic of).
  • Yim GW; Department of Obstetrics and Gynecology, Dongguk University College of Medicine, Goyang, Korea (the Republic of).
  • Song G; Institute of Animal Molecular Biotechnology and Department of Biotechnology, Korea University, Seoul, Korea (the Republic of).
  • Kim HS; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea (the Republic of) bboddi0311@snu.ac.kr.
BMJ Open ; 12(9): e056145, 2022 09 17.
Article en En | MEDLINE | ID: mdl-36115677
INTRODUCTION: Even though the injection of diluted vasopressin into the uterus is expected to reduce intraoperative bleeding with decreased adverse effects during robot-assisted laparoscopic myomectomy (RALM), there is a lack of relevant trials to show its effect and safety. Thus, this study was designed to compare the effect and safety of vasopressin injection on bleedings based on dilution levels of vasopressin with constant volumes during RALM. METHODS AND ANALYSIS: This is a randomised controlled pilot trial, where a total of 39 patients will be randomly divided into three experimental groups in a 1:1:1 ratio. All patients will be classified into the three groups based on the dilution level of vasopressin: group 1-a solution prepared by mixing 20 units of vasopressin with 100 mL of normal saline to make a total of 100 mL; group 2-a solution prepared by mixing 20 units of vasopressin with 200 mL of normal saline to make a total of 100 mL and group 3-a solution prepared by mixing 20 units of vasopressin with 400 mL of normal saline to make a total of 100 mL. During RALM, we will inject diluted vasopressin at different concentrations with a total of 100 mL. As the primary endpoint, estimated blood loss would be compared. As secondary endpoints, we will check the level of haemoglobin and haematocrit, operation time, amount of transfusion, and the period of hospitalisation. In addition, we will check other complications related to vasopressin injection. ETHICS AND DISSEMINATION: This pilot study has been approved by the Institutional Review Board of the Seoul National University Hospital (No. H-2011-107-1174). All potential subjects will be provided written informed consent. The results of this study will be published in peer-reviewed journals and be presented at academic conferences. TRIAL REGISTRATION NUMBERS: NCT04874246 and CKCT0006225.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Robótica / Laparoscopía / Miomectomía Uterina Tipo de estudio: Clinical_trials Aspecto: Ethics Límite: Female / Humans Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Robótica / Laparoscopía / Miomectomía Uterina Tipo de estudio: Clinical_trials Aspecto: Ethics Límite: Female / Humans Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido