Banghyun Lee1, Kidong Kim1, Hye Yon Cho2, Eun Joo Yang3, Dong Hoon Suh1, Jae Hong No1, Jung Ryeol Lee1, Jung Won Hwang4, Sang Hwan Do4, Yong Beom Kim5. 1. Department of Obstetrics and Gynecology, Seoul National University, Bundang Hospital, Seongnam-Si, Gyeonggi-Do, Republic of Korea. 2. Department of Obstetrics and Gynecology, Hallym University, Dongtan Sacred Heart Hospital, Hwaseong-Si, Gyeonggi-do, Republic of Korea. 3. Rehabilitation Medicine Department, Seoul National University, Bundang Hospital, Seongnam-Si, Gyeonggi-Do, Republic of Korea. 4. Department of Anesthesiology and Pain Medicine, Seoul National University, Bundang Hospital, Seongnam-Si, Gyeonggi-Do, Republic of Korea. 5. Department of Obstetrics and Gynecology, Seoul National University, Bundang Hospital, Seongnam-Si, Gyeonggi-Do, Republic of Korea; Seoul National University, School of Medicine, Seoul, Republic of Korea. Electronic address: ybkimlh@snubh.org.
Abstract
OBJECTIVE: Most interventions aimed at reducing bleeding during myomectomy lack sufficient evidence regarding their effectiveness. Recently, it was reported that intraoperative ascorbic acid administration effectively reduced blood loss during abdominal myomectomy. Therefore, this study aimed to investigate whether intravenous ascorbic acid infusion would affect intraoperative blood loss in women undergoing laparoscopic myomectomy. STUDY DESIGN: A randomized, double-blind, parallel-group, placebo-controlled trial including 50 women undergoing laparoscopic myomectomy was conducted. Women with ≤4 myomas, ≤9cm in maximum diameter were eligible. The study:control group ratio was 1:1. Starting 30minutes before anesthesia, 2g of ascorbic acid or a placebo were administered for 2hours intraoperatively. Intraoperative blood loss, the primary endpoint, was calculated as the difference between the volume of fluids acquired from suction and that used for irrigation of the abdominal cavity during surgery using constant values. RESULTS: Among the 50 randomized women, 1 and 3 in the study and control groups, respectively, were excluded due to withdrawal of consent, cancelation of surgery, or non-measurement of the primary endpoint. The baseline and operative characteristics were similar between the study and control groups, as was the intraoperative blood loss (193±204mL vs. 159±193mL, P=0.52). In addition, the operating time (95±29min vs. 110±52min; P=0.50) and decrease in hemoglobin level after surgery (1.9±1.31g/dL vs. 1.4±1.4g/dL; P=0.24) were similar between the study and control groups. CONCLUSIONS:Intravenous ascorbic acid infusion did not reduce intraoperative blood loss in women undergoing laparoscopic myomectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01715597.
RCT Entities:
OBJECTIVE: Most interventions aimed at reducing bleeding during myomectomy lack sufficient evidence regarding their effectiveness. Recently, it was reported that intraoperative ascorbic acid administration effectively reduced blood loss during abdominal myomectomy. Therefore, this study aimed to investigate whether intravenous ascorbic acid infusion would affect intraoperative blood loss in women undergoing laparoscopic myomectomy. STUDY DESIGN: A randomized, double-blind, parallel-group, placebo-controlled trial including 50 women undergoing laparoscopic myomectomy was conducted. Women with ≤4 myomas, ≤9cm in maximum diameter were eligible. The study:control group ratio was 1:1. Starting 30minutes before anesthesia, 2g of ascorbic acid or a placebo were administered for 2hours intraoperatively. Intraoperative blood loss, the primary endpoint, was calculated as the difference between the volume of fluids acquired from suction and that used for irrigation of the abdominal cavity during surgery using constant values. RESULTS: Among the 50 randomized women, 1 and 3 in the study and control groups, respectively, were excluded due to withdrawal of consent, cancelation of surgery, or non-measurement of the primary endpoint. The baseline and operative characteristics were similar between the study and control groups, as was the intraoperative blood loss (193±204mL vs. 159±193mL, P=0.52). In addition, the operating time (95±29min vs. 110±52min; P=0.50) and decrease in hemoglobin level after surgery (1.9±1.31g/dL vs. 1.4±1.4g/dL; P=0.24) were similar between the study and control groups. CONCLUSIONS: Intravenous ascorbic acid infusion did not reduce intraoperative blood loss in women undergoing laparoscopic myomectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01715597.