Efficacy and safety of pre-operative vaginal misoprostol in reduction of intraoperative blood loss during myomectomy; a multicentre double blind controlled trial.

Abstract

Despite advances in minimal access surgery and interventional radiological techniques, open myomectomy remains the principal treatment for multiple large uterine fibroids especially when preservation of fertility is desired. The predilections towards conservative surgical approaches have to be balanced against potential risks such as hemorrhage; blood loss at open myomectomy remains dreary with the use of various pharmacologic agents yielding inconclusive results Hypothesis: There is no difference in mean blood loss during open myomectomy whether one preoperatively inserts a single dose of 400mcg vaginal Misoprostol or not. Methods: We carried out a double blind randomized multicenter clinical trial at Mulago National Referral and Lacor hospitals. 48 women with symptomatic fibroids were randomly assigned into either the control (standard of care) or Misoprostol arm by using computer-generated random numbers. Enrollment and allocation were done on gynecological wards. Surgeons and research assistants in theatre were blinded. The Primary endpoint was blood loss as estimated by surgical mops and suction while the secondary endpoints were length of hospital stay, postoperative hemoglobin and rate of blood transfusion. Data was analyzed on an intention-to-treat basis using STATA software 14.0. The means, medians, standard deviations and interquartile range were used to summarize the data. Categorical data was summarized using frequencies, proportions and percentages. The student’s t-test was used assess for statistical difference in mean blood loss. The Fishers exact, chi square, and Mann Whitney U test were used to compare the various characteristics between the two groups We carried out multiple linear regression to assess the effect of age, parity, presence of side effects, total fibroid mass and usage of other intraoperative blood-loss techniques on the mean blood loss. Results: Mean age and the mean preoperative and postoperative Hb levels were not significantly different between the two groups. Mean duration of surgery and mean estimated blood loss were also comparable in both arms. 13/24 (54.2 %) patients in control group needed blood transfusion while 4/23 (17.4%) of those in misoprostol group needed transfusion (p = 0.015). Conclusion: a single preoperative dose of misoprostol was found to be safe although no benefit in reduction of intra-operative blood loss during myomectomy was observed.