The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy

Overview

The uterine fibroids are the most common benign tumors found in the female reproductive system. Uterine fibroids commonly cause heavy menstrual periods. The prevalence of uterine fibroids is significantly affecting up to 70-80% of women by the age of 50, with an inconsistent impact on women of African origin. Carbitocin is a synthetic analogue of oxytocin which has a longer half-life than oxytocin. A Cochrane review and meta-analysis studies found that carbitocin reduced the use of additional uterotonics and transfusion. However, few of these studies was done during myomectomy.

INTRODUCTION The uterine fibroids - heavy bleeding during myomectomy. The prevalence - 70-80% of women by the age of 50. Common in black women. Cabetocin is a synthetic analogue of oxytocin, with a longer half-life than oxytocin. A Cochrane review and meta-analysis noted that cabetocin reduced the use of additional uterotonics and blood transfusion, with only few during myomectomy and results inconsistent Aim To determine the efficacy of cabetocin in reduction of blood loss during myomectomy. Specific Objectives To evaluate the impact of cabetocin on prevention of perioperative blood loss during myomectomy. To assess the transfusion rates, hospital stay, duration of surgery, cadre and years of practice of the surgeon. To determine if the FIGO stage (Munro, 2011) of the Myoma affect the cabetocin effect. To assess any intraoperative side effect. JUSTIFICATION Uterine fibroid - 20%-40% are symptomatic and contribute to subfertility Hysterectomy has been done for uncontrollable bleeding during myomectomy Hence, interventions to lessen bleeding during myomectomy and reduce the number of hysterectomy is vital. Cabetocin is widely recommendation in obstetrics but has limited use in gynaecology; hence the study STATEMENT OF PROBLEM Myomectomy is associated with significant blood loss and this causes adverse outcomes for patients. Many haemostatic agents during myomectomy have been explored However, none has given the desired result. Cabetocin though, promising in obstetrics practice is yet to be significantly proven in gynaecological practice like myomectomy METHODOLOGY Multicentre double-blind randomized placebo-controlled trial design It will be conducted in Ebonyi State across the three tertiary hospitals - (DUFUTH, AEFUTHA and NOFIC) Comprise women undergoing open abdominal myomectomy who fits into the eligibility criteria. Following Sample size determination = 300 participants per centre = 900 total participants. Ethical approvals and support letters from the three centers will be made available Informed consent will be secured from all participants prior to recruitment. Participants will be recruited from clinics and surgical outreaches. Randomization and concealment will be done by the pharmacist. Normal pre, intra and post op care will be observed as in open myomectomy with 22g tourniquet. Spinal-Epidural Anesthesia will be used Group A will receive 100μg intravenous cabetocin at induction of anesthesia Group B will receive intravenous placebo (normal saline). Blood loss estimation will follow the method described by Elousov et al. Preoperative HB done 12hours before the surgery Postoperative HB done 48hours after the surgery EBL(liters) = (EBV (Weight in kg x 65ml / 1000) X difference in HB (Hi-Hf) ) / Average HB (Hi-+ Hf) 2 FIGO STAGING OF MYOMA Type 0: Pedunculated intracavitary Type 1: \<50% intramural extension Type 2: ≥50% intramural extension Type 3: 100% intramural, contacting endometrium Type 4: 100% intramural, zero contact with either the endometrium or the outer serosal surface Type 5: Subserosal, ≥50% intramural Type 6: Subserosal, \<50% intramural Type 7: Pedunculated subserosal Type 8: Non-myometrial or ectopic PROFOMA SERIAL NUMBER:…………………………………….……………………………………………………………. (A) GENERAL CHARACTERISTICS 1. Age:………………………………………Parity:……….………….…………………………………………….. 2. Weight (kg): ........................................ Height (meters):......................................... 3. Blood group:…………………………….Rhesus Factor:…………………………………………………. (B) HAEMOGLOBIN ESTIMATION Pre Myomectomy HB:…………………………………………………………………………………………… Post Myomectomy HB:………………………………………………………………………………………….. (C). BLOOD TRANSFUSION RATE:…………………………………………………………………………… (D). DURATION OF HOSPITAL STAY: ............................................................................ (E). CADRE OF THE SURGEON:……………………………………………………………………………….. (F). DURATION OF SURGERY:………………………………………………………………………………….. (G). NOTICED INTRAOPERATIVE SIDE EFFECTS: ……………………………………………………… ……………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………… (H). FIGO STAGING OF THE MYOMA:…………………………………………………………………….. (I). DURATION OF SURGERY:………………………………………………………………………………….. (J). NUMBER OF YEARS OF PRACTICE OF THE SURGEON: ……………………………………… (K). PROFESSIONAL CADRE OF THE SURGEON:……………………………………………………… Data will be collected with a profoma and analyzed with SPSS v25. Continuous variables will be expressed as means ± 2SD, normal distributed data = Student's t-test, and non normal distributed data = Mann-Whitney U test. Categorical variables will be expressed in frequencies and percentages and compared with Chi-square tests. A p-value \< 0.05 will be considered significant.