Authored by Ahmed M Abbas*
Abstract
Introduction: Uterine fibroids are benign tumours of the uterus. They represent the most common benign tumour of the female genital tract during reproductive period. The aim of this study was to decrease blood loss during myomectomy using carbetocin in comparison with tranexamic acid.
Material and Methods: In this randomized clinical trial, 132 patients with uterine fibroids were enrolled for our study at Gynaecology outpatient clinic, Suez Canal University Hospitals, from May 2016 to May 2018. Patients were assessed by full history, clinical examination, transvaginal ultrasound and laboratory investigations. After patients’ counselling and consent, they were randomly assigned into 2 groups (66 patients each); the first group received 30 ml of sodium chloride with added 50mg tranexamic acid, while the second group received 30 ml of sodium chloride with added 100 mg Carbetocin. Both drugs were delivered at the time of skin incision by intravenous infusion. The amount of blood loss was estimated intra-operatively and post-operatively and the collected data were statistically analysed.
Results: Total blood loss was significantly lower in the carbetocin group (399.27 ± 28.94ml) than the tranexamic acid group (535.15 ± 80.30ml) (p <0.001). Intra-operative blood loss was significantly lower in the carbetocin group (371.39 ± 27.54 ml) than the tranexamic acid group (478.48 ± 60.4ml) (p <0.001). Post-operative blood loss was significantly lower in the carbetocin group (27.88 ± 32.32 ml) than the tranexamic acid group (56.67 ± 53.13ml) (p 0.001).
Conclusion: Carbetocin is more effective than tranexamic acid on reduction of blood loss during abdominal myomectomy.
Keywords: Fibroids; Myomectomy; Blood loss; Tranexamic acid; Carbetocin
Introduction
Uterine leiomyomas represent the most common benign tumours encountered in women, originating from myometrium smooth muscle cells. These tumours are estrogen dependent and grow during the reproductive period with incidence of approximately 70% in the general population [1]. Approximately 20-40% of women with fibroids experience significant symptoms and consult gynecologic care. However, their true prevalence is probably under-estimated [2].
The standard approach for treating leiomyoma is hysterectomy for women who do not want to have more children and myomectomy for those who want to preserve fertility [3]. Bleeding during myomectomy is one of the major complications which can result in significant morbidity and mortality. Despite advances in reducing excessive haemorrhage during the procedure, it still remains a major challenge for gynecologic surgeons [4].
Several interventions have been developed to control bleeding during this operation such as dissection and embolization of uterine artery, use of mechanical tourniquets, use of uterotonic medications such as oxytocin, Carbetocin, ergometrine, misoprostol and manipulation of the coagulation cascade with antifibrinolytic treatment, especially aprotinin, tranexamic acid, epsilonaminocaproic acid, desmopressin and recombinant factor VIIa [5].
Tranexamic acid (TA), a synthetic lysine derivative with antifibrinolytic activity has been used since the 1960s in a variety of clinical settings where anti-fibrinolytic therapy is appropriate. It acts as an anti-fibrinolytic through the reversible blockade of lysine-binding sites on plasminogen molecules. It is an inhibitor of fibrinolysis. It has been routinely used for many years to reduce haemorrhage during and after surgical procedures. It has been shown to be very useful for reducing blood loss and blood transfusions [6].
Carbetocin is a synthetic long-acting oxytocin analogue. Its intravenous half-life is 85 to 100 min which is10 times longer than that of oxytocin. It has a rapid onset and long- lasting action. Carbetocin and uterine oxytocin receptors in the uterus caused rhythmic contraction, which can increase the frequency of existing contractions as well as uterine tone. During surgery, the uterine smooth muscles were made to contract, so that the tumour protrudes from the uterine surface and the level of the tumour cavity would be easy to find and peel [7].
There are no enough studies that compare the efficacy and safety of using intravenous tranexamic acid and intravenous Carbetocin for reduction of blood loss during myomectomy, therefore, this study aims to assess and compare between them for their ability to reduce blood loss during myomectomy.
Materials and Methods
This randomized clinical trial was carried out in the obstetrics and gynaecology department of Suez Canal University Hospital and included 132 female patients with uterine fibroids that necessitated abdominal myomectomy in the period from May 2016 to May 2018.
Inclusion criteria included patients with age ranging from 18 to 50 years with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within last 12 months, patients complaining of abnormal vaginal bleeding, chronic pelvic pain, pressure symptoms or reproductive disorders with pre-operative haemoglobin> 8g/ dl. Exclusion criteria included post-menopausal women together with patients previously treated with Depo-Lupron, Depo- Provera or oral contraceptive pills, patients with known bleeding/ clotting disorders, active liver, kidney or cardiovascular disease or receiving anticoagulant, NSAIDs or antiplatelet, previous history of gynecological malignancy, previous abdominal myomectomy or venous thromboembolism.
After approval to participate in the study by providing informed written consent, patients had been allocated to either group using Simple randomization by a randomization table created by a computer software program. A full history was taken included personal, menstrual, obstetrics, contraceptive, past and surgical histories. All patients had full clinical examination included general, abdominal and vaginal examinations. Laboratory investigations were done including haemoglobin, hematocrit, platelet count, prothrombin time and partial thromboplastin time. An abdominal or transvaginal ultrasound was done to assess the size, number, and location of myomas.
At the time of skin incision, the patients in the first group (n= 66) received 30 ml of sodium chloride with added 500mg tranexamic acid (Kapron 500 mg ampoule, Amoun pharmaceuticals) by intravenous infusion while cases in 2nd group (n=66) received 30 ml of sodium chloride with added 100 mcg Carbetocin (Pabal 100 mcg ampoule, Ferring Pharmaceuticals) also by intravenous infusion. The blood loss was assessed from the start of the operation till skin closure and also post-operative till the second post-operative day or till the removal of the drain. The weight of the dry surgical swabs (30g for each 30*30cm abdominal swabs) was measured before use and after being wet or soaked by blood. A highly accurate digital balance was used to measure the weight in grams. The weight difference was translated into the blood loss considering that 1g is equal to 1ml bl. The amount of intraoperative blood loss (ml) = (the weight of used towels–the weight of towels prior to surgery) + blood in suction apparatus. The amount of postoperative blood loss was assessed by the insertion of intraperitoneal tube drain and the calculation of amount of blood in the drain till the drain removed.
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