Blood Loss, Surgical Clinical Trial
Official title:
Comparing the Effectiveness of Misoprostol, Oxytocin, Carbetocin, Vasopressin, Bupivacaine and Epinephrine, Combined IV TXA Acid and Ethamsylate and Peri Cervical Tourniquet for the Reduction of Blood Loss During of Abdominal Myomectomy.
Uterine leiomyomas (fibroids or myomas) are benign, smooth muscle tumors of the human uterus. Most myomas are asymptomatic (symptomless) and are discovered incidentally during a routine pelvic examination or imaging studies and have a lifetime incidence of approximately 70% in the general population . However, Approximately 20-40% of women with fibroids experience significant symptoms and consult gynecologic care. The most common clinical symptoms include abnormal uterine bleeding, dysmenorrhea, pelvic pain, infertility, and recurrent pregnancy loss The standard treatment of symptomatic leiomyomas is Abdominal myomectomy Blood loss during myomectomy can be intra-operative or postoperative and with hematoma formation. The average volume of blood loss during abdominal myomectomy is 200 to 800 ml. massive blood loss associated with the dissection of huge fibroids renders myomectomy a more technically challenging procedure than hysterectomy. Sometimes myomectomy is converted to hysterectomy intra-operatively when bleeding becomes heavy and uncontrollable or when it is impossible to reconstruct the uterus because of the many defects left by removal of multiple myomas . Many techniques are used to reduce blood loss during myomectomy; preoperative measures such as correction of preoperative anemia associated with menorrhagia may be treated with iron supplementation, use of gonadotropin (GHG) triggers prior to surgery. Intra-operative measures as use of tourniquet around the uterus during the operation, injections of Vasopressin or other vasopressors as epinephrine in the uterine muscle and use of ecbolic (misoprostol, oxytocin, and carbetocin etc.). Uterine artery ligation, embolization, or internal iliac artery ligation may also be used to avoid hysterectomy when heavy bleeding is anticipated or occurs during myomectomy
Status | Recruiting |
Enrollment | 105 |
Est. completion date | November 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 48 Years |
Eligibility | Inclusion Criteria: 1. patients aged between 25 to 48 years old. 2. BMI less than 35 kg/m2 3. symptomatic uterine myomas.. 4. myoma staging from (3 to 6) according to FIGO staging through trans vaginal ultrasonography (TVUSG) or magnetic resonance imaging (MRI) according to FIGO classification. 5. Maximum diameter of the largest myoma is 15 cm. 6. Uterine size between 14 to 28 weeks pregnancy. Exclusion Criteria: 1. History of previous myomectomy 2. Allergy to Misoprostol, carbetocin, TXA, ethamsylate, Oxytocin, vasopressin, bupivacaine and epinephrine. 3. Hypertension. 4. Cardiac and Pulmonary diseases. 5. Patients who have bleeding disorders. 6. Patients on antiplatelets or anticoagulant before surgery. 7. Anemia (Hb < 10g %). 8. Chronic endocrine or metabolic diseases such as Diabetes. 9. Renal and hepatic impairment. 10. Obesity (body mass index > 30 kg/m2). 11. Cases that will require intraoperative conversion of myomectomy to hysterectomy. 12. Intracavitary, submucosal, pedunculated Subserosal and adnexal Myoma FIGO staging 0,1,2,7,8. 13. history of Gynecological infections (PID), history of abdominal infections e.g.: peritonitis, history of any abdominal or pelvic operation for non-obstetric cause. |
Country | Name | City | State |
---|---|---|---|
Egypt | faculty of medicine, Kasr el ainy hospital, Cairo university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Camanni M, Bonino L, Delpiano EM, Ferrero B, Migliaretti G, Deltetto F. Hysteroscopic management of large symptomatic submucous uterine myomas. J Minim Invasive Gynecol. 2010 Jan-Feb;17(1):59-65. doi: 10.1016/j.jmig.2009.10.013. — View Citation
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Donnez J, Dolmans MM. Uterine fibroid management: from the present to the future. Hum Reprod Update. 2016 Nov;22(6):665-686. doi: 10.1093/humupd/dmw023. Epub 2016 Jul 27. — View Citation
Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5. — View Citation
Krentel H, De Wilde RL. Complications in Laparoscopic Supracervical Hysterectomy(LASH), especially the morcellation related. Best Pract Res Clin Obstet Gynaecol. 2016 Aug;35:44-50. doi: 10.1016/j.bpobgyn.2015.11.001. Epub 2015 Nov 14. — View Citation
M Al-Morsi, A., N Abdul-Galeel, K., & A El-Desouky, E. S. (2021). Comparative study between oxytocin versus tranexamic acid and ethamsylate combination in reducing intraoperative blood loss in myomectomy. Al-Azhar Medical Journal, 50(3), 1893-1908.
Mohamed, S. E. S., Mansour, D. Y., & Shaker, A. N. (2019). The effect of misoprostol on intra-operative blood loss during myomectomy operation: Randomized controlled trial. Evidence Based Women's Health Journal, 9(1), 363-371.
Shady, N. W., Sallam, H. F., & Fahmy, H. (2018). Reducing blood loss during open myomectomy with intravenous versus topical tranexamic acid: A double-blinded randomized placebo-controlled trial. Middle East Fertility Society Journal, 23(3), 225-231.
Sirkeci RF, Belli AM, Manyonda IT. Treating symptomatic uterine fibroids with myomectomy: current practice and views of UK consultants. Gynecol Surg. 2017;14(1):11. doi: 10.1186/s10397-017-1014-4. Epub 2017 Jul 6. — View Citation
Sleiman Z, Baba RE, Garzon S, Khazaka A. The Significant Risk Factors of Intra-Operative Hemorrhage during Laparoscopic Myomectomy: A Systematic Review. Gynecol Minim Invasive Ther. 2019 Nov 11;9(1):6-12. doi: 10.4103/GMIT.GMIT_21_19. eCollection 2020 Jan-Mar. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blood loss | the estimated intra-operative blood loss in ml | 3 hours | |
Secondary | blood transfusion | Number of patients in each group who require transfusion and how many units they need | 24 hours | |
Secondary | Preoperative and postoperative hemoglobin values | will be measured in g/dl on 24 hours before and 24 hours after surgery | 48 hours | |
Secondary | Perioperative blood pressure | Measure blood presure in mmhg at start and end of operation and then every hour interval up to first four hours postoperative | 4-6 hours | |
Secondary | the duration of hospital stays | How many days patient stay in hospital after surgery for recovery | 3 day | |
Secondary | Operation time | measured from incision of first myoma to serosal closure of last myoma wound in minutes | 3 hours |
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