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.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- blood loss
研究概览
简要总结
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
详细描述
The aim of study:
The aim of the study is to compare the effectiveness of a single preoperative dose of rectal misoprostol, intramyometrial oxytocin, intramyometrial carbetocin, combined iv TXA acid and ethamsylate and peri cervical tourniquet for the reduction of blood loss during of abdominal myomectomy.
Methodology:
Type of Study: Prospective randomized comparative clinical trial Study Setting: This study will be conducted in Cairo University, kasr al-ainy hospitals, Maternity hospital in operative theater.
Study Period: 6 months from April 2023 to October 2023. Study Population: Patients will be recruited in this study from those attending gynecology ward at Kasr al-ainy hospitals, Maternity hospital who are 25-48 years old with symptomatic uterine myoma indicating operative management, abnormal uterine bleeding or bulk-related symptoms, females with infertility or recurrent pregnancy loss, pressure symptoms, and large myoma(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients aged between 25 to 48 years old.
- •BMI less than 35 kg/m2
- •symptomatic uterine myomas..
- •myoma staging from (3 to 6) according to FIGO staging through trans vaginal ultrasonography (TVUSG) or magnetic resonance imaging (MRI) according to FIGO classification.
- •Maximum diameter of the largest myoma is 15 cm.
- •Uterine size between 14 to 28 weeks pregnancy.
排除标准
- •History of previous myomectomy
- •Allergy to Misoprostol, carbetocin, TXA, ethamsylate, Oxytocin, vasopressin, bupivacaine and epinephrine.
- •Hypertension.
- •Cardiac and Pulmonary diseases.
- •Patients who have bleeding disorders.
- •Patients on antiplatelets or anticoagulant before surgery.
- •Anemia (Hb < 10g %).
- •Chronic endocrine or metabolic diseases such as Diabetes.
- •Renal and hepatic impairment.
- •Obesity (body mass index > 30 kg/m2).
- •Cases that will require intraoperative conversion of myomectomy to hysterectomy.
- •Intracavitary, submucosal, pedunculated Subserosal and adnexal Myoma FIGO staging 0,1,2,7,
- •history of Gynecological infections (PID), history of abdominal infections e.g.: peritonitis, history of any abdominal or pelvic operation for non-obstetric cause.
研究组 & 干预措施
misoprostol
15 patients will receive 800 microgram (tablet 200mcg X 4) misoprostol (Misotac 200 mcg, SIGMA pharmaceutical, Egypt) rectally one and half hour before operation.
干预措施: Misoprostol (Drug)
Tourniquet
(15 patient): The operation will be performed with the use of Foleys catheter as an improvised tourniquet applied at the base of the uterus then infiltration myometrium overlying the leiomyoma with a solution composed of Bupivacaine Hcl 0.25% and 0.5 mg of epinephrine
干预措施: Tourniquet (Device)
Carbetocin
intramural; preparation of 100 μg of carbetocin ((Pabal, Ampoule 100 mcg in 1 ml, Carbetocin; FERRING, North York, Canada) diluted within 10 cm of saline (0.9%) in sterile syringe then will inject the substance into the multiple sites intramyometrial in a circumferential manner 1-2 cm away from the margins of the myoma in the planned uterine-incision site just before uterine incision for myoma extraction.
干预措施: Carbetocin (Drug)
Oxytocin
15 patients): who will receive oxytocin 40 I.U. intramyometrially (Syntocinon, Ampule 10 I.U. in 1 ml, Oxytocin; NOVARTIS, Basel, Switzerland) then will inject the substance into the multiple sites intramyometrial in a circumferential manner 1-2 cm away from the margins of the myoma in the planned uterine-incision site just before uterine incision for myoma extraction.
干预措施: Oxytocin (Drug)
combined TXA and ethamsylate
(Patient 15): will receive 1 g tranexamic acid (2 ampoules of kapron 500 mg, kapron®, Amoun, Egypt) and 500 mg ethamsylate (2 ampoule of ethamsylate 250 mg, Dicynone, OM pharma, Geneva, Switzerland) IV 10 minutes before skin incision by slowly intravenous injection Then infusion was applied continuously for 24 hours within 1 liter of saline as 1 mg/kg/hour.
干预措施: combined TXA and ethamsylate (Drug)
vasopressin
15 women will receive terlipressin (Glypressin, Ferring, Egypt) intramyometrial injection of one ampoule of vasopressin containing 20 units in1 ml after dilution in 19 ml of normal saline during myomectomy.
干预措施: Vasopressin (Drug)
bupivacaine and epinephrine
15 women in which the operation will be performed after infiltration of the serosa and / or myometrium overlying the leiomyoma before uterine incision with a solution composed of 50 ml Bupivacaine Hcl 0.25% (Bucain® Weimer pharma, for Actavis Group PTC) and 0.5 mg of epinephrine Hcl (2 vials of Epinephrine® 0.25mg/1ml Misr Co. for Pharmaceutical Industries).
干预措施: Bupivacaine Hydrochloride 0.5 % Injectable Solution epinephrine (Drug)
结局指标
主要结局
blood loss
时间窗: 3 hours
the estimated intra-operative blood loss in ml
次要结局
- blood transfusion(24 hours)
- Preoperative and postoperative hemoglobin values(48 hours)
- Perioperative blood pressure(4-6 hours)
- the duration of hospital stays(3 day)
- Operation time(3 hours)
研究者
ahmed nagy shaker ramadan
lecturer
Cairo University