Methods Decreasing Bleeding in Open Myomectomy

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Arginine Vasopressin; Bupivacaine; Carbetocin; Epinephrine; Ethamsylate; Misoprostol; Oxytocin; Vasopressins

Criteria

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.