Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

There is no previous study on the hemostatic effect of intrauterine instillation of oxytocin in hysteroscopic myomectomy. All previous studies focused on intravenous administration of oxytocin.

This trial may modify the surgical environment in hysteroscopic myomectomy by decreasing intraoperative bleeding to a degree that the amount of distention medium required for uterine distention will be reduced with a better visibility and shorter operation time.

The standard treatment of symptomatic myomas is hysterectomy for women who have completed childbearing period, and myomectomy for women who wish to preserve fertility hysteroscopic myomectomy currently is the gold standard minimally invasive procedure for the management of symptomatic submucous fibroids. Success of hysteroscopic myomectomy depends on good visualization throughout the procedure, via the correct distending pressure, continuous irrigation and the use of electrosurgery to control bleeding. Prolonged procedures that need continuous irrigation under high pressure are associated with higher risk of excessive fluid absorption and intravasation syndrome due to opened blood vessels within the myometrial, moreover, the thermal damage of the healthy tissues is increased with the use of the coagulation current.

Oxytocin receptors exist in the non-pregnant uterus but the concentration of the receptors is much lower than in pregnancy. this is why the clinical use of oxytocin outside of pregnancy is limited Oxytocin acts on oxytocin receptors in the myometrium and fibroid tissue leading to uterine contraction and constriction of uterine vasculature due to uterine contraction and vaso-constrictive effect of oxytocin thus reducing uterine perfusion and results in reducing intraoperative bleeding.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ain Shams Maternity Hospital
• Collaborator: Ain Shams University
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

1. Symptomatic patient (Menorrhagia, recurrent pregnancy loss or infertility).

2. 1 or 2 submucous uterine myoma diagnosed by ultrasound with a diameter less than 4 cm

3. Myoma with FIGO 0 or 1.

4. Body mass index less than 35.

Exclusion Criteria:

1. Pregnancy

2. Active pelvic infection

3. history of bleeding disorder or patient on anti-coagulant.

4. hepatic and renal diseases.

5. history of ischemic heart disease.

6. Patients with uterine structural abnormality or uterine septum.

7. Present or history of cervical or uterine cancer.

8. Preoperative administration of gonadotropin-releasing hormone analogues or danazol.

9. Allergy to glycine.

10. Patients with hypercoagulopathy.