Ain shams university maternity hospital
Cairo, Abbasia, 11517, Egypt
NCT Number: NCT04996498
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.
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Notify MeUp to 50 year
Female
Interventional
Not applicable
Cairo, Abbasia, 11517, Egypt
Patients will be subjected to:
Surgical procedure:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intrauterine Instillation of oxytocin in distention media used during Hysteroscopic Myomectomy
Other names: syntocinon
a placebo drug similar in shape to oxytocin ampules
Time frame: preoperative and 24 hour postoperative
the change of hemoglobin postoperative to know the effect of oxytocin compared to placebo in reducing blood loss.
surgery compared to the pre-operative values to see if intrauterine instillation of oxytocin will reduce blood loss during hysteroscopic myomectomy
Time frame: preoperative and 24 hour postoperative
a follow up CBC is done 24 hour after the procedure to see the difference in hematocrit and know about the blood loss intraoperative
Time frame: immediately postoperative
After completing the procedure, the surgeon will complete a record scale to document estimated blood loss, rating the bleeding (0: no bleeding, I; mild bleeding, II: moderate bleeding, III: severe bleeding, IV: severe bleeding with clots).
Time frame: immediately postoperative
Success of hysteroscopic myomectomy depends on good visualization throughout the procedure, so, if oxytocin decrease blood loss intraoperative , the operation time will be reduced .
Time frame: intraoperative and within the first 24 hours postoperative
there are some operative complications as uterine perforation , cervical tear and fluid overload also, there is some adverse effects of oxytocin as arrythmia, nausea, vomiting , hypotension and abdominal pain
Time frame: immediately postoperative
After completing the procedure, the surgeon will document the clarity of visual field using 3 point scale as (poor, fair, good)
Time frame: immediately postoperative
glycine 1,5% is used as a distention media during procedure, each solution contain 1000 ml . counting the number of solution used intraoperative to calculate the amount of distension media used.
Ain Shams Maternity Hospital
Other
Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy: A Randomized Double Blinded Control Trial
Acronym: oxytocin
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