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Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy

NCT04996498 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

  • Leiomyoma

Interventions

DRUG

Oxytocin

intrauterine Instillation of oxytocin in distention media used during Hysteroscopic Myomectomy

OTHER

sterile bacteriostatic water ampule

a placebo drug similar in shape to oxytocin ampules

Sponsors & Collaborators

  • Ain Shams University

    collaborator OTHER

  • Ain Shams Maternity Hospital

    lead OTHER

Principal Investigators

  • amir Mahfouz, Master · AinShams MH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-07-01
Completion
2022-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04996498 on ClinicalTrials.gov