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Recruiting NCT06566352

Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy; A Randomized Controlled Clinical Trial

No phase Interventional Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine, traditional laparoscopic myomectomy, laparoscopic myomectomy with temporary bilateral uterine artery occlusion, injection of epinephrine 1mg diluted in 200mg of NaCl.
Who it may be relevant to
Registry conditions: Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy. Basic parameters: 18 years — 39 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation and hospitalization period after laparoscopic myomectomy.

Detailed description

Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation, and hospitalization period after laparoscopic myomectomy.

This will be the first study to investigate the efficacy of Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine in minimizing blood loss during Laparoscopic myomectomy at our university.

Can Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine give better outcomes regarding intraoperative bleeding when compared to traditional laparoscopic myomectomy?

Interventions

  • Procedure Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine
    intramyometrial injection of epinephrine 1mg diluted in 200mg of NaCl solution
  • Procedure traditional laparoscopic myomectomy
    traditional laparoscopic myomectomy
  • Procedure laparoscopic myomectomy with temporary bilateral uterine artery occlusion
    Experimental: laparoscopic myomectomy with temporary bilateral uterine artery occlusion
  • Drug injection of epinephrine 1mg diluted in 200mg of NaCl
    injection of epinephrine 1mg diluted in 200mg of NaCl

Primary outcome measures

  • blood loss [Time frame: intra-operative]

Eligibility criteria

Inclusion criteria

  • Women aged from 18 to 39 years.
  • Symptomatizing Women (heavy menstrual bleeding or subfertility).
  • FIGO stage (3-7) by ultrasound.
  • Only uterine corpus fibroid.
  • Up to three fibroids by ultrasound.
  • No previous hormonal treatment.

Exclusion criteria

  • Patients with bleeding tendency.
  • Patients who refuse to participate in the study or uncooperative patients.
  • Current pregnancy.
  • Any retroperitoneal surgery at pararectal space.
  • More than one cesarean delivery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Zagazig University — Zagazig

Identifiers

NCT: NCT06566352 · 218/12-3-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗