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NCT Number: NCT06566352

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

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.

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Key information

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University

Zagazig, 7123001, Egypt

Location status: Recruiting

Location contact

Mohamed s ali, MD

CONTACT

[email protected]

01282112344

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

Procedure

intramyometrial injection of epinephrine 1mg diluted in 200mg of NaCl solution

traditional laparoscopic myomectomy

Procedure

traditional laparoscopic myomectomy

laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Procedure

Experimental: laparoscopic myomectomy with temporary bilateral uterine artery occlusion

injection of epinephrine 1mg diluted in 200mg of NaCl

Drug

injection of epinephrine 1mg diluted in 200mg of NaCl

Primary outcomes

  1. blood loss

    Time frame: intra-operative

    estimated blood loss

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.