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

August 21, 2024 updated by: Ahmed Nashat Fatah Allah Omran, Zagazig University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt, 7123001
        • Recruiting
        • Zagazig University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laparoscopic myomectomy with temporary bilateral uterine artery occlusion
Procedure: laparoscopic myomectomy with temporary bilateral uterine artery occlusion
Experimental: laparoscopic myomectomy with temporary bilateral uterine artery occlusion
Experimental: Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine
Procedure: Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine
intramyometrial injection of epinephrine 1mg diluted in 200mg of NaCl solution
Drug: injection of epinephrine 1mg diluted in 200mg of NaCl
injection of epinephrine 1mg diluted in 200mg of NaCl
Experimental: traditional laparoscopic myomectomy
Procedure: traditional laparoscopic myomectomy
traditional laparoscopic myomectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: intra-operative
estimated blood loss
intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 218/12-3-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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