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

Not Applicable

Recruiting

• Conditions: Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy
• Interventions: Procedure: laparoscopic myomectomy with temporary bilateral uterine artery occlusion; Procedure: Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine; Procedure: traditional laparoscopic myomectomy; Drug: injection of epinephrine 1mg diluted in 200mg of NaCl

• Registration Number: NCT06566352
• Lead Sponsor: Zagazig University

Brief Summary

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?

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic myomectomy with temporary bilateral uterine artery occlusion	laparoscopic myomectomy with temporary bilateral uterine artery occlusion	laparoscopic myomectomy with temporary bilateral uterine artery occlusion
Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine	Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine	Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine
Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine	injection of epinephrine 1mg diluted in 200mg of NaCl	Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine
traditional laparoscopic myomectomy	traditional laparoscopic myomectomy	traditional laparoscopic myomectomy

Primary Outcome Measures

Name	Time	Method
blood loss	intra-operative	estimated blood loss

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt