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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-05-01

Brief Summary

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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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Detailed Description

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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?

Conditions

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Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Group Type EXPERIMENTAL

laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Intervention Type PROCEDURE

Experimental: laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

Group Type EXPERIMENTAL

Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

Intervention Type PROCEDURE

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

injection of epinephrine 1mg diluted in 200mg of NaCl

Intervention Type DRUG

injection of epinephrine 1mg diluted in 200mg of NaCl

traditional laparoscopic myomectomy

Group Type EXPERIMENTAL

traditional laparoscopic myomectomy

Intervention Type PROCEDURE

traditional laparoscopic myomectomy

Interventions

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Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

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

Intervention Type PROCEDURE

traditional laparoscopic myomectomy

Intervention Type PROCEDURE

laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Experimental: laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Intervention Type PROCEDURE

injection of epinephrine 1mg diluted in 200mg of NaCl

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No