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

Zagazig University

Status: Enrolling

Conditions: Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06566352

218/12-3-2024

Details and patient eligibility

About

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.

Full 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?

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Experimental group

Description:

laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Treatment:

Procedure: laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

Experimental group

Description:

Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

Treatment:

Procedure: Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

Drug: injection of epinephrine 1mg diluted in 200mg of NaCl

traditional laparoscopic myomectomy

Experimental group

Description:

traditional laparoscopic myomectomy

Treatment:

Procedure: traditional laparoscopic myomectomy