Reducing Operative Blood Loss in Laparoscopic Myomectomy With Umbilico-uterine Trunk Clipping

NCT ID: NCT07200778

Last Updated: 2025-10-07

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-11

Study Completion Date

2026-03-11

Brief Summary

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the purpose of this study is to examine how Umbilico-uterine trunk occlusion reduces surgery-associated blood loss in Laparoscopic Myomectomy.

Detailed Description

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Conditions

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Laparoscopic Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

participants will undergo umbilico-uterine trunk occlusion

Group Type EXPERIMENTAL

umbilico-uterine trunk occlusion

Intervention Type PROCEDURE

participants will undergo umbilico-uterine trunk occlusion during laparoscopic myomectomy

Group B

participants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision

Group Type ACTIVE_COMPARATOR

local epinephrine infiltration

Intervention Type PROCEDURE

participants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision during laparoscopic myomectomy

Interventions

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umbilico-uterine trunk occlusion

participants will undergo umbilico-uterine trunk occlusion during laparoscopic myomectomy

Intervention Type PROCEDURE

local epinephrine infiltration

participants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision during laparoscopic myomectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 19 and 45
* Symptoms of menorrhagia, pelvic pain, or infertility
* Plan to have a laparoscopic myomectomy
* Number of myomas ≤ 4, with the largest myoma measuring ≤ 9 cm

Exclusion Criteria

* Postmenopausal status
* Dominant pedunculated subserosal FIGO classification (6-7)
* Submucosal type of myoma FIGO classification (0-2)
* Suspicion of malignant uterine or adnexal diseases
* Major medical comorbidities or psychiatric illnesses that could affect follow-up and/or compliance
* Refusal to participate or provide consent to the procedures.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Hassan Mohamed Abdel Ghfar

Lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia advanced laparoscopy unit

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed abdelghfar, Lecturer

Role: CONTACT

+20 10 61624335

Facility Contacts

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Mohamed abdelghfar, Lecturer

Role: primary

+20 10 61624335

Other Identifiers

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1531-5-2025

Identifier Type: -

Identifier Source: org_study_id

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