Temporary Uterine Tourniquet Application Versus Local Myometrial Epinephrine Injection During Laparoscopic Myomectomy

April 6, 2026 updated by: Mohamed Hassan Mohamed Abdel Ghfar, Minia University
While both local vasoconstrictors and tourniquet application are recognized methods for blood loss control, there is a paucity of head-to-head randomized controlled trials directly comparing these two distinct approaches in laparoscopic myomectomy. Existing data often compare these methods to no intervention or to other less common techniques. A direct comparison is essential to determine which method offers superior hemostasis with an acceptable safety profile in the laparoscopic setting. This study aims to address this gap in the literature.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Not Applicable

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:

  • Female patients aged 18-45 years.
  • Diagnosed with symptomatic uterine leiomyomas requiring laparoscopic myomectomy.
  • Presence of at least one myoma with a diameter ≥3 cm and ≤10 cm.
  • Patients with up to 3 myomas (to standardize surgical complexity).
  • Preoperative hemoglobin level ≥10 g/dL.
  • Ability to provide informed consent.

Exclusion Criteria:

  • Patients with more than 3 myomas or any myoma larger than 10 cm.
  • Patients with suspected uterine malignancy (e.g., leiomyosarcoma).
  • Patients with known bleeding disorders or on anticoagulant therapy that cannot be safely discontinued.
  • Patients with significant cardiovascular disease, uncontrolled hypertension, or arrhythmias (relative contraindications for epinephrine).
  • Patients with active pelvic infection.
  • Patients with previous extensive uterine surgery (e.g., multiple prior myomectomies or extensive uterine reconstruction) that may compromise uterine integrity.
  • Patients undergoing concurrent major gynecological procedures that might significantly affect blood loss (e.g., hysterectomy, extensive adhesiolysis).
  • Patients with known allergy to epinephrine.
  • Patients unwilling or unable to comply with follow-up protocols.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Temporary Uterine Tourniquet Application
Procedure: Temporary Uterine Tourniquet Application
The tourniquet will be tightened just enough to achieve visible blanching of the uterus, indicating adequate vascular occlusion, but without excessive tension to avoid tissue damage
Active Comparator: Local Myometrial Epinephrine Injection
Procedure: Local Myometrial Epinephrine Injection
Approximately 5-10 mL of the diluted epinephrine will be injected into the myometrium surrounding each fibroid, specifically at the base of the myoma and along the planned incision line, using a laparoscopic injection needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative Blood Loss
Time Frame: During operation
During operation

Collaborators and Investigators

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

Sponsor

Minia 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 (Estimated)

April 20, 2026

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

January 20, 2027

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1706-9-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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