Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy (TESTO)

April 1, 2019 updated by: Taejong Song, Kangbuk Samsung Hospital

Temporary Simultaneous Two-arterial Occlusions to Reduce Operative Blood Loss During Laparoscopic Myomectomy: a Randomized Controlled Trial

The aim of this study was to evaluate the efficacy and safety of the temporary simultaneous two-arterial occlusions (TESTO) on operative blood loss during laparoscopic myomectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Significant hemorrhage is major perioperative concern in myomectomy, and can result in need of blood transfusion, conversion to hysterectomy, development of hypovolemic shock and postoperative anemia, and delayed recovery. Therefore, methods to decrease operative blood loss during myomectomy in women wishing to preserve their uterus and fertility are important and must be developed.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

19 years to 48 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with symptomatic myomas such as menorrhagia, pelvic pressure/pain, or infertility
  • women who were planning to undergo laparoscopic myomectomy
  • women who had ≤ 10 myomas, with the largest myoma ≤ 10 cm
  • women with regular menstrual bleeding
  • women who were not pregnant at the surgery
  • women between 19 and 48 years of age.

Exclusion Criteria:

  • women who underwent concomitant complex surgical procedures at the time of laparoscopic myomectomy, such as severe adhesiolysis or resection for severe endometriosis
  • women who were in postmenopausal or climacteric status
  • women with a history of oophorectomy or salpingo-oophorectomy
  • women with any suggestion of malignant uterine or adnexal diseases
  • women with major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance
  • women who refused to participate or give consent to the procedures

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LM with TESTO
In subjects allocated to the experimental group, the temporary simultaneous two-arterial occlusions (TESTO) procedure was performed to minimize operative blood loss during laparoscopic myomectomy.
Procedure: LM with TESTO
In subjects allocated to the experimental group, the temporary simultaneous two-arterial occlusions (TESTO) procedure was performed to minimize operative blood loss during laparoscopic myomectomy.
ACTIVE_COMPARATOR: LM without TESTO
In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy.
Procedure: LM without TESTO
In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative blood loss
Time Frame: the day of surgery
Operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery.
the day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in hemoglobin
Time Frame: post-operative day 1
The change in hemoglobin change was defined as the difference between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1.
post-operative day 1

Collaborators and Investigators

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

Sponsor

Kangbuk Samsung Hospital

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

May 1, 2016

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

September 1, 2018

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (ESTIMATE)

April 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-04-053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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