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

Primary Purpose

Myoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LM with TESTO
LM without TESTO
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myoma

Eligibility Criteria

19 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kangbuk Samsung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LM with TESTO

LM without TESTO

Arm Description

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.

In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy.

Outcomes

Primary Outcome Measures

operative blood loss
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.

Secondary Outcome Measures

change in hemoglobin
The change in hemoglobin change was defined as the difference between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1.

Full Information

First Posted
April 19, 2016
Last Updated
April 1, 2019
Sponsor
Kangbuk Samsung Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02747550
Brief Title
Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy
Acronym
TESTO
Official Title
Temporary Simultaneous Two-arterial Occlusions to Reduce Operative Blood Loss During Laparoscopic Myomectomy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LM with TESTO
Arm Type
Experimental
Arm Description
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.
Arm Title
LM without TESTO
Arm Type
Active Comparator
Arm Description
In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy.
Intervention Type
Procedure
Intervention Name(s)
LM with TESTO
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
LM without TESTO
Intervention Description
In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy
Primary Outcome Measure Information:
Title
operative blood loss
Description
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.
Time Frame
the day of surgery
Secondary Outcome Measure Information:
Title
change in hemoglobin
Description
The change in hemoglobin change was defined as the difference between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1.
Time Frame
post-operative day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taejong Song, MD, PhD
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy

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