TESTO: Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy

Sponsor

Kangbuk Samsung Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02747550

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myoma	Procedure: LM with TESTO Procedure: LM without TESTO	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

operative blood loss [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.

Secondary Outcome Measures

change in hemoglobin [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 48 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kangbuk Samsung Hospital	Seoul		Korea, Republic of	110-746

Sponsors and Collaborators

Kangbuk Samsung Hospital

Investigators

Principal Investigator: Taejong Song, MD, PhD, Kangbuk Samsung Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taejong Song, Professor, Kangbuk Samsung Hospital

ClinicalTrials.gov Identifier:

NCT02747550

Other Study ID Numbers:

2016-04-053

First Posted:

Apr 21, 2016

Last Update Posted:

Apr 2, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Apr 2, 2019