Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myoma

Intervention / Treatment
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* Procedure: LM with TESTO
* Procedure: LM without TESTO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LM with TESTO<br>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<br>* 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.<br>|
| Active Comparator: LM without TESTO<br>In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy. | Procedure: LM without TESTO<br>* In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | the day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | post-operative day 1 |