Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy

Not Applicable

Completed

• Conditions: Myoma
• Interventions: Procedure: LM with TESTO; Procedure: LM without TESTO

• Registration Number: NCT02747550
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-21
• Study Start: 2016-05
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LM with TESTO	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.
LM without TESTO	LM without TESTO	In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of