Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy

NCT ID: NCT02747550

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-09-30

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.

Conditions

Myoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

LM with TESTO

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

LM without TESTO

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

LM without TESTO

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taejong Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taejong Song, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

Kangbuk Samsung Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2016-04-053

Identifier Type: -

Identifier Source: org_study_id