Myoma
Conditions
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.
Interventions
PROCEDURELM 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.
PROCEDURELM without TESTO
In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed