Myoma Clinical Trial
— TESTOOfficial title:
Temporary Simultaneous Two-arterial Occlusions to Reduce Operative Blood Loss During Laparoscopic Myomectomy: a Randomized Controlled Trial
NCT number | NCT02747550 |
Other study ID # | 2016-04-053 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | September 2018 |
Verified date | April 2019 |
Source | Kangbuk Samsung Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years to 48 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kangbuk Samsung Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kangbuk Samsung Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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