Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy

Myoma Clinical Trial

— TESTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747550
• Other study ID #: 2016-04-053
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: September 2018

Study information

• Verified date: April 2019
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Myoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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