Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy (TESTO)

K

Kangbuk Samsung Hospital

Status

Completed

Conditions

Myoma

Treatments

Procedure: LM without TESTO
Procedure: LM with TESTO

Study type

Interventional

Funder types

Other

Identifiers

NCT02747550
2016-04-053

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

19 to 48 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

LM with TESTO
Experimental group
Description:
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.
Treatment:
Procedure: LM with TESTO
LM without TESTO
Active Comparator group
Description:
In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy.
Treatment:
Procedure: LM without TESTO

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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