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Completed

NCT Number: NCT02747550

Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy

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.

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Key information

Conditions

Myoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

19 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LM with TESTO

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

Procedure

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

Primary outcomes

  1. operative blood loss

    Time frame: 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 outcomes

  1. change in hemoglobin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Acronym: TESTO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2016
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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