Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy

NCT02747550 | Completed

• 1 other identifier: 2016-04-053
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in hemoglobin

  post-operative day 1

Study Arms (2)

LM with TESTO

EXPERIMENTAL

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.

Procedure: LM with TESTO

LM without TESTO

ACTIVE COMPARATOR

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

Procedure: LM without TESTO

Interventions

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 with TESTO

LM without TESTO PROCEDURE

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

LM without TESTO

Eligibility Criteria

• Age: 19 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

MeSH Terms

Conditions

Myoma

Interventions

testo

Condition Hierarchy (Ancestors)

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

Study Officials

• Taejong Song, MD, PhD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)