Overview

This trial is active, not recruiting.

Condition uterine myoma
Treatments single tourniquet, triple tourniquet
Sponsor Ragıp Atakan Al
Start date March 2015
End date March 2016
Trial size 60 participants
Trial identifier NCT02392585, ATAUNİ23

Summary

The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
single tourniquet
Single tourniquet is tourniquet applied uterine isthmus to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.
(Active Comparator)
triple tourniquet
Triple tourniquet consist of two tourniquet applied both infundibulopelvic ligaments and one uterine isthmus to occlude the left and right ovarian vessels and to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os. Through the same openings in the broad ligament each side a Foley catheter looped around the infundibulopelvic ligament lateral to the fallopian tube and ovary.

Primary Outcomes

Measure
Estimated blood loss at the end of myomectomy
time frame: 15 minutes postoperatively

Secondary Outcomes

Measure
The amount of transfusions
time frame: 7 Days
A change in hemoglobin
time frame: At baseline and 48 hours after surgery
Volume in drains
time frame: 7 days
Peri-operative complications
time frame: 6 weeks
Total operation time
time frame: 5 minutes post operatively
Tourniquet time
time frame: 5 minutes after tourniquet removed

Eligibility Criteria

Female participants from 18 years up to 48 years old.

Inclusion Criteria: 1. Three or more uterine myoma 2. At least one myoma ≥ 8 cm, if there is less than three myoma Exclusion Criteria: 1. Pedunculated myoma, 2. broad ligament myoma

Additional Information

Official title Triple Tourniquet vs. Single Tourniquet to Reduce Haemorrhage During Myomectomy: a Prospective Randomised Controlled Trial
Principal investigator Neset Gümüsburun, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Ataturk University.