Single or Triple Uterine Tourniquet at Myomectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02392585
• Date of registration: 13/03/2015
• Prospective Registration: No
• Primary sponsor: Ragip Atakan Al
• Public title: Single or Triple Uterine Tourniquet at Myomectomy
• Scientific title: Triple Tourniquet vs. Single Tourniquet to Reduce Haemorrhage During Myomectomy: a Prospective Randomised Controlled Trial
• Date of first enrolment: March 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02392585
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Turkey

Contacts

• Name: Neset Gümüsburun, MD
• Affiliation: Ataturk University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 48 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Uterine Myoma

Intervention(s)

Procedure: Single tourniquet

Procedure: Triple tourniquet

Primary Outcome(s)

Estimated blood loss at the end of myomectomy [Time Frame: 15 minutes postoperatively]

Secondary Outcome(s)

Peri-operative complications [Time Frame: 6 weeks]

Total operation time [Time Frame: 5 minutes post operatively]

A change in hemoglobin [Time Frame: At baseline and 48 hours after surgery]

Volume in drains [Time Frame: 7 days]

The amount of transfusions [Time Frame: 7 Days]

Tourniquet time [Time Frame: 5 minutes after tourniquet removed]

Secondary ID(s)

ATAUNI23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors