Uterine Tourniquet at Open Myomectomy

Not Applicable

Completed

• Conditions: Myomectomy; Uterine Leiomyoma
• Interventions: Procedure: Single tourniquet; Procedure: triple tourniquet

• Registration Number: NCT02049242
• Lead Sponsor: Ataturk University

Brief Summary

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

Detailed Description

Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-21
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• uterine myoma >12 weeks

Exclusion Criteria

• Pedunculated myoma, broad ligament myoma
• Hb<10.5 g /dl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single tourniquet	Single tourniquet	-
Triple tourniquet	triple tourniquet	-

Primary Outcome Measures

Name	Time	Method
Estimating blood loss at the end of myomectomy	15 minutes postoperatifly	Surgical blood loss will be estimated by sum of the volume of suction fluid and blood loss quantitated by gravimetric method.; During surgery, if it is possible, irrigation will not be done, surgical sponge and compress will not be used.; * Suction fluid will be measured at the end of operation and volume of irrigation fluid will be subtracted from total suction volume.; * Surgical drapes, sponges and towels will be weighted before and just after surgery. The blood loss will be estimated as differences in gram by weighing when 1ml blood supposed as 1 gr.

Secondary Outcome Measures

Name	Time	Method
The amount of transfusions	7 Days	Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.
Anti-Mullerian Hormone levels variation	6 weeks	Anti-Mullerian Hormone levels before and 6 months after surgery
Volume in drains	7 days	Drain will be removed when discharge drops below 50 ml/day
A change in hemoglobin	At baseline and 48 hours after surgery

Trial Locations

Locations (1)

Atatürk Universitesi Araştırma Hastanesi; 🇹🇷 Erzurum, Yakutiye, Turkey