Single or Triple Uterine Tourniquet at Myomectomy

Not Applicable

Completed

• Conditions: Uterine Myoma
• Interventions: Procedure: Single tourniquet; Procedure: Triple tourniquet

• Registration Number: NCT02392585
• Lead Sponsor: Ragıp Atakan Al

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-19
• Primary Completion: 2016-03
• Study Completion: 2017-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-09
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

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
Estimated blood loss at the end of myomectomy	15 minutes postoperatively	Surgical blood loss will be estimated by sum of the volume of suction fluid and blood loss quantitated by gravimetric method.; 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 1.06 gr.

Secondary Outcome Measures

Name	Time	Method
A change in hemoglobin	At baseline and 48 hours after surgery
Total operation time	5 minutes post operatively	Skin to skin operation time
Tourniquet time	5 minutes after tourniquet removed
Peri-operative complications	6 weeks	Including but not limited to fever, pelvic infections, wound infections.
The amount of transfusions	7 Days	Erythrocyte transfusions will be allowed when haemoglobin dropped below 8 g/dL.
Volume in drains	7 days	Drain will be removed when discharge drops below 50 ml/day

Trial Locations

Locations (1)

Atatürk Üniversitesi Araştırma Hastanesi; 🇹🇷 Erzurum, Turkey