Single or Triple Uterine Tourniquet at Myomectomy

Triple Tourniquet vs. Single Tourniquet to Reduce Haemorrhage During Myomectomy: a Prospective Randomised Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Uterine Myoma
• Intervention / Treatment: Procedure: Single tourniquet; Procedure: Triple tourniquet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25240
    • Atatürk Üniversitesi Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single tourniquet	Procedure: 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	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss at the end of myomectomy	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.	15 minutes postoperatively

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-Mullerian Hormone levels variation	Anti-Mullerian Hormone levels before surgery, 6 months and 12 months after surgery	One year postoperatively

Collaborators and Investigators

• Sponsor: Ragıp Atakan Al
• Investigators: Principal Investigator: Neset Gümüsburun, MD, Ataturk University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 9, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Leiomyoma of uterus; Hemostasis, Surgical; Prevention of Surgical Blood Loss; mechanical uterine tourniquet
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: ATAUNİ23