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Uterine Tourniquet at Open Myomectomy

Primary Purpose

Myomectomy, Uterine Leiomyoma

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
triple tourniquet
Single tourniquet
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myomectomy focused on measuring Hemorrhage, Leiomyoma, Myofibroma, Uterine Myomectomy, Tourniquet

Eligibility Criteria

16 Years - 48 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • uterine myoma >12 weeks

Exclusion Criteria:

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

Sites / Locations

  • Atatürk Universitesi Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Triple tourniquet

Single tourniquet

Arm Description

Outcomes

Primary Outcome Measures

Estimating 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. 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

The amount of transfusions
Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.
A change in hemoglobin
Volume in drains
Drain will be removed when discharge drops below 50 ml/day
Anti-Mullerian Hormone levels variation
Anti-Mullerian Hormone levels before and 6 months after surgery

Full Information

First Posted
January 28, 2014
Last Updated
December 21, 2014
Sponsor
Ataturk University
Collaborators
Erzurum Nenehatun Kadın Doğum Hastanesi
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1. Study Identification

Unique Protocol Identification Number
NCT02049242
Brief Title
Uterine Tourniquet at Open Myomectomy
Official Title
Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
Collaborators
Erzurum Nenehatun Kadın Doğum Hastanesi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myomectomy, Uterine Leiomyoma
Keywords
Hemorrhage, Leiomyoma, Myofibroma, Uterine Myomectomy, Tourniquet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triple tourniquet
Arm Type
Active Comparator
Arm Title
Single tourniquet
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
triple tourniquet
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Single tourniquet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Estimating blood loss at the end of myomectomy
Description
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.
Time Frame
15 minutes postoperatifly
Secondary Outcome Measure Information:
Title
The amount of transfusions
Description
Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.
Time Frame
7 Days
Title
A change in hemoglobin
Time Frame
At baseline and 48 hours after surgery
Title
Volume in drains
Description
Drain will be removed when discharge drops below 50 ml/day
Time Frame
7 days
Title
Anti-Mullerian Hormone levels variation
Description
Anti-Mullerian Hormone levels before and 6 months after surgery
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Peri-operative complications
Description
Including but not limited to fever, pelvic infections, wound infections.
Time Frame
6 weeks postoperatively
Title
Total operation time
Time Frame
5 minutes post operatively
Title
Tourniquet time
Time Frame
5 minutes after tourniquet removed

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: uterine myoma >12 weeks Exclusion Criteria: Pedunculated myoma, broad ligament myoma Hb<10.5 g /dl
Facility Information:
Facility Name
Atatürk Universitesi Araştırma Hastanesi
City
Erzurum
State/Province
Yakutiye
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

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Uterine Tourniquet at Open Myomectomy

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