search
Back to results

Single or Triple Uterine Tourniquet at Myomectomy

Primary Purpose

Uterine Myoma

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Single tourniquet
Triple tourniquet
Sponsored by
Ragıp Atakan Al
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Myoma focused on measuring Leiomyoma of uterus, Hemostasis, Surgical, Prevention of Surgical Blood Loss, mechanical uterine tourniquet

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Atatürk Üniversitesi Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single tourniquet

Triple tourniquet

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The amount of transfusions
Erythrocyte transfusions 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
Peri-operative complications
Including but not limited to fever, pelvic infections, wound infections.
Total operation time
Skin to skin operation time
Tourniquet time

Full Information

First Posted
March 13, 2015
Last Updated
February 9, 2019
Sponsor
Ragıp Atakan Al
search

1. Study Identification

Unique Protocol Identification Number
NCT02392585
Brief Title
Single or Triple Uterine Tourniquet at Myomectomy
Official Title
Triple Tourniquet vs. Single Tourniquet to Reduce Haemorrhage During Myomectomy: a Prospective Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ragıp Atakan Al

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myoma
Keywords
Leiomyoma of uterus, Hemostasis, Surgical, Prevention of Surgical Blood Loss, mechanical uterine tourniquet

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Single tourniquet
Arm Type
Active Comparator
Arm Title
Triple tourniquet
Arm Type
Active Comparator
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.
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.
Primary Outcome Measure Information:
Title
Estimated 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. 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.
Time Frame
15 minutes postoperatively
Secondary Outcome Measure Information:
Title
The amount of transfusions
Description
Erythrocyte transfusions 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
Peri-operative complications
Description
Including but not limited to fever, pelvic infections, wound infections.
Time Frame
6 weeks
Title
Total operation time
Description
Skin to skin operation time
Time Frame
5 minutes post operatively
Title
Tourniquet time
Time Frame
5 minutes after tourniquet removed
Other Pre-specified Outcome Measures:
Title
Anti-Mullerian Hormone levels variation
Description
Anti-Mullerian Hormone levels before surgery, 6 months and 12 months after surgery
Time Frame
One year postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Three or more uterine myoma At least one myoma ≥ 8 cm, if there is less than three myoma Exclusion Criteria: Pedunculated myoma, broad ligament myoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neset Gümüsburun, MD
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atatürk Üniversitesi Araştırma Hastanesi
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Single or Triple Uterine Tourniquet at Myomectomy

We'll reach out to this number within 24 hrs