- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02049242
Uterine Tourniquet at Open Myomectomy
Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yakutiye
-
Erzurum, Yakutiye, Turkey, 25240
- Atatürk Üniversitesi Araştırma Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- uterine myoma >12 weeks
Exclusion Criteria:
- Pedunculated myoma, broad ligament myoma
- Hb<10.5 g /dl
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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 |
---|---|---|
Estimating blood loss at the end of myomectomy
Time Frame: 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.
|
15 minutes postoperatifly
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A change in hemoglobin
Time Frame: At baseline and 48 hours after surgery
|
At baseline and 48 hours after surgery
|
|
Volume in drains
Time Frame: 7 days
|
Drain will be removed when discharge drops below 50 ml/day
|
7 days
|
The amount of transfusions
Time Frame: 7 Days
|
Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.
|
7 Days
|
Anti-Mullerian Hormone levels variation
Time Frame: 6 weeks
|
Anti-Mullerian Hormone levels before and 6 months after surgery
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tourniquet time
Time Frame: 5 minutes after tourniquet removed
|
5 minutes after tourniquet removed
|
|
Peri-operative complications
Time Frame: 6 weeks postoperatively
|
Including but not limited to fever, pelvic infections, wound infections.
|
6 weeks postoperatively
|
Total operation time
Time Frame: 5 minutes post operatively
|
5 minutes post operatively
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- atauni10
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