Uterine Tourniquet at Open Myomectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02049242|
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : December 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Myomectomy Uterine Leiomyoma||Procedure: triple tourniquet Procedure: Single tourniquet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|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.
|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.
- 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.
- 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.
- The amount of transfusions [ Time Frame: 7 Days ]Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.
- A change in hemoglobin [ Time Frame: 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
- Anti-Mullerian Hormone levels variation [ Time Frame: 6 weeks ]Anti-Mullerian Hormone levels before and 6 months after surgery
- Peri-operative complications [ Time Frame: 6 weeks postoperatively ]Including but not limited to fever, pelvic infections, wound infections.
- Total operation time [ Time Frame: 5 minutes post operatively ]
- Tourniquet time [ Time Frame: 5 minutes after tourniquet removed ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049242
|Atatürk Universitesi Araştırma Hastanesi|
|Erzurum, Yakutiye, Turkey, 25240|