Single or Triple Uterine Tourniquet at Myomectomy

Study Overview
=================
Brief Summary
-----------------
The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.

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

Conditions
-----------------
Uterine Myoma

Intervention / Treatment
-----------------
* Procedure: Single tourniquet
* Procedure: Triple tourniquet


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single tourniquet<br> | Procedure: Single tourniquet<br>* 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.<br>|
| Active Comparator: Triple tourniquet<br> | Procedure: Triple tourniquet<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leiomyoma of uterus, Hemostasis, Surgical, Prevention of Surgical Blood Loss, mechanical uterine tourniquet