Uterine Myoma
Conditions
Keywords
Leiomyoma of uterus, Hemostasis, Surgical, Prevention of Surgical Blood Loss, mechanical uterine tourniquet
Brief summary
The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.
Interventions
PROCEDURESingle 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.
PROCEDURETriple 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.
Sponsors
Ragıp Atakan Al
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated blood loss at the end of myomectomy | 15 minutes postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| The amount of transfusions | 7 Days | Erythrocyte transfusions will be allowed when haemoglobin dropped below 8 g/dL. |
| A change in hemoglobin | At baseline and 48 hours after surgery | — |
| Volume in drains | 7 days | Drain will be removed when discharge drops below 50 ml/day |
| Total operation time | 5 minutes post operatively | Skin to skin operation time |
| Tourniquet time | 5 minutes after tourniquet removed | — |
| Peri-operative complications | 6 weeks | Including but not limited to fever, pelvic infections, wound infections. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anti-Mullerian Hormone levels variation | One year postoperatively | Anti-Mullerian Hormone levels before surgery, 6 months and 12 months after surgery |
Countries
Turkey (Türkiye)
Outcome results
None listed