Myomectomy, Uterine Leiomyoma
Conditions
Keywords
Hemorrhage, Leiomyoma, Myofibroma, Uterine Myomectomy, Tourniquet
Brief summary
The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.
Detailed description
Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.
Interventions
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.
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.
Sponsors
Erzurum Nenehatun Kadın Doğum Hastanesi
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
* uterine myoma \>12 weeks
Exclusion criteria
* Pedunculated myoma, broad ligament myoma * Hb\<10.5 g /dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimating blood loss at the end of myomectomy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A change in hemoglobin | At baseline and 48 hours after surgery | — |
| The amount of transfusions | 7 Days | Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL. |
| Volume in drains | 7 days | Drain will be removed when discharge drops below 50 ml/day |
| Anti-Mullerian Hormone levels variation | 6 weeks | Anti-Mullerian Hormone levels before and 6 months after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tourniquet time | 5 minutes after tourniquet removed | — |
| Total operation time | 5 minutes post operatively | — |
| Peri-operative complications | 6 weeks postoperatively | Including but not limited to fever, pelvic infections, wound infections. |
Countries
Turkey (Türkiye)
Outcome results
None listed