Uterine Tourniquet at Open Myomectomy

Uterine Leiomyoma Clinical Trial

Official title:

Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049242
• Other study ID #: atauni10
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: December 21, 2014
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.

Description:

Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 48 Years

Eligibility

Inclusion Criteria:

• uterine myoma >12 weeks

Exclusion Criteria:

• Pedunculated myoma, broad ligament myoma

• Hb<10.5 g /dl

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Myomectomy
• Uterine Leiomyoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Atatürk Universitesi Arastirma Hastanesi	Erzurum	Yakutiye

Sponsors (2)

Lead Sponsor	Collaborator
Ataturk University	Erzurum Nenehatun Kadin Dogum Hastanesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peri-operative complications	Including but not limited to fever, pelvic infections, wound infections.	6 weeks postoperatively	No
Other	Total operation time		5 minutes post operatively	No
Other	Tourniquet time		5 minutes after tourniquet removed	No
Primary	Estimating 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.; 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.	15 minutes postoperatifly	No
Secondary	The amount of transfusions	Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.	7 Days	No
Secondary	A change in hemoglobin		At baseline and 48 hours after surgery	No
Secondary	Volume in drains	Drain will be removed when discharge drops below 50 ml/day	7 days	No
Secondary	Anti-Mullerian Hormone levels variation	Anti-Mullerian Hormone levels before and 6 months after surgery	6 weeks	No