Single or Triple Uterine Tourniquet at Myomectomy

Uterine Myoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392585
• Other study ID #: ATAUNI23
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 2017

Study information

• Verified date: February 2019
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Myoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Atatürk Üniversitesi Arastirma Hastanesi	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ragip Atakan Al

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-Mullerian Hormone levels variation	Anti-Mullerian Hormone levels before surgery, 6 months and 12 months after surgery	One year postoperatively
Primary	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	The amount of transfusions	Erythrocyte transfusions will be allowed when haemoglobin dropped below 8 g/dL.	7 Days
Secondary	A change in hemoglobin		At baseline and 48 hours after surgery
Secondary	Volume in drains	Drain will be removed when discharge drops below 50 ml/day	7 days
Secondary	Peri-operative complications	Including but not limited to fever, pelvic infections, wound infections.	6 weeks
Secondary	Total operation time	Skin to skin operation time	5 minutes post operatively
Secondary	Tourniquet time		5 minutes after tourniquet removed