Single or Triple Uterine Tourniquet at Myomectomy

Sponsor

Ragıp Atakan Al (Other)

Overall Status

Completed

CT.gov ID

NCT02392585

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Myoma	Procedure: Single tourniquet Procedure: Triple tourniquet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single tourniquet	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.
Active Comparator: Triple tourniquet	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.

Arm

Intervention/Treatment

Active Comparator: Single tourniquet

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.

Active Comparator: Triple tourniquet

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
Peri-operative complications [6 weeks]
Including but not limited to fever, pelvic infections, wound infections.
Total operation time [5 minutes post operatively]
Skin to skin operation time
Tourniquet time [5 minutes after tourniquet removed]

Other Outcome Measures

Anti-Mullerian Hormone levels variation [One year postoperatively]
Anti-Mullerian Hormone levels before surgery, 6 months and 12 months after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 48 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atatürk Üniversitesi Araştırma Hastanesi	Erzurum		Turkey	25240

Sponsors and Collaborators

Ragıp Atakan Al

Investigators

Principal Investigator: Neset Gümüsburun, MD, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ragıp Atakan Al, Assoc.Prof, Ataturk University

ClinicalTrials.gov Identifier:

NCT02392585

Other Study ID Numbers:

ATAUNİ23

First Posted:

Mar 19, 2015

Last Update Posted:

Feb 12, 2019

Last Verified:

Feb 1, 2019

Keywords provided by Ragıp Atakan Al, Assoc.Prof, Ataturk University

Leiomyoma of uterus

Hemostasis, Surgical

Prevention of Surgical Blood Loss

mechanical uterine tourniquet

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Feb 12, 2019