NCT02392585

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

March 13, 2015

Last Update Submit

February 9, 2019

Conditions

Uterine Myoma

Keywords

Leiomyoma of uterusHemostasis, SurgicalPrevention of Surgical Blood Lossmechanical uterine tourniquet

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The amount of transfusions

    7 Days

  • A change in hemoglobin

    At baseline and 48 hours after surgery

  • Volume in drains

    7 days

  • Peri-operative complications

    6 weeks

  • Total operation time

    5 minutes post operatively

  • +1 more secondary outcomes

Other Outcomes (1)

  • Anti-Mullerian Hormone levels variation

    One year postoperatively

Study Arms (2)

Single tourniquet

ACTIVE COMPARATOR
Procedure: Single tourniquet

Triple tourniquet

ACTIVE COMPARATOR
Procedure: Triple tourniquet

Interventions

Single tourniquetPROCEDURE

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.

Single tourniquet
Triple tourniquetPROCEDURE

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.

Triple tourniquet

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Three or more uterine myoma
  • At least one myoma ≥ 8 cm, if there is less than three myoma

You may not qualify if:

  • Pedunculated myoma,
  • broad ligament myoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Üniversitesi Araştırma Hastanesi

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

  • Gumusburun N, Yapca OE, Ozdes S, Al RA. Triple vs. single uterine tourniquet to reduce hemorrhage at myomectomy: a randomized trial. Arch Gynecol Obstet. 2023 Dec;308(6):1811-1816. doi: 10.1007/s00404-023-07201-7. Epub 2023 Sep 6.

    PMID: 37672088DERIVED

MeSH Terms

Conditions

Myofibroma

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Neset Gümüsburun, MD

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2017

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

TU(1)