NCT02049242

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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

January 28, 2014

Last Update Submit

December 21, 2014

Conditions

MyomectomyUterine Leiomyoma

Keywords

HemorrhageLeiomyomaMyofibromaUterine MyomectomyTourniquet

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • The amount of transfusions

    7 Days

  • A change in hemoglobin

    At baseline and 48 hours after surgery

  • Volume in drains

    7 days

  • Anti-Mullerian Hormone levels variation

    6 weeks

Other Outcomes (3)

  • Peri-operative complications

    6 weeks postoperatively

  • Total operation time

    5 minutes post operatively

  • Tourniquet time

    5 minutes after tourniquet removed

Study Arms (2)

Triple tourniquet

ACTIVE COMPARATOR
Procedure: triple tourniquet

Single tourniquet

ACTIVE COMPARATOR
Procedure: Single tourniquet

Interventions

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
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

Eligibility Criteria

Age16 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • uterine myoma \>12 weeks

You may not qualify if:

  • Pedunculated myoma, broad ligament myoma
  • Hb\<10.5 g /dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Universitesi Araştırma Hastanesi

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

MyofibromaHemorrhageLeiomyoma

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

TU(1)