Single or Triple Uterine Tourniquet at Myomectomy

NCT ID: NCT02392585

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-05-31

Brief Summary

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

Detailed Description

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Conditions

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Uterine Myoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single tourniquet

Group Type ACTIVE_COMPARATOR

Single tourniquet

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Triple tourniquet

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ragıp Atakan Al

OTHER

Sponsor Role lead

Responsible Party

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Ragıp Atakan Al

Assoc.Prof

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Neset Gümüsburun, MD

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Atatürk Üniversitesi Araştırma Hastanesi

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 37672088 (View on PubMed)

Other Identifiers

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ATAUNİ23

Identifier Type: -

Identifier Source: org_study_id

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