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NCT Number: NCT02049242

Uterine Tourniquet at Open Myomectomy

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

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Key information

Conditions

Myomectomy Connective Tissue Diseases Hemorrhage Leiomyoma Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases Uterine Leiomyoma

Age range

16 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk Universitesi Araştırma Hastanesi

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

About this study

Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • uterine myoma >12 weeks

Exclusion criteria

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

Treatment and study plan

triple tourniquet

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.

Single tourniquet

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.

Primary outcomes

  1. Estimating blood loss at the end of myomectomy

    Time frame: 15 minutes postoperatifly

    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.

Secondary outcomes

  1. The amount of transfusions

    Time frame: 7 Days

    Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.

  2. A change in hemoglobin

    Time frame: At baseline and 48 hours after surgery

  3. Volume in drains

    Time frame: 7 days

    Drain will be removed when discharge drops below 50 ml/day

  4. Anti-Mullerian Hormone levels variation

    Time frame: 6 weeks

    Anti-Mullerian Hormone levels before and 6 months after surgery

Other outcomes

  1. Peri-operative complications

    Time frame: 6 weeks postoperatively

    Including but not limited to fever, pelvic infections, wound infections.

  2. Total operation time

    Time frame: 5 minutes post operatively

  3. Tourniquet time

    Time frame: 5 minutes after tourniquet removed

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • Erzurum Nenehatun Kadın Doğum Hastanesi

Registry information

Official study title

Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2014
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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