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Completed

NCT Number: NCT02392585

Single or Triple Uterine Tourniquet at 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

Uterine Myoma Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk Üniversitesi Araştırma Hastanesi

Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Estimated blood loss at the end of myomectomy

    Time frame: 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 outcomes

  1. The amount of transfusions

    Time frame: 7 Days

    Erythrocyte transfusions 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. Peri-operative complications

    Time frame: 6 weeks

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

  5. Total operation time

    Time frame: 5 minutes post operatively

    Skin to skin operation time

  6. Tourniquet time

    Time frame: 5 minutes after tourniquet removed

Other outcomes

  1. Anti-Mullerian Hormone levels variation

    Time frame: One year postoperatively

    Anti-Mullerian Hormone levels before surgery, 6 months and 12 months after surgery

Sponsors and collaborators

Lead sponsor

Ragıp Atakan Al

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 19, 2015
Registry last updated
Feb 12, 2019

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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