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Uterine Tourniquet at Open Myomectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ataturk University
Sponsor:
Collaborator:
Erzurum Nenehatun Kadın Doğum Hastanesi
Information provided by (Responsible Party):
Ragıp Atakan Al, Ataturk University
ClinicalTrials.gov Identifier:
NCT02049242
First received: January 28, 2014
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention
Myomectomy
Uterine Leiomyoma
Procedure: triple tourniquet
Procedure: Single tourniquet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials

Resource links provided by NLM:


Further study details as provided by Ataturk University:

Primary Outcome Measures:
  • Estimating blood loss at the end of myomectomy [ Time Frame: 15 minutes postoperatifly ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • The amount of transfusions [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.

  • A change in hemoglobin [ Time Frame: At baseline and 48 hours after surgery ] [ Designated as safety issue: No ]
  • Volume in drains [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Drain will be removed when discharge drops below 50 ml/day

  • Anti-Mullerian Hormone levels variation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Anti-Mullerian Hormone levels before and 6 months after surgery


Other Outcome Measures:
  • Peri-operative complications [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
    Including but not limited to fever, pelvic infections, wound infections.

  • Total operation time [ Time Frame: 5 minutes post operatively ] [ Designated as safety issue: No ]
  • Tourniquet time [ Time Frame: 5 minutes after tourniquet removed ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Triple tourniquet 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.

Active Comparator: Single tourniquet Procedure: 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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • uterine myoma >12 weeks

Exclusion Criteria:

  • Pedunculated myoma, broad ligament myoma
  • Hb<10.5 g /dl
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049242

Contacts
Contact: Ragıp A Al, MD +904423447659 atakanal@gmail.com
Contact: Ömer E Yapca, MD +905052741723 sevabina@gmail.com

Locations
Turkey
Atatürk Universitesi Araştırma Hastanesi Recruiting
Erzurum, Yakutiye, Turkey, 25240
Contact: Ragıp A Al, MD    +904423447659    atakanal@gmail.com   
Sub-Investigator: Ömer E Yapca, MD         
Sponsors and Collaborators
Ataturk University
Erzurum Nenehatun Kadın Doğum Hastanesi
  More Information

No publications provided

Responsible Party: Ragıp Atakan Al, Associate Professor, Ataturk University
ClinicalTrials.gov Identifier: NCT02049242     History of Changes
Other Study ID Numbers: atauni10
Study First Received: January 28, 2014
Last Updated: October 1, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by Ataturk University:
Hemorrhage
Leiomyoma
Myofibroma
Uterine Myomectomy
Tourniquet

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Connective Tissue Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on October 23, 2014