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Uterine Tourniquet at Open Myomectomy

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ClinicalTrials.gov Identifier: NCT02049242
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : December 23, 2014
Sponsor:
Collaborator:
Erzurum Nenehatun Kadın Doğum Hastanesi
Information provided by (Responsible Party):
Ragıp Atakan Al, Ataturk University

January 28, 2014
January 30, 2014
December 23, 2014
January 2014
December 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02049242 on ClinicalTrials.gov Archive Site
  • The amount of transfusions [ Time Frame: 7 Days ]
    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 ]
  • Volume in drains [ Time Frame: 7 days ]
    Drain will be removed when discharge drops below 50 ml/day
  • Anti-Mullerian Hormone levels variation [ Time Frame: 6 weeks ]
    Anti-Mullerian Hormone levels before and 6 months after surgery
  • The amount of transfusions [ Time Frame: 7 Days ]
    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 ]
  • Volume in drains [ Time Frame: 7 days ]
    Drain will be removed when discharge drops below 50 ml/day
  • Anti-Mullerian Hormone levels variation [ Time Frame: 6 months ]
    Anti-Mullerian Hormone levels before and 6 months after surgery
  • Peri-operative complications [ Time Frame: 6 weeks postoperatively ]
    Including but not limited to fever, pelvic infections, wound infections.
  • Total operation time [ Time Frame: 5 minutes post operatively ]
  • Tourniquet time [ Time Frame: 5 minutes after tourniquet removed ]
Same as current
 
Uterine Tourniquet at Open Myomectomy
Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials
The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.
Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Myomectomy
  • Uterine Leiomyoma
  • 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.

  • 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.
  • Active Comparator: Triple tourniquet
    Intervention: Procedure: triple tourniquet
  • Active Comparator: Single tourniquet
    Intervention: Procedure: Single tourniquet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
30
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • uterine myoma >12 weeks

Exclusion Criteria:

  • Pedunculated myoma, broad ligament myoma
  • Hb<10.5 g /dl
Sexes Eligible for Study: Female
16 Years to 48 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT02049242
atauni10
No
Not Provided
Not Provided
Ragıp Atakan Al, Ataturk University
Ataturk University
Erzurum Nenehatun Kadın Doğum Hastanesi
Not Provided
Ataturk University
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP