MyomectomyNCT02049242
Uterine Tourniquet at Open Myomectomy
A study testing triple tourniquet and Single tourniquet in people with Myomectomy and Uterine Leiomyoma, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy. Read more about this study
- Who is it for?
- Ages 16 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myomectomy, Uterine Leiomyoma
- What is being tested?
- triple tourniquet and Single tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 48 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- uterine myoma >12 weeks
Who cannot join
- Pedunculated myoma, broad ligament myoma
- Hb<10.5 g /dl
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Universitesi Araştırma Hastanesi
Erzurum, Yakutiye, 25240
About this study
Official title: 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.
Read the detailed description
Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.
- Conditions
- Myomectomy, Uterine Leiomyoma
- Being tested
- triple tourniquet, Single tourniquet
- Keywords
- Hemorrhage, Leiomyoma, Myofibroma, Uterine Myomectomy, Tourniquet
- Medical subject headings
- Myofibroma, Hemorrhage, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple tourniquetProcedure or surgery
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 tourniquetProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Triple tourniquet | Active comparator | Not described Receives: Procedure: triple tourniquet |
| Single tourniquet | Active comparator | Not described Receives: Procedure: Single tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimating blood loss at the end of myomectomy
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.
Measured: 15 minutes postoperatifly
Secondary outcomes (4)
The amount of transfusions
Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.
Measured: 7 Days
A change in hemoglobin
Measured: At baseline and 48 hours after surgery
Volume in drains
Drain will be removed when discharge drops below 50 ml/day
Measured: 7 days
Anti-Mullerian Hormone levels variation
Anti-Mullerian Hormone levels before and 6 months after surgery
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomectomyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Erzurum Nenehatun Kadın Doğum Hastanesi
- Responsible party
- Principal investigator, Ragıp Atakan Al, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049242
- Sponsor's protocol ID
- atauni10
- Status last verified
- Dec 2014
- First submitted
- 28 Jan 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials
- ClinicalTrials.gov ID
- NCT02049242
- Acronym / sponsor ID
- atauni10
- Conditions
- Myomectomy, Uterine Leiomyoma
- Keywords
- Hemorrhage, Leiomyoma, Myofibroma, Uterine Myomectomy, Tourniquet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- Erzurum Nenehatun Kadın Doğum Hastanesi
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.
Detailed description
Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple tourniquet | Active comparator | Procedure: triple tourniquet |
| Single tourniquet | Active comparator | Procedure: Single tourniquet |
Who may qualify
- Ages
- 16 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- uterine myoma >12 weeks
Key exclusion criteria (2 listed)
- Pedunculated myoma, broad ligament myoma
- Hb<10.5 g /dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triple tourniquetTriple 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 or surgery | Triple tourniquet |
| Single tourniquetSingle 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. | Procedure or surgery | Single tourniquet |
Primary outcome
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.
4 secondary outcomes
The amount of transfusions
Time frame: 7 Days
A change in hemoglobin
Time frame: At baseline and 48 hours after surgery
Volume in drains
Time frame: 7 days
Anti-Mullerian Hormone levels variation
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triple tourniquet and Single tourniquet in people with Myomectomy and Uterine Leiomyoma, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimating blood loss at the end of myomectomy (time frame: 15 minutes postoperatifly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.