Uterine MyomaNCT02392585
Single or Triple Uterine Tourniquet at Myomectomy
A study testing Single tourniquet and Triple tourniquet in people with Uterine Myoma, run by Ragıp Atakan Al 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 18 to 48 years, women only
- Conditions the study is for
- Uterine Myoma
- What is being tested?
- Single tourniquet and Triple tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to May 2017
- 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 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Three or more uterine myoma
- At least one myoma ≥ 8 cm, if there is less than three myoma
Who cannot join
- Pedunculated myoma,
- broad ligament myoma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Üniversitesi Araştırma Hastanesi
Erzurum, 25240
About this study
Official title: Triple Tourniquet vs. Single Tourniquet to Reduce Haemorrhage During Myomectomy: a Prospective Randomised Controlled Trial
The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.
- Conditions
- Uterine Myoma
- Being tested
- Single tourniquet, Triple tourniquet
- Keywords
- Leiomyoma of uterus, Hemostasis, Surgical, Prevention of Surgical Blood Loss, mechanical uterine tourniquet
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single tourniquet | Active comparator | Not described Receives: Procedure: Single tourniquet |
| Triple tourniquet | Active comparator | Not described Receives: Procedure: Triple tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated 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.
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.
Measured: 15 minutes postoperatively
Secondary outcomes (6)
The amount of transfusions
Erythrocyte transfusions 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
Peri-operative complications
Including but not limited to fever, pelvic infections, wound infections.
Measured: 6 weeks
Total operation time
Skin to skin operation time
Measured: 5 minutes post operatively
Tourniquet time
Measured: 5 minutes after tourniquet removed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine MyomaStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ragıp Atakan Al
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ragıp Atakan Al, Ataturk University
- Investigators
- Neset Gümüsburun, MD, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392585
- Sponsor's protocol ID
- ATAUNİ23
- Status last verified
- Feb 2019
- First submitted
- 13 Mar 2015
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Gumusburun N, Yapca OE, Ozdes S, Al RA. Triple vs. single uterine tourniquet to reduce hemorrhage at myomectomy: a randomized trial. Arch Gynecol Obstet. 2023 Dec;308(6):1811-1816. doi: 10.1007/s00404-023-07201-7. Epub 2023 Sep 6.
PubMed 37672088
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Tourniquet vs. Single Tourniquet to Reduce Haemorrhage During Myomectomy: a Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02392585
- Acronym / sponsor ID
- ATAUNİ23
- Conditions
- Uterine Myoma
- Keywords
- Leiomyoma of uterus, Hemostasis, Surgical, Prevention of Surgical Blood Loss, mechanical uterine tourniquet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ragıp Atakan AlUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Mar 2015 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single tourniquet | Active comparator | Procedure: Single tourniquet |
| Triple tourniquet | Active comparator | Procedure: Triple tourniquet |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Three or more uterine myoma
- At least one myoma ≥ 8 cm, if there is less than three myoma
Key exclusion criteria (2 listed)
- Pedunculated myoma,
- broad ligament myoma
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 |
|---|---|---|
| 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 |
| 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 |
Primary outcome
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.
6 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
Peri-operative complications
Time frame: 6 weeks
Total operation time
Time frame: 5 minutes post operatively
Tourniquet time
Time frame: 5 minutes after tourniquet removed
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 12 Feb 2019.
- Derived from this study: PubMed 37672088Gumusburun N, Yapca OE, Ozdes S, Al RA. Triple vs. single uterine tourniquet to reduce hemorrhage at myomectomy: a randomized trial. Arch Gynecol Obstet. 2023 Dec;308(6):1811-1816. doi: 10.1007/s00404-023-07201-7. Epub 2023 Sep 6.
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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.
Neset Gümüsburun, MD principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single tourniquet and Triple tourniquet in people with Uterine Myoma, run by Ragıp Atakan Al 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 2 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 12 Feb 2019. 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?
Estimated blood loss at the end of myomectomy (time frame: 15 minutes postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392585, which also lists 1 linked publication.
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 12 Feb 2019.