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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.

triple 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.

Single tourniquet

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.

Uterine Tourniquet at Open Myomectomy

Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials

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

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.

Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.

Drain will be removed when discharge drops below 50 ml/day

Anti-Mullerian Hormone levels before and 6 months after surgery

Erzurum Nenehatun Kadın Doğum Hastanesi

Ataturk University

Associate Professor

Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure are treated with the Philips MR-guided HIFU system. Patients must have completed child bearing prior to enrolling in this study.

HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.

Philips MR-guided HIFU system

Erik Fosse, Professor

This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to collect supplementary 3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients.

Fibroids occur in 20-50% of women over 30 years of age, and with increasing size produce pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids may also cause infertility. Uterine leiomyomas are benign tumors originating from smooth muscle cells of the uterus and occasionally the smooth muscle of uterine blood vessels. Fibroids are estrogen dependent tumors ranging in size and number and can be found within the myometrium(intramural), at the uterine periphery extending to the serosa (subserosal), or pushing into the uterine cavity (submucosal). Symptomatic fibroids impact health and well-being of the female including lost work hours and reduced quality of life.

Current medical treatments include invasive removal of the fibroid (hysterectomy, myomectomy), drug therapy (GnRH analogues or progestin compounds) or treatments causing necrosis of the fibroid tissue such as ablation (freezing or heating) or embolization. For the relief of symptoms, women wishing to preserve the uterus may choose between invasive procedures of myomectomy, Uterine Artery Embolization (UAE), ablation or cryotherapy. The surgically invasive procedures require anesthesia, hospital stays, and long recovery periods. HIFU may offer an alternative to the above mentioned surgically invasive procedures.

In MRI-guided High Intensity Focused Ultrasound (HIFU), the ultrasound generated by the transducer is focused into a small focal tissue volume at specific target locations. During treatment, the beam of focused ultrasound energy penetrates through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis. The MRI system allows 3D planning, means of measuring the temperature increase generated by HIFU, and the capability to quantifying the energy/dose delivered to the treatment zone.

This study is a single-center, single arm, non-randomized trial evaluating the safety, technical effectiveness and volume treatment capabilities of the Philips MR-guided HIFU system in the treatment of symptomatic uterine fibroid patients. Patients who have symptomatic uterine fibroids, who are eligible according to the inclusion and exclusion criteria and provide informed consent will be enrolled in this study. It is anticipated that women will participate in the study for a 2month period to include the screening, HIFU treatment and post treatment follow-up.

This clinical study is designed to confirm safety and demonstrate technical effectiveness of the Philips HIFU system for Uterine Fibroid treatment. Safety will be primarily assessed by evaluating minor complications and adverse events, and technical effectiveness will primarily be assessed with MRI measurements. Specific primary and secondary endpoints are detailed below.

The study will use a combination of three primary endpoints: MR imaging of ablated volumes and minor complications/adverse events analysis to establish the safety and technical effectiveness of the Philips MR-HIFU system. These endpoints will determine the trial success.

The treatment capabilities and technical effectiveness of the Philips MR-guided HIFU system will be assessed by (measurement type is noted in parentheses)

1. Comparing the actual MR-measured ablated volumes to MR thermal dose predicted volumes Safety of the Philips MR-guided HIFU system will be demonstrated by
2. Evaluating any minor complications or adverse events that result from the MR-guided HIFU treatment
3. Verifying with MR imaging that no unintended lesions are formed as a result of the Treatment

   In addition, the following endpoints will be collected to supplement the primary outcomes:
4. Pain and discomfort scores before, during and after treatment: These endpoints will be recorded using a 10-point visual analog scale for pain 4-point scale for discomfort.
5. Return to Activity: This duration in days will be determined by the time after which the patients return to work (i.e. days after leaving the hospital) or to the usual activities for those not employed.
6. Length of Hospital Stay (LOS): This duration in hours will be measured from the time the patient will arrive to the hospital until she will leave the hospital.
7. Quality of Life questionnaires: the SF-36(http://www.sf36.org/tools/SF36.shtml) and UFS-QoL (which includes SSS)

Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner

Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids in a 3T MRI Scanner

Number of adverse events reported in the study divided by the total number of treated subjects.

Mean absolute change in the Symptom Severity Score (SSS) of the uterine Fibroid Symptoms Quality of Life questionnaire from baseline to 30 days after treatment.

Mean absolute score change in the Quality of Life questionnaire from baseline to 30 days after treatment.

Mean Visual Analog Score (VAS) for pain 72 hours after treatment.

Mean timeframe for the patient to return to normal activity after treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Uterine Tourniquet at Open Myomectomy	NCT02049242	Myomectomy Uterine Leiomyo...	triple tourniqu... Single tourniqu...	16 Years - 48 Years	Ataturk University
Uterine Tourniquet at Open Myomectomy	NCT02049242	Myomectomy Uterine Leiomyo...	triple tourniqu... Single tourniqu...	16 Years - 48 Years	Ataturk University
Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner	NCT01064960	Uterine Leiomyo...	Philips MR-guid...	18 Years - 59 Years	Philips Healthcare

Spots Global Cancer Trial Database for myofibroma

Every month we try and update this database with for myofibroma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for myofibroma

Every month we try and update this database with for myofibroma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for myofibroma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.