participants receive a single dose of 400mcg vaginal misoprostol preoperatively (60minutes before) during open myomectomy

Uterine Fibroid

insertion of a preoperative single dose 400 micrograms of Misoprostol Pfizer Brand placed vaginally

Misoprostol Pfizer Brand

participants in this arm will receive the standard of care which in our setting involves the use of either a tourniquet to control intraoperative blood loss especially if the fibroids are large or rarely, other interventions like oxytocin, tranexamic acid, vasopressin and occasionally not using either of the interventions.

Non-insertion of Misoprostol Pfizer Brand

Makerere University

The Efficacy and Safety of Preoperative Misoprostol in Blood-loss Reduction During Myomectomy.

Efficacy and Safety of Pre-operative Vaginal Misoprostol in Reduction of Intraoperative Blood Loss During Myomectomy. Amulticentre Single Blind Randomized Trial.

Soaked mops will be weighed and blood loss estimated by subtracting the soaked weight from the dry weight and by multiplying this by 1.060 (average density of human blood is 1.06g/ml); a volume in ml would be acquired. Only mops are intended to be routinely used during the operation for cleaning and clearing the operation field although measurement of blood collected in the suction cylinder in milliliters if used will also be added. Adequate mops will be provided to avoid any spillage onto the operating table polythene sheet. A standardized digital weighing scale will be availed in each operating room. Any spillage onto the bed, however, will be collected in a polythene sheet and poured into a measuring cylinder for quantification.

from incision time to time for insertion of last stitch

number of days spent within the hospital post-operatively

hemodynamic instability during and after open myomectomy following profuse hemorrhage as assessed by the clinicians.

death, massive transfusion >5 units of blood, development of deep venous thrombosis pulmonary edema and pulmonary embolism

Hemoglobin estimation done both pre- and post-operatively; difference between the two values to be a measure of amount of blood lost. patients that receive blood transfusion to be excluded.

College of Health Sciences

Principal Investigator

multicenter-randomized single blind controlled trial with a (1:1) allocation ratio.

Pre-treatment imaging
Pre-treatment questionnaires and laboratory blood samples
Intervention (Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T)
Follow-up (imaging, questionnaires, laboratory)
Follow-up pain medication usage

Pre-treatment imaging
Pre-treatment questionnaires and laboratory blood samples
Intervention (Varian Truebeam Radiotherapy System)
Follow-up (imaging, questionnaires, laboratory)
Follow-up pain medication usage

Bone Metastases

Bone Neoplasm

Bone Cancer

Bone Lesion

Procedure is performed under proper analgesia (general or local anesthesia). The intervention can be performed in areas accessible with ultrasound with no critical structures (nerves, vasculature, bowels) in proximity. Limbs and pelvis are most usually accepted locations.
Patient is adjusted on top of the HIFU-transducer connected to MRI. First a MR-scan is performed and the treatment procedure is planned on consol. Then under MRI-guidance a point by point ablation of the target tumor is performed. During the treatment a real-time thermometry is obtained in order to avoid unwanted heating of related structures and to observe sufficient effect on treatment zone. After treatment MR-scan with gadolinium is performed to evaluate the size of ablated area.

Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T

Conventional radiotherapy focused on bone tumor. Pretreatment planning images acquired with computer tomography

Varian Truebeam Radiotherapy System

MR Imaging- Guided High Intensity Focused Ultrasound (HIFU) Therapy of Bone Metastases

Change in Visual analog scale pretreatment vs follow-up

Changes in tumor features pretreatment vs follow-up (signs of progression or regression)

Change in the use of strong opiate-based pain medication intake pretreatment vs follow-up

Change in SF-36 questionnaire pretreatment vs follow-up. SF36 is translated in finnish. It measures several variables related to quality of life ( eg mood, need of help)

Change in serum inflammatory cytokines pretreatment vs follow-up

Change in serum tumor-specific markers (eg. PSA for prostate cancer patients) pretreatment vs follow-up

Possible adverse effects found during treatment or in follow up will be collected and reported

Possible collaboration in the future with Karolinska Institute, Stockholm, during later stages of the study when performing randomized experiments. Data to be shared would be MRI- and CT-data, laboratory results and health-questionnaire results.

Turku University Hospital

Potential participants are recruited by oncologist from oncology outpatient clinic. Pretreatment imaging with computer tomography and magnetic resonance imaging is performed to evaluate whether the patient is eligible for HIFU-treatment. Those eligible will continue to the treatment and unsuitable participants will continue in the study as a control group receiving radiation therapy.
Participants in these groups will have follow-up MRI:s, ct:s, laboratory exams and fill in VAS (visual analog scale) and health questionnaire SF-36 regularly. Also intake of pain medication will be followed.

myoma/fever

The Efficacy and Safety of Preoperative Misoprostol in Blood-loss Reduction During Myomectomy.

MR Imaging- Guided High Intensity Focused Ultrasound (HIFU) Therapy of Bone Metastases

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