Misoprostol for Uterine fibroid

Inclusion criteria

• {"criterion_text":"- Patient aged 18 to 43"}
• {"criterion_text":"- Symptomatic myomas (hemorrhages, pain or infertility)"}
• {"criterion_text":"- Indication for myomectomy by laparoscopy Fibroid ≤ 10cm or number ≤ 4 fibroids"}
• {"criterion_text":"- Indication for myomectomy by laparotomy Fibroid > 10cm, Number > 4 fibroids"}
• {"criterion_text":"- OTAU possible intraoperatively (Clip on uterine artery and Placement of a turnstile)"}

Exclusion criteria

• {"criterion_text":"- History of major uterine surgery or myomectomy (excluding myomectomy by hysteroscopy)"}
• {"criterion_text":"- Allergy to misoprostol"}
• {"criterion_text":"- Patient on aspirin or anticoagulant"}
• {"criterion_text":"- Patients with a hemostasis disorder"}
• {"criterion_text":"- Patient with hypersensitivity to misoprostol and/or other prostaglandins or to any of the excipients of the product"}
• {"criterion_text":"- Malnourished patients"}
• {"criterion_text":"- Patients with hepatic or renal impairment"}
• {"criterion_text":"- Pregnancy, suspected ectopic pregnancy and breastfeeding women."}

Primary endpoints

• {"endpoint_text":"- Intraoperative blood loss measured in mL (volume in the suction and blood volumes in the compresses after weighing) according to the randomization group.","definition_or_measurement_approach":"Measured in mL: volume in suction plus blood volumes in compresses after weighing, compared by randomization group."}

Secondary endpoints

• {"endpoint_text":"- Depending on the randomization group, compare the difference in hemoglobin pre- and post-operatively then at 1 month and hemoglobin level","definition_or_measurement_approach":"Difference in hemoglobin measured pre-operatively, post-operatively and at 1 month; comparison between randomization groups."}
• {"endpoint_text":"- Depending on the randomization group, compare: Demographic characteristics of patients and fibroids: BMI, Age, Gesture, Parity, Ethnicity, Tobacco, Taking pre-operative hormonal treatment, Type of treatment.","definition_or_measurement_approach":"Collection and comparison of demographic and clinical variables (BMI, age, gravidity, parity, ethnicity, tobacco use, pre-op hormonal treatment, treatment type) by randomization group."}
• {"endpoint_text":"- Depending on the randomization group, compare: Characteristics of myomas: Types of myomas (FIGO), Size of myomas, Number of myomas.","definition_or_measurement_approach":"Assessment and comparison of myoma characteristics (FIGO type, size, number) between groups."}
• {"endpoint_text":"- Depending on the randomization group, compare the duration between taking the tablet and anesthetic induction then the incision","definition_or_measurement_approach":"Time interval (tablet intake to anesthetic induction and to incision) recorded and compared between groups."}
• {"endpoint_text":"- Depending on the randomization group, compare the duration between incision or pneumoperitoneum and closure","definition_or_measurement_approach":"Operative time measured from incision or pneumoperitoneum start to closure; compared between groups."}
• {"endpoint_text":"- Depending on the randomization group, compare the accounting for the number of RGCs transfused.","definition_or_measurement_approach":"Number of red blood cell concentrates (RGCs) transfused recorded and compared between groups."}
• {"endpoint_text":"- Depending on the randomization group, compare the collection of early postoperative complications.","definition_or_measurement_approach":"Recording of early postoperative complications and comparison between groups."}
• {"endpoint_text":"- Depending on the randomization group, compare : EVA at H+2, H+6 D1 M1.","definition_or_measurement_approach":"Pain (EVA/VAS) measured at H+2, H+6, Day 1 and Month 1 and compared between groups."}
• {"endpoint_text":"- Depending on the randomization group, compare : Length of hospitalization in days.","definition_or_measurement_approach":"Length of hospital stay in days recorded and compared between groups."}
• {"endpoint_text":"- Depending on the type of surgery compare the difference in hemoglobin pre- and post-operatively then at 1 month and hemoglobin level","definition_or_measurement_approach":"Difference in hemoglobin measured pre-op, post-op and at 1 month, compared according to surgical technique (laparoscopy vs laparotomy)."}
• {"endpoint_text":"- Depending on the type of surgery compare the demographic characteristics of patients and fibroids: BMI, Age, Gesture, Parity, Ethnicity, Tobacco, Taking pre-operative hormonal treatment, Type of treatment.","definition_or_measurement_approach":"Demographic and clinical variables collected and compared by surgical technique."}
• {"endpoint_text":"- Depending on the type of surgery compare the characteristics of myomas: Types of myomas (FIGO), Size of myomas, Number of myomas.","definition_or_measurement_approach":"Myoma characteristics (FIGO type, size, number) assessed and compared by surgical technique."}
• {"endpoint_text":"- Depending on the type of surgery compare the duration between taking the tablet and anesthetic induction then the incision","definition_or_measurement_approach":"Time from tablet intake to anesthetic induction and incision measured and compared by surgical technique."}
• {"endpoint_text":"- Depending on the type of surgery compare the duration between incision or pneumoperitoneum and closure.","definition_or_measurement_approach":"Operative time (incision/pneumoperitoneum to closure) measured and compared by surgical technique."}
• {"endpoint_text":"- Depending on the type of surgery compare the accounting for the number of RGCs transfused.","definition_or_measurement_approach":"Number of RGCs transfused recorded and compared by surgical technique."}
• {"endpoint_text":"- Depending on the type of surgery compare the collection of early postoperative complications.","definition_or_measurement_approach":"Early postoperative complications collected and compared by surgical technique."}
• {"endpoint_text":"- Depending on the type of surgery compare EVA at H+2, H+6 D1 M1","definition_or_measurement_approach":"EVA/VAS pain scores at H+2, H+6, Day 1 and Month 1 compared by surgical technique."}
• {"endpoint_text":"- Depending on the type of surgery compare the length of hospitalization in days.","definition_or_measurement_approach":"Length of hospital stay in days compared by surgical technique."}
• {"endpoint_text":"- Intraoperative blood loss measured in mL (volume in aspiration and blood volumes in compresses after weighing) according to the randomization group and surgical technique.","definition_or_measurement_approach":"Measured intraoperative blood loss in mL (suction volume + blood in compresses after weighing) compared by randomization group and by surgical technique."}

France

Earliest CTIS Part Ii Submission Date

07-11-2024

Latest Decision Or Authorization Date

05-06-2025

Processing Time Days

210

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

University Hospital Of Clermont-Ferrand

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France