Leiomyoma, Uterine Fibroids (Leiomyoma), Uterine Myoma
Conditions
Keywords
Terlipressin, Myomectomy, Uterine Fibroids, Subcapsular Injection, Intraoperative Blood Loss, Vasopressin Analog, Placebo-Controlled Trial
Brief summary
A myomectomy is a surgery to remove noncancerous growths (fibroids) from the uterus while keeping the uterus in place. This surgery can cause significant blood loss. Terlipressin is a medicine that narrows blood vessels and may help reduce bleeding. This study will test whether injecting a diluted terlipressin solution under the outer covering of the fibroid, before it is removed, reduces the amount of blood lost during surgery, compared to an inactive solution (placebo). Women scheduled for myomectomy will be randomly assigned to receive either terlipressin or placebo. Neither the patients nor the surgical team will know which one was given until the study is finished. The main question this study will answer is how much blood is lost during surgery in each group.
Detailed description
Myomectomy is frequently complicated by significant intraoperative bleeding. While vasoconstrictive and uterotonic agents such as vasopressin, carbetocin, and undiluted terlipressin have been studied for hemostasis, no prior trial has evaluated a diluted terlipressin solution administered via the subcapsular route. This study aims to address this gap by comparing 1 mg terlipressin diluted in 40 mL normal saline, injected subcapsularly, versus placebo, with intraoperative blood loss as the primary outcome
Interventions
Terlipressin 1 mg diluted in 40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation
DRUGPlacebo
40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation
Sponsors
Sevil Cankaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be randomly allocated in a 1:1 ratio to receive either subcapsular diluted terlipressin or placebo (saline) injection prior to fibroid enucleation during myomectomy. Both groups will be followed using identical perioperative and postoperative assessment protocols.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Symptomatic uterine fibroid(s) with an indication for myomectomy, including menorrhagia, pelvic pain/pressure, or infertility * Largest myoma diameter between 4 and 10 cm * Baseline hemoglobin ≥ 9 g/dL * Not pregnant at the time of enrollment * Negative urine pregnancy test or last menstrual period within 4 weeks * Willing and able to provide written informed consent
Exclusion criteria
* History of bleeding disorders or coagulopathy * Current anticoagulant or antiplatelet therapy * Known hypersensitivity or contraindication to terlipressin * Uncontrolled hypertension * Severe cardiac arrhythmia * Uncontrolled ischemic heart disease * Peripheral vascular disease * Pregnancy or suspected pregnancy * Previous myomectomy * Concurrent pelvic pathology requiring additional surgical intervention * Treatment with a GnRH agonist or ulipristal acetate within the 3 months preceding surgery * Suspected uterine malignancy, such as leiomyosarcoma * Inability to understand or provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Blood Loss | Intraoperative period (from skin incision to skin closure) | Blood loss will be measured gravimetrically as the difference in weight of surgical sponges and drapes before and after use, plus the volume collected in the suction canister, minus the volume of irrigation fluid used. The result will be expressed in milliliters (mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin and Hematocrit Levels | Baseline (preoperative) to 24 hours postoperative | Difference between preoperative and 24-hour postoperative hemoglobin (g/dL) and hematocrit (%) levels |
| Rate of Blood Transfusion | From surgery through hospital discharge | Proportion of participants requiring intraoperative or postoperative blood transfusion |
| Duration of Surgery | Intraoperative period | Time from skin incision to skin closure, recorded in minutes |
| Requirement for Supplementary Hemostatic Intervention | Intraoperative period | Proportion of participants requiring additional hemostatic measures (e.g., additional sutures, electrocautery) beyond the study intervention |
| Change in Blood Pressure | Pre-injection through 30 minutes post-injection | Systolic and diastolic blood pressure measured at predefined time points. |
| Rate of Postoperative Complications | Through hospital discharge (and 30-day follow-up, if planned) | Incidence of complications including wound infection, hematoma, and other surgery-related adverse events |
| Duration of Hospitalization | From the day of surgery until hospital discharge | Number of days from surgery to discharge |
| Change in Heart Rate | Pre-injection through 30 minutes post-injection | Heart rate measured at predefined time points. |
Contacts
CONTACTSevil Çankaya, MD
CONTACTAhmet Kale, MD
PRINCIPAL_INVESTIGATORSevil Çankaya, MD
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Outcome results
None listed