Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

N/ANot Yet RecruitingNCT07746349

Sevil Cankaya80 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Uterine Fibroids (Leiomyoma)

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intraoperative Blood Loss

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).

Time frame: Intraoperative period (from skin incision to skin closure)

Secondary Outcomes

Change in Hemoglobin and Hematocrit Levels

Difference between preoperative and 24-hour postoperative hemoglobin (g/dL) and hematocrit (%) levels

Time frame: Baseline (preoperative) to 24 hours postoperative

Rate of Blood Transfusion

Proportion of participants requiring intraoperative or postoperative blood transfusion

Time frame: From surgery through hospital discharge

Duration of Surgery

Time from skin incision to skin closure, recorded in minutes

Time frame: Intraoperative period

Requirement for Supplementary Hemostatic Intervention

Proportion of participants requiring additional hemostatic measures (e.g., additional sutures, electrocautery) beyond the study intervention

Time frame: Intraoperative period

Change in Blood Pressure

Systolic and diastolic blood pressure measured at predefined time points.

Time frame: Pre-injection through 30 minutes post-injection

Rate of Postoperative Complications

Incidence of complications including wound infection, hematoma, and other surgery-related adverse events

Time frame: Through hospital discharge (and 30-day follow-up, if planned)

Duration of Hospitalization

Number of days from surgery to discharge

Time frame: From the day of surgery until hospital discharge

Change in Heart Rate

Heart rate measured at predefined time points.