Ultrasound for Assessment of Intra-Abdominal Blood Loss After Gynecological Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorHoly Family Hospital, Nazareth, Israel
About this trial
This is a prospective cohort study designed to assess intra-abdominal blood volume and hemodynamic status by measuring the diameter of the inferior vena cava (IVC) using 3D and Doppler ultrasound within 24 hours after gynecological surgery. The study will examine the association between these ultrasound findings and postoperative outcomes, including hemoglobin drop, need for blood transfusion, pain, infection, and length of hospitalization. Approximately 250 women undergoing laparotomy, laparoscopy, or vaginal surgery at Holy Family Hospital will be enrolled. The study also aimed to define postoperative normograms for fluid volume and IVC parameters and to evaluate whether ultrasound-guided decision-making could improve postoperative care and reduce unnecessary interventions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 years and older
Undergoing gynecological surgery including laparotomy, laparoscopy, and vaginal pelvic surgery
Able to provide informed consent
Disqualifiers
Undergoing minor procedures (e.g., dilation and curettage, hysteroscopy, or cervical conization)
Known preoperative coagulation disorders
Postoperative admission to the intensive care unit (ICU)
Clinical indication requiring ultrasound as part of standard postoperative care
Trial population
Women aged 18 years and older undergoing gynecological surgery (open, laparoscopic, or vaginal) at Holy Family Hospital in Nazareth, Israel.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound
Diagnostic testTransabdominal and transvaginal imaging will be performed to eligible women following gynecological surgery within 24 - 48 hours.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Study group1 intervention
Trial outcomes
Primary outcomes
1
Incidence of intra-abdominal free fluid
Detection of any intra-abdominal or pelvic free fluid via ultrasound examination within 24 - 48 hours after gynecological surgery.
Time frame
Within 24-48 hours after surgerySecondary outcomes
1
Volume of intra-abdominal fluid
Measured in mL using 3D ultrasound
Time frame
Within 24-48 hours after surgery2
Presence and size of pelvic hematoma
Using ultrasound to identify hematomas and measure their volume
Time frame
Within 24-48 hours after surgery3
Inferior vena cava (IVC) diameter and collapsibility index
Using ultrasound Doppler to measure Inferior vena cava (IVC) diameter and collapsibility index
Time frame
Within 24-48 hours after surgery4
Hemoglobin drop
Delta hemoglobin level before surgery and at 48-72 hours postoperatively.
Time frame
Within 24-48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov