Clinical trial NCT06953141: Ultrasound for Assessment of Intra-Abdominal Blood Loss After Gynecological Surgery
Official title: Ultrasound Use to Estimate the Amount of Intra-abdominal Blood Following Gynecological Surgeries and the Association With Postoperative Outcomes. A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Operative Hematoma at Operative Site (Diagnosis)
Post-Operative Hemorrhage
Lead sponsor: Holy Family Hospital, Nazareth, Israel
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 years and older undergoing gynecological surgery (open, laparoscopic, or vaginal) at Holy Family Hospital in Nazareth, Israel.

Brief summary: 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.

Detailed description: Postoperative intra-abdominal bleeding is a significant contributor to morbidity and, in some cases, mortality following gynecological surgery. Timely recognition of intra-abdominal blood loss is essential for appropriate clinical intervention. In cases where bleeding is into the abdominal cavity, diagnosis is more difficult and may be delayed.

Ultrasound is a non-invasive, rapid, and widely available tool for assessing free intra-abdominal and pelvic fluid. Modern machines allow for 3D volumetric assessment of fluid collections, as well as Doppler-based measurements of the inferior vena cava (IVC) diameter and its collapsibility index-both of which are known to correlate with intravascular volume status and blood loss. Currently, there are limited data establishing normal ranges of intra-abdominal fluid or IVC diameter postoperatively, and little is known about the magnitude of these measurements and clinical outcomes after gynecologic procedures.

This prospective cohort study aims to quantify intra-abdominal fluid and determine IVC diameter and its collapsibility index using advanced ultrasound imaging within 24 hours after surgery. Patients undergoing open, laparoscopic, or vaginal gynecological procedures will be included. The study will explore correlations between ultrasound findings and clinical outcomes such as hemoglobin drop, need for blood transfusion, infection, pain, and length of hospital stay. Additionally, we aim to develop reference normograms for postoperative normal ranges of intraabdominal fluid volume and IVC diameter.

Eligibility criteria: Inclusion Criteria:

* Women aged 18 years and older
* Undergoing gynecological surgery including laparotomy, laparoscopy, and vaginal pelvic surgery
* Able to provide informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of intra-abdominal free fluid
timeFrame: Within 24-48 hours after surgery
Secondary outcomes:
measure: Volume of intra-abdominal fluid
timeFrame: Within 24-48 hours after surgery
measure: Presence and size of pelvic hematoma
timeFrame: Within 24-48 hours after surgery
measure: Inferior vena cava (IVC) diameter and collapsibility index
timeFrame: Within 24-48 hours after surgery
measure: Hemoglobin drop
timeFrame: Within 24-48 hours after surgery
measure: Need for blood transfusion
timeFrame: Within 72 hours after surgery
measure: Length of hospital stay
timeFrame: Day 1 to day 7 after operation
measure: Surgical site infection
timeFrame: Within 96 hours after surgery
measure: Postoperative fever
timeFrame: Within 96 hours after surgery
measure: Patient discomfort from the ultrasound examination
timeFrame: Immediately after ultrasound examination
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Holy Family hospital, Nazareth
Study officials:
affiliation: Holy Family Hospital, Nazareth, Israel
name: Raed Salim, MD
role: STUDY_CHAIR
References:
citation: Massalha M, Faranish R, Romano S, Salim R. Decreased inferior vena cava diameter as an early marker in postpartum hemorrhage. Ultrasound Obstet Gynecol. 2022 Feb;59(2):234-240. doi: 10.1002/uog.23695. Epub 2022 Jan 18.
citation: Faustin D, Minkoff H, Schaffer R, Crombleholme W, Schwarz R. Relationship of ultrasound findings after cesarean section to operative morbidity. Obstet Gynecol. 1985 Aug;66(2):195-8.
citation: Naeiji Z, Sotudeh S, Keshavarz E, Naghshvarian N, Rahmati N. Risk factors and clinical significance of abdomino-pelvic free fluid after cesarean section: a prospective study. J Matern Fetal Neonatal Med. 2021 Jan;34(2):287-292. doi: 10.1080/14767058.2019.1605351. Epub 2019 May 15.
citation: Antonelli E, Morales MA, Dumps P, Boulvain M, Weil A. Sonographic detection of fluid collections and postoperative morbidity following Cesarean section and hysterectomy. Ultrasound Obstet Gynecol. 2004 Apr;23(4):388-92. doi: 10.1002/uog.1023.
citation: Hoppenot C, Tankou J, Stair S, Gossett DR. Sonographic evaluation for intra-abdominal hemorrhage after cesarean delivery. J Clin Ultrasound. 2016 May;44(4):240-4. doi: 10.1002/jcu.22289. Epub 2015 Aug 24.
citation: Dane C, Dane B, Cetin A, Yayla M. Sonographically diagnosed vault hematomas following vaginal hysterectomy and its correlation with postoperative morbidity. Infect Dis Obstet Gynecol. 2009;2009:91708. doi: 10.1155/2007/91708. Epub 2007 Feb 28.