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Recruiting NCT06953141

Ultrasound for Assessment of Intra-Abdominal Blood Loss After Gynecological Surgery

— Observational Post-Operative Hematoma at Operative Site (Diagnosis) Post-Operative Hemorrhage

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What is being studied
The protocol lists: Ultrasound.
Who it may be relevant to
Registry conditions: Post-Operative Hematoma at Operative Site (Diagnosis), Post-Operative Hemorrhage. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Diagnostic test Ultrasound
    Transabdominal and transvaginal imaging will be performed to eligible women following gynecological surgery within 24 - 48 hours.

Primary outcome measures

  • Incidence of intra-abdominal free fluid [Time frame: Within 24-48 hours after surgery]
Secondary outcome measures (9)
  • Volume of intra-abdominal fluid [Time frame: Within 24-48 hours after surgery]
  • Presence and size of pelvic hematoma [Time frame: Within 24-48 hours after surgery]
  • Inferior vena cava (IVC) diameter and collapsibility index [Time frame: Within 24-48 hours after surgery]
  • Hemoglobin drop [Time frame: Within 24-48 hours after surgery]
  • Need for blood transfusion [Time frame: Within 72 hours after surgery]
  • Length of hospital stay [Time frame: Day 1 to day 7 after operation]
  • Surgical site infection [Time frame: Within 96 hours after surgery]
  • Postoperative fever [Time frame: Within 96 hours after surgery]
  • Patient discomfort from the ultrasound examination [Time frame: Immediately after ultrasound examination]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Israel · 1 center
  • Holy Family hospital, Nazareth — Nazareth

Publications

  • 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. PMID 34076923
  • 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. PMID 3895070
  • 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. PMID 30957592
  • 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. PMID 15065191
  • 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. PMID 26302357
  • 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. PMID 17485823

Identifiers

NCT: NCT06953141 · 308-2025-HFH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗