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

NCT ID: NCT06953141

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2026-07-15

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.

Conditions

Post-Operative Hematoma at Operative Site (Diagnosis); Post-Operative Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

Abdominal and transvaginal ultrasound

Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Holy Family Hospital, Nazareth, Israel

OTHER

Sponsor Role: lead

Responsible Party

Raed Salim, MD

Head of Obstetrics and Gynecology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raed Salim, MD

Role: STUDY_CHAIR

Holy Family Hospital, Nazareth, Israel

Locations

Holy Family hospital, Nazareth

Nazareth, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Raed Salim, MD

Role: CONTACT

r.salim@hfhosp.org

+972544986960

Reem Younis, MD

Role: CONTACT

reemyounis010@gmail.com

+972528328002

Facility Contacts

Reem Younis, MD

Role: primary

Reemyounis010@gmail.com

+972528328002

References

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.

Reference Type: BACKGROUND

PMID: 34076923 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3895070 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30957592 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15065191 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26302357 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17485823 (View on PubMed)

Other Identifiers

308-2025-HFH

Identifier Type: -

Identifier Source: org_study_id