PoCUS Diagnostic Accuracy for Fecal Impaction in the Emergency Department: A Prospective Study

NCT06333106 | Completed

• 1 other identifier: FICUS - 2024/16FEV/077
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 6

Brief Summary

Many medical and paramedical specialties regularly use point-of-care ultrasound (PoCUS) in clinical practice. The diagnosis of fecal impaction is quite common in the elderly living in nursing homes with a prevalence of 47.3%. Fecal impaction remains a major source of morbidity, while its etiology is often multifactorial and its diagnosis challenging. Current recommendations for the diagnosis of fecal impaction support the use of plain abdominal x-rays. PoCUS is a non-irradiating procedure and a clinical diagnostic tool that can be used in a variety of ways during abdominal examinations. Most scientific societies encourage the use of PoCUS to respond to a specific clinical question rather than to provide a diagnosis, which is usually confirmed by conventional ultrasound. However, the combination of physical examination and PoCUS may improve the diagnostic approach. This multicentric prospective study protocol aims to evaluate the diagnostic accuracy of PoCUS in patients aged 75 years or older with suspected fecal impaction in the emergency department compared with plain abdominal x-ray (or abdominal CT scan if required as part of the emergency department investigations).

Conditions

Fecal Impaction of Colon

Outcome Measures

Primary Outcomes (1)

• Evaluation of the diagnostic value of clinical ultrasound in the diagnosis of fecal impaction in the emergency room

  Sensitivity and specificity of PoCUS in the diagnosis of fecal impaction compared to abdominal radiography (or abdominal CT) as a diagnostic reference tool with likelihood ratios and positive and negative predictive values.

  2 hours

Secondary Outcomes (3)

• Influence of BMI on the diagnosis of fecal impaction at PoCUS

  2 hours

• Influence of bladder repletion on the diagnosis of fecal impaction using PoCUS

  2 hours

• Influence of patient echogenicity on the diagnosis of fecal impaction using PoCUS

  2 hours

Study Arms (1)

Patient suspected to suffer from fecal impaction

OTHER

Any patients aged 75 years or older coming to the ED and for whom the emergency physician suspects fecal impaction.

Other: POCUS diagnostic value

Interventions

POCUS diagnostic value OTHER

Evaluation of the diagnostic value of clinical ultrasound in the diagnosis of fecal impaction in the emergency room

Patient suspected to suffer from fecal impaction

Eligibility Criteria

• Age: 75 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients 75 years or older
• Patient for whom the clinician in charge indicates that an abdominal x-ray should be performed to check for the presence of a fecal impaction
• Informed consent, read and signed by the patient or their legal representative

You may not qualify if:

• Patient or legal representative not understanding one of the consent languages (French, Dutch and English)
• Reasons making suprapubic ultrasound impossible

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Grand Hôpital de Charleroi: collaborator
• Jolimont: collaborator
• University of Liege: collaborator
• Clinique Saint Pierre Ottignies: collaborator
• Clinique Saint-Jean, Bruxelles: collaborator

Study Sites (6)

Clinique Saint-Jean, Bruxelles

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

Location

Jolimont

La Louvière, 7100, Belgium

Location

Université de Liège

Liège, 4000, Belgium

Location

Clinique Saint Pierre Ottignies

Ottignies-Louvain-la-Neuve, 1340, Belgium

Location

Related Publications (16)

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• Dupriez F, Tollet J, Nely H, Steenebruggen F, Peyskens L, Marissiaux L, Germeau B, Collard A, Mordant C, Thoma M, Penaloza A, de Castro BR. Point-of-care ultrasound diagnostic accuracy for fecal impaction in the emergency department: a prospective study. Intern Emerg Med. 2025 Nov 3. doi: 10.1007/s11739-025-04150-8. Online ahead of print.

  PMID: 41182496 DERIVED

Related Links

• Point of care ultrasound use by Registered Nurses and Nurse Practitioners in clinical practice: An integrative review

Study Officials

• Andrea Penaloza, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: May 2, 2024
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6)