Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)

Technical University of Munich

Status: Unknown

Conditions: Abdominal Pain

Treatments: Procedure: EUS; Procedure: EGD

Study type: Interventional

Funder types: Other

Identifiers

NCT01080690

01102

Details and patient eligibility

About

Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain.

Patients with acute right side abdominal pain will be randomized in one of two groups. In each group all examinations (sonography, gastroscopy, endosonography) will be performed. The study group only defines the order of the examinations. Abdominal sonography will always be performed before endoscopic procedures. In group 1, gastroscopy is first followed by endosonography. In group 2 endosonography is first followed by gastroscopy.

Two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis.

Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute right side abdominal pain
• willing participate study

Exclusion criteria

• acute disease
• malignancy
• other disease which might cause discomfort

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

240 participants in 2 patient groups

EGD

Active Comparator group

Description:

In this arm EGD will be performed before EUS

Treatment:

Procedure: EGD

EUS

Active Comparator group

Description:

In this arm, EUS will be performed before EGD.

Treatment:

Procedure: EUS