NCT01080690

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 4, 2010

Status Verified

February 1, 2010

Enrollment Period

5 months

First QC Date

January 27, 2010

Last Update Submit

March 3, 2010

Conditions

Abdominal Pain

Keywords

endosonography, right side abdominal painEndosonography (diagnostic value in right side abdominal pain)

Outcome Measures

Primary Outcomes (1)

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

    within the first week of complaints

Secondary Outcomes (1)

  • Calculate the time and cost savings and number of procedures for endosonography alone versus the combined approach of abd. sonography, gastroscopy and endosonography.

    one year

Study Arms (2)

EGD

ACTIVE COMPARATOR

In this arm EGD will be performed before EUS

Procedure: EGD

EUS

ACTIVE COMPARATOR

In this arm, EUS will be performed before EGD.

Procedure: EUS

Interventions

EGDPROCEDURE

In this arm EGD will be performed before EUS.

Also known as: EGD: A standard diagnostic EGD will be performed., EUS: A standard diagnostic EUS will be performed.
EGD
EUSPROCEDURE

In this arm EUS will be performed before EGD.

EUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute right side abdominal pain
  • willing participate study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum r.d. Isar, Technical University Munich

Munich, Germany

RECRUITING

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Alexander Meining, Prof.

    II Med Dep, TU Munich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentin Becker, Dr.

CONTACT

+49 89 41400valentin.becker@lrz.tum.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2010

First Posted

March 4, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

March 4, 2010

Record last verified: 2010-02

Locations

DE(1)