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Is a Reporting System for Gastritis or Duodenitis (Modified Lanza Scale) Reproducible?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fook-Hong Ng, Ruttonjee Hospital
ClinicalTrials.gov Identifier:
NCT00852150
First received: February 25, 2009
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

The modified Lanza scale (Lanza FL, 1984) has been widely utilized to grade the degree of gastritis and duodenitis. However, the inter-rater or intra-rater reproducibility of this scale has never been validated. As a quality improvement program, it is important to study the reproducibility of the scale between different operators and the operators himself.

Method: During upper endoscopic examinations, one investigator performed the procedure and the second investigator look at the endoscopic image. The degree of gastritis and duodenitis is graded. The results of the grading are blinded to the other investigator.

The endoscopic video is stored for reassessment to determine the intra-rater reliability. The patient identifier is stored in serial number. The investigator will not retrieve the report of the first assessment during the second assessment.


Condition Phase
Gastritis
Duodenitis
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Reproducibility of Modified Lanza Scale for the Reporting of Gastritis and Duodenitis

Further study details as provided by Ruttonjee Hospital:

Primary Outcome Measures:
  • Kappa coefficient for the intra and inter-rater agreement [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

all patient undergoing upper endoscopy after informed consent is obtained

Criteria

All patients undergo upper endoscopy are included after written informed consent is obtained

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852150

Locations
China, Hong Kong
Ruttonjee Hospital
Wan Chai, Hong Kong, China
China
Ruttonjee Hospital
Hong Kong, China
Sponsors and Collaborators
Ruttonjee Hospital
Investigators
Principal Investigator: Fook Hong Ng, M.D. Department of Medicine, Ruttonjee Hospital
  More Information

No publications provided

Responsible Party: Fook-Hong Ng, SMO, Ruttonjee Hospital
ClinicalTrials.gov Identifier: NCT00852150     History of Changes
Other Study ID Numbers: HKEC 2008-083
Study First Received: February 25, 2009
Last Updated: June 5, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Ruttonjee Hospital:
gastritis
duodenitis
inter-rater reliability
 intra-rater reliablity
gastroscopy
duodenoscopy

Additional relevant MeSH terms:
Duodenitis
Gastritis
Enteritis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Duodenal Diseases
Intestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 16, 2013