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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00852150
First Posted: February 26, 2009
Last Update Posted: June 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fook-Hong Ng, Ruttonjee Hospital
  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 Fook-Hong Ng, Ruttonjee Hospital:

Primary Outcome Measures:
  • Kappa coefficient for the intra and inter-rater agreement

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fook-Hong Ng, SMO, Ruttonjee Hospital
ClinicalTrials.gov Identifier: NCT00852150     History of Changes
Other Study ID Numbers: HKEC 2008-083
First Submitted: February 25, 2009
First Posted: February 26, 2009
Last Update Posted: June 6, 2012
Last Verified: June 2012

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

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