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

This study is currently recruiting participants.

Verified August 2010 by Ruttonjee Hospital

First Received on February 25, 2009. Last Updated on August 6, 2010 History of Changes

Sponsor:	Ruttonjee Hospital
Information provided by:	Ruttonjee Hospital
ClinicalTrials.gov Identifier:	NCT00852150

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 IV

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
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (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

Contacts

Contact: Fook Hong Ng, M.D.

852- 22911743

ngfhong@hkucc.hku.hk

Locations

China, Hong Kong
Ruttonjee Hospital	Completed
Wan Chai, Hong Kong, China
China
Ruttonjee Hospital	Recruiting
Hong Kong, China
Contact: FH Ng, MD 22911743

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:	Dr Fook Hong Ng, Ruttonjee Hospital
ClinicalTrials.gov Identifier:	NCT00852150 History of Changes
Other Study ID Numbers:	HKEC 2008-083
Study First Received:	February 25, 2009
Last Updated:	August 6, 2010
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 February 09, 2012