A comparison study between Leaser and LED endoscopy in colonic mucosa

Not Applicable

• Conditions: lcerative colitis; Ulcerative colitis, Inflammatory Bowel Disease; D003093

• Registration Number: JPRN-jRCTs052200073
• Lead Sponsor: Takagi Tomohisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1) The ulcerative colitis (UC) patients with extensive type or left-sided type who was diagnosed using clinical, endoscopic, and histologic findings
2) The UC patients who need the colonoscopy for evaluation of mucosal healing or surveillance for dysplasia or colorectal associated cancer
3) The UC patients with clinical remission status (as defined by Lichitiger index less than 4)
4) Age more than 20 years and less than 80
5) Informed consent was obtained from all enrolled UC patients

Exclusion Criteria

1) The ulcerative colitis (UC) patients with proctitis type
2) The UC patients with a history of complications on colonoscopy
3) The UC patients who are already undergoing or have undergone chemotherapy or radiation therapy for a known neoplastic disease
4) The UC patients with any of the following complications;
i)Infectious enteritis
ii)Colorectal cancer
5) The UC patients with drug allergies to the pretreatment drug for colonoscopy
6) The UC patients who needs a legal representative because of any difficulties to obtain informed consent
7) The UC patients who are considered to be ineligible by the chief investigator and subinvestigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The evaluation of colonic mucosa by LCI classification

Secondary Outcome Measures

Name	Time	Method
1) The evaluation of colonic mucosa by Mayo endscopic subscore (MES)<br>2) The evaluation of colonic mucosa by Ulcerative Colitis Endoscopic Index of Severity (UCEIS)<br>3) The evaluation of colonic mucosa by Munsell color system<br>4) The evaluation of colonic mucosa by L*a*b* color system<br>5) Appearance of adverse events