Comparison of Colon Cleansing Quality Between the Setting of Colon Cleansing Room and the Standard Colon Preparation in a Community Base Setting -- a Prospective Randomized Controlled Trial

The quality of colon preparation plays a crucial role in colon cancer prevention, especially for right side colon. So far, colon cleansing is still not adequate in up to 10-30% colonoscopies and leads to increase risk of missed neoplasm.Recent literature on colonoscopy preparation revealed the dosage, timing and dietary restriction could influence colon preparation quality. Previous study demonstrated colon cleansing on the day of colonoscopy had better cleansing quality. However, the ideal colon preparation is not yet determined. the investigators herein consider the in-hospital setting of colon cleansing room can ensure better colon cleansing timing, colon preparation evaluation reliability and patient's compliance of colon cleansing. Therefore, the investigators design a prospective randomized controlled trial to compare cleansing quality between the setting of colon cleansing room and the standard colon preparation.

Study Overview

• Status: Completed
• Conditions: Colon Cleansing Level
• Intervention / Treatment: Procedure: colonoscopic examination in colon cleansing room

Detailed Description

The investigators prospectively enroll 130 adults that receive colonoscopy examination from Jan 1, 2014 to June 30, 2014. Written Inform consents are achieved before colonoscopy. All patients are randomly assigned to group A and group B. The group A is named as "the setting of colon cleansing room group". The group B is named as " the standard colon preparation group". The randomization was done by a study nurse who is well trained about the teaching course of bowel cleansing level evaluation, low residual diet education and preparation method. Demographic data is collected through questionnaire before colonoscopy. Diet restriction for two days with lower residual diet is well educated through a detail checklist. All patients receive a brief counselling session. The investigators outline the colon preparation instructions. The investigators also explain the rationale for colon preparation with a complete checklist and the picture of colon cleansing assessment. All patients in group B initiate the standard colon preparation with PEG-ELS made from two sachets of PEG (Klean-PrepTM, Norgine Ltd. Harefield, Middlesex, United Kingdom) dissolved in 2 L of water at 8:00 AM on the day of colonoscopy. All patients in group A drink two liter PEG-ELS in the colon cleansing room which is a in-hospital setting for colon preparation at 8:00 AM on the day of colonoscopy. The time interval in both group between colon preparation and colonoscopy is 3 to 5 hours. All colonoscopies are performed by two endoscopists in Jin-Shan Branch Hospital with an Olympus CF-260AL colonoscope (Olympus Optical Co. Ltd., Tokyo, Japan). All endoscopists were trained at National Taiwan University Hospital with at least eight hundred colonoscopy experience. The endoscopist follow the standard protocol to insert, withdraw and observation. Intramuscular injection of hyoscine butylbromide is done as antispasmodic if there is no contraindication. Complete colonoscopy is defined as reaching and taking a picture of the cecum. Endoscopists take pictures at every anatomical portion of colon including cecum, ascending colon, transverse colon, descending colon, sigmoid colon and rectum before and after fecal material is washed out. Theendoscopist also record all of the colonoscopy examination as video files. All colonoscopists are asked to take at least thirty pictures during whole colonoscopy examination. Colon cleansing quality is scored by Boston Bowel Preparation Quality Scale. The scale is applied to each colon segment including right colon (R), middle colon (T) and the rectosigmoid colon(L). The score is calculated by adding the 0 to 3 ratings for each colon section. Electronic files of endoscopic pictures without lesion presentation and edited videos were reviewed by all endoscopist. All the detected adenomas during both study group are recorded and stored as electronic files and video including location, size, morphology and endoscopic diagnosis. The primary endpoint of study is to compare the Boston Bowel Preparation Quality Scale between the two study group. The secondary endpoint is to compare the average number of adenoma detection between the two study group. Sample size is estimated by the average number of adenoma detected (1.0 lesions per subject in standard preparation group, SD 1.0 and 1.5 lesions per subject in hospital preparation group, SD 1.0) according to a previous study in National Taiwan University Hospital and the pilot study in National Taiwan University Hospital , Jin Shan Branch , more than 80% power by enrolling 65 subjects in each group are achieved ( t test, α error of 0.05).

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 208
    • National Taiwan University Hospital, Jin Shan branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who are indicated and willing to recieve colonoscopic examination

Exclusion Criteria:

• 1. previous history of colorectal surgery
• 2. toxic colitis
• 3. pregnancy woman
• 4. acute myocardial infarction or unstable angina.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: colon cleansing room group; All patients in colon cleansing room group drink two liter PEG-ELS in the colon cleansing room which is a in-hospital setting for colon preparation at 8:00 AM on the day of colonoscopy.	Procedure: colonoscopic examination in colon cleansing room; All patients drink two liter PEG-ELS in the colon cleansing room which is a in-hospital setting for colon preparation at 8:00 AM on the day of colonoscopy.
Placebo Comparator: standard colon preparation group; All patients in the standard colon preparation groupinitiate the standard colon preparation with PEG-ELS made from two sachets of PEG (Klean-PrepTM, Norgine Ltd. Harefield, Middlesex, United Kingdom) dissolved in 2 L of water at 8:00 AM on the day of colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Bowel Preparation Quality Scale	The scale is applied to each colon segment including right colon (R), middle colon (T) and the rectosigmoid colon(L). The score is calculated by adding the 0 to 3 ratings for each colon section.	eight months

Secondary Outcome Measures

Outcome Measure	Time Frame
the average detected adenoma number	eight months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	Side effect of PEG-ELS will be monitored.	eight months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: tsai kun feng, master, National Taiwan University Hospital Jin-Shan branch

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: colon preparation
• Other Study ID Numbers: 201310073RINA