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Impacts of Inspection During Instrument Insertion on Colonoscopy Quality

Primary Purpose

Colon Polyp, Colon Adenoma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Colon polypectomy
Sponsored by
Evergreen General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Polyp

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 45 years or older.
  • Agree to participate the study and provide a written informed consent

Exclusion Criteria:

  • Previous surgical resection of the colon or rectum
  • Inflammatory bowel disease
  • Polyposis syndrome
  • Previously incomplete colonoscopy
  • Obstructive lesions of colon
  • Inadequate bowel preparation, defined as Boston Bowel Preparation Scale score of 0 or 1 in any colon segment
  • Gastrointestinal bleeding
  • Allergy to fentanyl or midazolam
  • American Society of Anesthesiology classification of physical status 3 or higher
  • Mental retardation
  • Pregnancy
  • Refusal to provide a written informed consent

Sites / Locations

  • Evergreen General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insertion/withdrawal colon polypectomy

Withdrawal colon polypectomy

Arm Description

For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size <10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size >10 mm will be performed only during withdrawal of the scope.

For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.

Outcomes

Primary Outcome Measures

Percentage of Participants With Detection of at Least One Adenoma Per Procedure
Colon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.

Secondary Outcome Measures

Mean Colon Adenoma Per Colonoscopy
Mean colon adenoma per procedure is defined as the total number of adenomas detected divided by the number of colonoscopies.

Full Information

First Posted
February 10, 2018
Last Updated
February 7, 2019
Sponsor
Evergreen General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03444090
Brief Title
Impacts of Inspection During Instrument Insertion on Colonoscopy Quality
Official Title
Impacts of Inspection During Instrument Insertion on Colonoscopy Quality: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evergreen General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Small colon polyps which are found during colonoscopy insertion are sometimes difficult to find during withdrawal and thus missed. The investigators aim to evaluate the differences of colon polyp/adenoma detection rates of patients undergoing additional inspection and polypectomy during insertion as compared to the patients undergoing traditional practice of careful inspection and polypectomy performed entirely during withdrawal of colonoscopy.
Detailed Description
Participants will be randomly assigned by a research assistant, by using a computer-generated randomization sequence to undergo colonoscopy with either inspection and polypectomy during both insertion and withdrawal of colonoscope (study group) or inspection and polypecotmy entirely during withdrawal of colonoscope (control group). Randomization will be done via concealed allocation with a sealed envelope that designate study group or control group. Colonoscopies will be performed by two experienced investigators by using a standard colonoscopy (CF-Q260AI or CF-Q260AL; Olympus Medical Systems Corp., Tokyo, Japan). All procedures are performed under moderate conscious sedation with fentanyl (United Biomedical, Taipei, Taiwan) and midazolam (Dormicum; Roche Pharmaceuticals, Basel, Switzerland) according to the current guidelines. Carbon dioxide insufflation is used for all endoscopic procedures. All participants receive 3-L polyethylene glycol (PEG; Klean-Prep, Helsinn Birex Pharmaceuticals Ltd., Dublin, Ireland) for bowel preparation. A split-dose of the PEG preparation is provided. The level of colon cleansing is prospectively evaluated with the Boston Bowel Preparation Scale score. For participants assigned into the study group, the colonic lumen is washed with saline and the fluid and debris are suctioned as the instrument is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the colonic mucosa is performed with adequate luminal insufflations during both the insertion and withdrawal phases. Polyp size is determined by comparison with open colonoscopic biopsy forceps pushed against the polyp or, in some cases of pedunculated polyp by direct measurement after retrieval. Polyps with size <10mm are removed as they are identified on insertion and withdrawal. Polyps with size ≥10mm are removed only during withdrawal. For participants assigned into the control group, deliberate mucosal inspection and polyp removal are performed exclusively on instrument withdrawal. During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum. If a polyp is found during insertion, investigators are instructed to make a mental note of it and find it during withdrawal for polypectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp, Colon Adenoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
428 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insertion/withdrawal colon polypectomy
Arm Type
Experimental
Arm Description
For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size <10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size >10 mm will be performed only during withdrawal of the scope.
Arm Title
Withdrawal colon polypectomy
Arm Type
Active Comparator
Arm Description
For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
Intervention Type
Procedure
Intervention Name(s)
Colon polypectomy
Intervention Description
For participants assigned into the experimental group, colon lumen is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both the insertion and withdrawal phases. Colon polyps with size <10 mm are removed as they are identified on insertion and withdrawal. Polyps with size >10 mm are removed only during withdrawal. For participants assigned into the control group, deliberate inspection and polyp removal are performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
Primary Outcome Measure Information:
Title
Percentage of Participants With Detection of at Least One Adenoma Per Procedure
Description
Colon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.
Time Frame
During procedure, approximately one hour
Secondary Outcome Measure Information:
Title
Mean Colon Adenoma Per Colonoscopy
Description
Mean colon adenoma per procedure is defined as the total number of adenomas detected divided by the number of colonoscopies.
Time Frame
During procedure, approximately one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 45 years or older. Agree to participate the study and provide a written informed consent Exclusion Criteria: Previous surgical resection of the colon or rectum Inflammatory bowel disease Polyposis syndrome Previously incomplete colonoscopy Obstructive lesions of colon Inadequate bowel preparation, defined as Boston Bowel Preparation Scale score of 0 or 1 in any colon segment Gastrointestinal bleeding Allergy to fentanyl or midazolam American Society of Anesthesiology classification of physical status 3 or higher Mental retardation Pregnancy Refusal to provide a written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiliang Cheng
Organizational Affiliation
Evergreen General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evergreen General Hospital
City
Taoyuan
ZIP/Postal Code
320
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30675926
Citation
Cheng CL, Kuo YL, Liu NJ, Tang JH, Fan JW, Lin CH, Tsui YN, Lee BP, Hung HL. Comparison of polyp detection during both insertion and withdrawal versus only withdrawal of colonoscopy: A prospective randomized trial. J Gastroenterol Hepatol. 2019 Aug;34(8):1377-1383. doi: 10.1111/jgh.14613. Epub 2019 Feb 27.
Results Reference
derived

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Impacts of Inspection During Instrument Insertion on Colonoscopy Quality

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