Impacts of Inspection During Instrument Insertion on Colonoscopy Quality

Colon Polyp Clinical Trial

Official title:

Impacts of Inspection During Instrument Insertion on Colonoscopy Quality: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444090
• Other study ID #: EGH-2017-1
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2019
• Source: Evergreen General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Polyp

Intervention

Procedure:
• Colon polypectomy
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.

Locations

Country	Name	City	State
Taiwan	Evergreen General Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Evergreen General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During procedure, approximately one hour
Secondary	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.	During procedure, approximately one hour