Clinical trial NCT03444090: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyp
Colon Adenoma
Lead sponsor: Evergreen General Hospital, Taiwan
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 428
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Detection of at Least One Adenoma Per Procedure
timeFrame: During procedure, approximately one hour
Secondary outcomes:
measure: Mean Colon Adenoma Per Colonoscopy
timeFrame: During procedure, approximately one hour
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Evergreen General Hospital
Study officials:
affiliation: Evergreen General Hospital
name: Chiliang Cheng
role: PRINCIPAL_INVESTIGATOR
References:
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.