Impacts of Inspection During Instrument Insertion on Colonoscopy Quality

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?

NCT01035775

Colorectal Cancer Colorectal Polyps

COMPLETED NA

9 Minutes for Colonoscopy Withdrawal

NCT03399045

Colon Polyps Colorectal Adenomas

COMPLETED NA

Adenoma Detection by Polypectomy During Both Insertion and Withdrawal

NCT01925833

Adenoma of Large Intestine

COMPLETED NA

Does Inspection of Colonic Mucosa During Insertion Improve Adenoma Detection?

NCT03254030

Adenoma Colon Serrated Adenoma

COMPLETED NA

9 Minutes for Tandem Colonoscopy Withdrawal

NCT04797065

Colon Polyp Colorectal Adenoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Polyp Colon Adenoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Insertion/withdrawal colon polypectomy

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.

Group Type EXPERIMENTAL

Colon polypectomy

Intervention Type PROCEDURE

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.

Withdrawal colon polypectomy

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.

Group Type ACTIVE_COMPARATOR

Colon polypectomy

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes