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Impacts of Inspection During Instrument Insertion on Colonoscopy Quality

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03444090
Enrollment
428
Registered
2018-02-23
Start date
2017-10-02
Completion date
2018-06-30
Last updated
2019-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Adenoma, Colon Polyp

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.

Interventions

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.

Sponsors

Evergreen General Hospital, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Detection of at Least One Adenoma Per ProcedureDuring procedure, approximately one hourColon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.

Secondary

MeasureTime frameDescription
Mean Colon Adenoma Per ColonoscopyDuring procedure, approximately one hourMean colon adenoma per procedure is defined as the total number of adenomas detected divided by the number of colonoscopies.

Countries

Taiwan

Participant flow

Participants by arm

ArmCount
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.
211
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.
210
Total421

Baseline characteristics

CharacteristicInsertion/Withdrawal Colon PolypectomyTotalWithdrawal Colon Polypectomy
Age, Continuous57.6 years
STANDARD_DEVIATION 8.5
57.9 years
STANDARD_DEVIATION 8.5
58.2 years
STANDARD_DEVIATION 8.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
211 Participants421 Participants210 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Taiwan
211 participants421 participants210 participants
Sex: Female, Male
Female
112 Participants223 Participants111 Participants
Sex: Female, Male
Male
99 Participants198 Participants99 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2110 / 210
other
Total, other adverse events
0 / 2110 / 210
serious
Total, serious adverse events
0 / 2110 / 210

Outcome results

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.

Time frame: During procedure, approximately one hour

ArmMeasureValue (MEAN)
Insertion/Withdrawal Colon PolypectomyPercentage of Participants With Detection of at Least One Adenoma Per Procedure63.7 percentage of participants
Withdrawal Colon PolypectomyPercentage of Participants With Detection of at Least One Adenoma Per Procedure68.1 percentage of participants
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.

Time frame: During procedure, approximately one hour

ArmMeasureValue (MEAN)Dispersion
Insertion/Withdrawal Colon PolypectomyMean Colon Adenoma Per Colonoscopy1.6 adenomas/colonoscopyStandard Deviation 2
Withdrawal Colon PolypectomyMean Colon Adenoma Per Colonoscopy1.9 adenomas/colonoscopyStandard Deviation 2.4

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026