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N/A N=428 Randomized Single-blind Treatment

Impacts of Inspection During Instrument Insertion on Colonoscopy Quality

Colon Polyp · Colon Adenoma

Enrolled (actual)
428
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Percentage of Participants With Detection of at Least One Adenoma Per Procedure — 63.7; 68.1 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Colon polypectomy (Procedure)
Age
Adult, Older Adult · 45+ yrs
Sex
All
Sponsor
Evergreen General Hospital, Taiwan
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Detection of at Least One Adenoma Per Procedure
63.7; 68.1
SECONDARY
Mean Colon Adenoma Per Colonoscopy
1.6; 1.9

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03444090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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