Factors Associated With Pain During Unsedated Colonoscopy

A Novel Intubation Discomfort Score Identifies Patients Feeling Painful During Unsedated Colonoscopy

Colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the examination and giving analgesic agents were recommended in several guidelines. However, use of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only mild discomfort with the unsedated colonoscopy, routine administration of sedative or analgesic agents to all patients was considered as unnecessary. However, unsedated colonoscopy was thought to be an option for some but not for all, therefore a method to identify which patients at high risk for painful colonoscopy in preoperational stage is necessary.

Study Overview

• Status: Completed
• Conditions: Pain; Colonoscopy; Unsedated

• Study Type: Observational
• Enrollment (Actual): 607

Contacts and Locations

Study Locations

• China
  • Xi'an, China, 710032
    • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients of the training cohort were enrolled form Xijing Hospital of Digestive Diseases. The patients of the validation cohort were enrolled from the Shaanxi Second People's Hospital.

Description

Inclusion Criteria:

• aged 18-80 years
• underwent unsedated colonoscopy

Exclusion Criteria:

• no bowel preparation or colon cleansing by enema only
• no need to reach cecum
• prior finding of severe colon stenosis or obstructing tumor
• history of colectomy
• unstable hemodynamics
• pregnant
• unable to give informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
training; The training cohort was used to determine the influencing factors of the pain during the colonoscopy and establish the intubation discomfort score (IDS)
validation; The validation cohort was used to verify the IDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk factor associated with painful colonoscopy rate	Abdominal pain during the examination was evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)[14], and moderate or severe pain during the procedure was defined as a "painful colonoscopy"	2 hours

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): May 12, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: KY20163066-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No