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Factors Associated With Pain During Unsedated Colonoscopy

A

Air Force Military Medical University of People's Liberation Army

Status

Completed

Conditions

Colonoscopy
Pain
Unsedated

Study type

Observational

Funder types

Other

Identifiers

NCT03420612
KY20163066-1

Details and patient eligibility

About

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.

Enrollment

607 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

607 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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