Factors Associated With Pain During Unsedated Colonoscopy

NCT ID: NCT03420612

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

607 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-02

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colonoscopy Unsedated Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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training

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

No interventions assigned to this group

validation

The validation cohort was used to verify the IDS

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, , China

Site Status

Countries

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China

Other Identifiers

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KY20163066-1

Identifier Type: -

Identifier Source: org_study_id

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