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Discomfort Score Identifies Painfulness During Unsedated Colonoscopy

A

Air Force Military Medical University of People's Liberation Army

Status

Completed

Conditions

Risk Factors Associated With Painful Colonoscopy

Study type

Observational

Funder types

Other

Identifiers

NCT03540173
KY20180128-1

Details and patient eligibility

About

Some patients felt no pain or only mild discomfort with the unsedated colonoscopy. However, unsedated colonoscopy was thought to be an option for some but not for all. If we could able to identify which patients at high risk for painful colonoscopy in preoperational stage, targeted administration of sedatives or special techniques to these patients would be an attractive option.

Full description

Here we prospectively collected the data during colonoscopy and investigated the possible risk factors associated with painful colonoscopy by using a step-wise multivariate regression model. Furthermore we developed a novel point score to predict whether the patients at high risk for painful colonoscopy and targeted offer an appropriate method of colonoscopy or with the aid of special techniques to help the completion of procedure.

Enrollment

1,220 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients who underwent unsedated colonoscopy

Exclusion criteria

  • (1) no bowel preparation or colon cleansing by enema only; (2) no need to reach cecum; (3) prior finding of severe colon stenosis or obstructing tumor; (4) history of colectomy; (5) unstable hemodynamics; (6) pregnant; (7) unable to give informed consent.

Trial design

1,220 participants in 2 patient groups

Training Cohort
Description:
In the training cohort, we evaluated the impact of patient-related factors on the pain during the colonoscopy. In univariatelogistic regression analysis, All factors associated with the pain during colonoscopy (p\<0.1) were included in multivariate analysis.
Validation group
Description:
The validation cohort was used to verify the intubation discomfort score.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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