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Discomfort Score Identifies Painfulness During Unsedated Colonoscopy

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ClinicalTrials.gov Identifier: NCT03540173
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Air Force Military Medical University, China

Study Description
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Brief Summary:
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.

Condition or disease
Risk Factors Associated With Painful Colonoscopy

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 1220 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A New Intubation Discomfort Score Identified Patients' Painfulness During Unsesated Colonoscopy
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : October 10, 2017
Actual Study Completion Date : October 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Groups and Cohorts
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Group/Cohort
Training Cohort
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
The validation cohort was used to verify the intubation discomfort score.


Outcome Measures
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Primary Outcome Measures :
  1. The anxiety status [ Time Frame: 1 year ]
    Hospital Anxiety and Depression Scale (HAD)


Secondary Outcome Measures :
  1. Abdominal pain [ Time Frame: 1 year ]
    Abdominal pain evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients were prescribed polyethylene glycol electrolyte for bowel preparation according to the preference of physicians. They were asked to drink the first 2L of PEG4000e at19:00-20:00 PM on the night before colonoscopy within 2 hours. Then, on the day of the examination, patients were asked to take the remaining 2L 5 hours before the procedure. Patients were encouraged to drink more clear liquids after purgatives for adequate hydration before colonoscopy. In addition, patients were instructed to have a regular meal for lunch and only liquid diets for dinner the day before the operation.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540173


Locations
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China, Shaanxi
Shaanxi Second People's Hospital
Xi'an, Shaanxi, China, 710032
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Air Force Military Medical University, China
More Information
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Responsible Party: Yanglin Pan, Associated professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT03540173    
Other Study ID Numbers: KY20180128-1
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No