Discomfort Score Identifies Painfulness During Unsedated Colonoscopy

May 16, 2018 updated by: Yanglin Pan, Air Force Military Medical University, China

A New Intubation Discomfort Score Identified Patients' Painfulness During Unsesated Colonoscopy

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital of Digestive Diseases
      • Xi'an, Shaanxi, China, 710032
        • Shaanxi Second People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The anxiety status
Time Frame: 1 year
Hospital Anxiety and Depression Scale (HAD)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal pain
Time Frame: 1 year
Abdominal pain evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

October 10, 2017

Study Completion (Actual)

October 10, 2017

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • KY20180128-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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