Discomfort Score Identifies Painfulness During Unsedated Colonoscopy

Risk Factors Associated With Painful Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540173
• Other study ID #: KY20180128-1
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: October 10, 2017

Study information

• Verified date: May 2018
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1220
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Risk Factors Associated With Painful Colonoscopy

Locations

Country	Name	City	State
China	Shaanxi Second People's Hospital	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The anxiety status	Hospital Anxiety and Depression Scale (HAD)	1 year
Secondary	Abdominal pain	Abdominal pain evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)	1 year