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OpenTrials
Completed

NCT Number: NCT03540173

Discomfort Score Identifies Painfulness During Unsedated 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.

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Key information

Conditions

Risk Factors Associated With Painful Colonoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaanxi Second People's Hospital, Xi'an, Shaanxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The anxiety status

    Time frame: 1 year

    Hospital Anxiety and Depression Scale (HAD)

Secondary outcomes

  1. Abdominal pain

    Time frame: 1 year

    Abdominal pain evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 30, 2018
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.