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Completed

NCT Number: NCT02443480

Development and Validation of the Saint Paul's Endoscopy Comfort Scale (SPECS) for Colonoscopy and Upper Endoscopy

The investigators created the St. Paul's Endoscopy Comfort Score (SPECS) which includes the frequency of verbal cues, body positioning and anxiety levels with descriptions for each of the variables. Our objective is to compare the SPECS, NAPCOMs, NPAT and GS amongst different observers and to determine any correlation with patient satisfaction.

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Key information

Conditions

Patient Comfort

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

About this study

Colonoscopy is used for the diagnosis and treatment of colonic lesions as well as screening and follow up of patients at risk of developing colorectal cancer. With the increasing demand for colonoscopies, the number of procedures performed in recent years has increased dramatically (Bjorkman & Popp Jr., 2006). Given that performance of a high quality colonoscopy is dependent on the expertise and technical skills of the endoscopist, quantitative and reliable methods for measurement of the quality of colonoscopy are needed. Although other colonoscopy quality indicators, such as adenoma detection rate, have been studied comprehensively (Rex, et al., 2006), patient comfort as a measure of endoscopic quality performance has not been thoroughly assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 19 years or older
  • Outpatients referred to Saint Paul's Hospital for colonoscopy and upper endoscopy
  • Capable of reading and understanding English

Exclusion criteria

  • Patients who undergo colonoscopy and upper endoscopy in the same appointment

Treatment and study plan

Primary outcomes

  1. Inter-observer reliability

    Time frame: 15-30 minutes

    To determine the inter-observer reliability for the SPECS amongst observers and the different comfort scores, NAPCOMS, GS and NPAT.

  2. Correlation with patient's reported pain

    Time frame: 10-15 minutes

    To determine the correlation of SPECS, NAPCOMS, GS and NPAT with post-procedure patient reported pain and satisfaction controlling for sedation.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Do You Have Your SPECS in Order? Development and Validation of the Saint Paul's Endoscopy Comfort Scale (SPECS) for Colonoscopy and Upper Endoscopy

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 13, 2015
Registry last updated
Oct 26, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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