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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02422680
Other study ID # AalborgH
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 23, 2015
Est. completion date December 31, 2019

Study information

Verified date July 2019
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The study aim is to investigate factors associated with patient satisfaction during a colonoscopy.


Description:

The study aim to capture key quality indicators and patient satisfaction for 800 patients referred for a colonoscopy at Aalborg University Hospital. The patient population is mix of screening and non-screening colonoscopies seen at our out-patient clinic.

Each Colonoscopy is registered using a specially designed registration form and a more detailed form relating to the colonoscopy itself. The data collected includes: The Colonoscopist endoscopy experience and education, Medicine use, Colonoscopy duration, Unadjusted Caecum Intubations rate, Polyp detection rate, Polyps removed, Cancer detection rate and Nurse assisted Gloucester Comfort score.

Patient level data were recorded using a questionaire with 6 questions regarding satisfaction, pain, discomfort etc on a 10 cm analog scale.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2019
Est. primary completion date September 30, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients referred to colonoscopy at the out-patient clinic at Aalborg University department.

Exclusion Criteria:

- Rejection to fill out questionaire.

- Patents referred to AVA (advanced endoscopy unit) were excluded as the are not comparable to regular colonoscopies. Most patients are referred to AVA for specific endoscopy treatments such as large polyp removals etc.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
No intervention, purely observational.
No intervention is made other than following existing guidelines for colonoscopy. Further treatment and/or renewed colonoscopy in case of positive findings follows existing guidelines. The group is used only used to collect quality assurance data.

Locations

Country Name City State
Denmark NordSim, Aalborg University Hospital Aalborg

Sponsors (2)

Lead Sponsor Collaborator
Aalborg University Hospital Nordsim

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Chartier L, Arthurs E, Sewitch MJ. Patient satisfaction with colonoscopy: a literature review and pilot study. Can J Gastroenterol. 2009 Mar;23(3):203-9. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Satisfaction Each patient were given a questionaire with 6 questions answering satisfaction, pain, discomfort etc on a 10 cm analog scale. 1 day
Secondary Nurses perception of patients' pain Nurse assisted Gloucester Comfort score 1 day
Secondary Patient Pain (own Perception) 10 cm analog scale 1 day
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