NCT02422680

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2015

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

April 10, 2015

Last Update Submit

July 2, 2019

Conditions

Keywords

Quality assuranceCaecum intubation ratePatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Nurses perception of patients' pain

    1 day

  • Patient Pain (own Perception)

    1 day

Study Arms (1)

Patients referred to a colonoscopy

A min. of 800 patients referred to colonoscopy at Aalborg University Hospital. The 800 patients are from the out patient clinic. A mix of screening and non-screening patients.

Procedure: No intervention, purely observational.

Interventions

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.

Patients referred to a colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to colonoscopy at the out patient clinic at Aalborg University department. All patients deemed fit to for at colonoscopy at the outpaient clinic were included. The patient population is a mix of screening and non-screening patients. The study begins in april 2015.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NordSim, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related 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. doi: 10.1155/2009/903545.

    PMID: 19319384BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsPatient Satisfaction

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Lasse Pedersen, m.d.

    Aalborg University Hospital, Surgical Department.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.-student

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 21, 2015

Study Start

March 23, 2015

Primary Completion

September 30, 2015

Study Completion

December 31, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations