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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01156506
Other study ID # AKD02
Secondary ID
Status Completed
Phase N/A
First received June 30, 2010
Last updated December 11, 2012
Start date February 2010
Est. completion date April 2010

Study information

Verified date December 2012
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Observational

Clinical Trial Summary

The study seeks to gain knowledge about new and of alternative ways of organizing ostomy training based on informants' own experiences of life with a stoma.

The study is designed and conducted as qualitative focus group interviews with three different groups of patients with enterostomas (5-8 in each group): a) people with permanent enterostoma due to cancer, 2) people with permanent enterostoma due to non-cancer and 3) people with a temporary ileostomy.


Description:

The study is investigating the perspective of the patients who have actually experienced having surgery and living with an enterostoma.

By applying this method it is possible to gain access and in depth knowledge of complex issues including sensitive data. The dialogue with peers can lead to experiments and associations which might stimulate the informants to produce new insights within the individual and in the group.

The interviews will be transcribed in full and analyzed with qualitative content analysis with a phenomenological and hermeneutical approach


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with permanent enterostoma due to cancer.

- Patients with permanent enterostoma due to other causes.

- Patients with temporary ileostomy.

Exclusion Criteria:

- Patients with severe mental disorders.

- Patients who do not communicate in Danish.

- Patients with severe hearing impairment.

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Educational elements and themes that will optimize rehabilitation and patient education Illumination and discussion of informantsĀ“ perspective on rehabilitation and patient education will up until 10 months from interview No
Secondary Identification of strategies for improving quality of life Illumination and discussion of informants perspective on the influence of an enterostoma on their lives up until 10 months from interview No
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