Quality of Life in Patients With Rectal Cancer Receiving Total Mesorectal Excision With or Without Stoma
NCT ID: NCT03487484
Last Updated: 2020-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
5 participants
OBSERVATIONAL
2018-03-22
2020-03-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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With protective stoma
Patients in which intraoperatively the decision was made to add a protective stoma (following a risk algorithm) to total mesorectal excision. In patients quality of life, the Gastrointestinal Quality of Life Index (GIQLI) questionnaire, Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied.
Quality of Life Questionnaire for gastrointestinal tract
To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
Quality of Life Questionnaire
To assess quality of life, the SF-36 questionnaire will be applied
Faecal Incontinence Score
To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied
No stoma
Patients in which intraoperatively the decision was made to refrain from adding a protective stoma (following a risk algorithm) to total mesorectal excision.
In patients quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index), Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied.
Quality of Life Questionnaire for gastrointestinal tract
To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
Quality of Life Questionnaire
To assess quality of life, the SF-36 questionnaire will be applied
Faecal Incontinence Score
To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied
Interventions
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Quality of Life Questionnaire for gastrointestinal tract
To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
Quality of Life Questionnaire
To assess quality of life, the SF-36 questionnaire will be applied
Faecal Incontinence Score
To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy,
* German speaking patient who is capable to fill in the questionnaire,
* signed informed consent
Exclusion Criteria
* preoperative stoma,
* not German speaking
* inability to fill in the questionnaire,
* no standardized chemo- and radiotherapy
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Susanne Drews, MD
Role: PRINCIPAL_INVESTIGATOR
Claraspital Basel
Locations
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St Claraspital
Basel, , Switzerland
Countries
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Other Identifiers
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QoL Rectal Cancer
Identifier Type: -
Identifier Source: org_study_id
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