No registrations found.
ID
Source
Brief title
Health condition
Rectal carcinoma
Stoma problems
Functional outcomes
Quality of life
Rectum carcinoom
Stoma problemen
Functionele uitkomsten
Kwaliteit van leven
Sponsors and support
Intervention
Outcome measures
Primary outcome
What does a patient choose: resection with a primary anastomosis or with a permanent colostomy
Secondary outcome
Quality of life and functional outcomes, measured with multiple validated questionnaires
Background summary
Elderly patients who have been operated on for rectal carcinoma and received either a primary anastomosis or a permanent colostomy will be invited to participate in an evaluation study. Validated questionnaires will be sent, patients can self-administer these at home.
Mean results of these questionnaires will be grouped according to stoma status and will be shared with the patients.
There will be two time points of questionnaires.
The primary outcome will be measured during the second time point.
Study objective
The hypothesis is that a permanent colostomy in elderly patients with rectal carcinoma has no less quality of life compared to elderly patients with a primary anastomosis.
Study design
The questionnaires will be sent to eligible patients at home. There will be 2 timepoints of questionnaires.
Intervention
None. This is an evaluation study using validated questionnaires that will be self-administered by patients at home.
Reza Indrakusuma
Alkmaar 1800 AM
The Netherlands
(072) 548 2418
r.indrakusuma@mca.nl
Reza Indrakusuma
Alkmaar 1800 AM
The Netherlands
(072) 548 2418
r.indrakusuma@mca.nl
Inclusion criteria
- histological proven rectal carcinoma
- 70 years of age at the time of operation
- elective low anterior resection between 31-12-2007 and 01-01-2014
Exclusion criteria
- acute resection
- transanal endoscopic microsurgery
- abdominoperineal resection
- diagnosed with cognitive impairment
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4427 |
| NTR-old | NTR4551 |
| Other | METC Noord-Holland : M014-003 |