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Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial

Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00895388
Enrollment
0
Registered
2009-05-08
Start date
2009-05-31
Completion date
2019-12-02
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Incontinence, Quality of Life, Sexual Function, Urinary Incontinence

Keywords

Urinary function, Anal function

Brief summary

Quality of life after rectal surgery is reported to be impaired. Side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. The investigators hypotheses is that structured rehabilitation program addressing these problems will improve quality of life. A RCT are performed in order to document the effects of the rehabilitation.

Interventions

Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation

Sponsors

Helse Nord
CollaboratorINDUSTRY
University Hospital of North Norway
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients

Exclusion criteria

* Older than 75 years Mentally or physically not able to participate Non curative surgical treatment

Design outcomes

Primary

MeasureTime frame
Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38)Baseline, 3, 6, 12,18 and 24 months postoperative.
Quality of LIfe (EQ 5D)Baseline, 3,6,12, 18 and 24.

Secondary

MeasureTime frame
St Marks incontinenceBaseline, 3, 12 and 24
ICIQ sexual functionbaseline, 3,12 and 24
ICIQ Urinary function Short formbaseline,3, 12 and 24 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026