NCT00895388

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.

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 May 2009

Longer than P75 for not_applicable quality-of-life

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withdrawn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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
Last Updated

March 5, 2024

Status Verified

November 1, 2011

Enrollment Period

10.5 years

First QC Date

May 7, 2009

Last Update Submit

March 4, 2024

Conditions

Quality of LifeSexual FunctionUrinary IncontinenceAnal Incontinence

Keywords

Urinary functionAnal function

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • St Marks incontinence

    Baseline, 3, 12 and 24

  • ICIQ sexual function

    baseline, 3,12 and 24

  • ICIQ Urinary function Short form

    baseline,3, 12 and 24 months

Study Arms (2)

Structured Rehabilitation program

OTHER
Behavioral: Structured Rehabilitation program

Controls

NO INTERVENTION

Interventions

Structured Rehabilitation programBEHAVIORAL

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

Structured Rehabilitation program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of gastrointestinal surgery, University Hospital of North Norway

Tromsø, N-9037, Norway

Location

MeSH Terms

Conditions

Urinary IncontinenceEncopresis

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Rolv-Ole Lindsetmo, MD, Phd, Mph

    Dep of gastrointestinal surgery, University Hospital of North Norway

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2019

Study Completion

December 2, 2019

Last Updated

March 5, 2024

Record last verified: 2011-11

Locations

NO(1)