NCT01045200

Brief Summary

Follow-up programmes consume a large amount of resources with less time for the surgeon to take on new patients. The aim of this randomised study was to compare patient satisfaction, resource utilisation, and medical safety in patients curatively operated for rectal cancer that were followed-up by a surgeon or a nurse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
Last Updated

January 8, 2010

Status Verified

January 1, 2002

Enrollment Period

2.8 years

First QC Date

January 6, 2010

Last Update Submit

January 7, 2010

Conditions

Rectal Cancer

Keywords

rectal cancerfollow-upspecialist nurse

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    At each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery.

Secondary Outcomes (1)

  • Resource utilisation

    at each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery.

Study Arms (1)

Follow-up

Patients curatively operated for rectal cancer

Other: Comparison of follow-up

Interventions

Comparison of follow-upOTHER

Comparison of follow-up by nurse or surgeon after rectal cancer surgery

Also known as: Rectal cancer patients
Follow-up

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Operated for rectal cancer at the colorectal unit of the Central Hospital in Västerås, Sweden.

You may qualify if:

  • Patients curatively operated for rectal cancer.
  • Patients had to be more than 18 years of age and written and oral informed consent was obtained.

You may not qualify if:

  • Those with psychiatric disorders, dementia and whose general condition had deteriorated with an expected survival of less than six months were not eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Surgery, Central Hospital

Västerås, Sweden

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 8, 2010

Study Start

January 1, 2002

Primary Completion

October 1, 2004

Study Completion

September 1, 2009

Last Updated

January 8, 2010

Record last verified: 2002-01

Locations

SE(1)