Nurse-or Surgeon-led Follow-up After Rectal Cancer

This study has been completed.

Sponsor:

Information provided by:

Centrallasarettet Västerås

ClinicalTrials.gov Identifier:

NCT01045200

First received: January 6, 2010

Last updated: January 7, 2010

Last verified: January 2002

History of Changes

Tracking Information
First Received Date ^ICMJE	January 6, 2010
Last Updated Date	January 7, 2010
Start Date ^ICMJE	January 2002
Primary Completion Date	October 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 7, 2010)	Patient satisfaction [ Time Frame: At each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01045200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 7, 2010)	Resource utilisation [ Time Frame: at each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Nurse-or Surgeon-led Follow-up After Rectal Cancer
Official Title ^ICMJE	Nurse-or Surgeon-led Follow-up After Rectal Cancer: a Randomised Trial.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Operated for rectal cancer at the colorectal unit of the Central Hospital in Västerås, Sweden.
Condition ^ICMJE	Rectal Cancer
Intervention ^ICMJE	Other: Comparison of follow-up Comparison of follow-up by nurse or surgeon after rectal cancer surgery Other Name: Rectal cancer patients
Study Group/Cohort (s)	Follow-up Patients curatively operated for rectal cancer Intervention: Other: Comparison of follow-up
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	110
Completion Date	September 2009
Primary Completion Date	October 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients curatively operated for rectal cancer. Patients had to be more than 18 years of age and written and oral informed consent was obtained. Exclusion Criteria: Those with psychiatric disorders, dementia and whose general condition had deteriorated with an expected survival of less than six months were not eligible.
Gender	Both
Ages	19 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01045200
Other Study ID Numbers ^ICMJE	DNR 01-498
Has Data Monitoring Committee	Yes
Responsible Party	Kenneth Smedh MD, PhD, Head of Colorectal Surgery, Department of Surgery, Central Hospital, Västerås, Sweden
Study Sponsor ^ICMJE	Centrallasarettet Västerås
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centrallasarettet Västerås
Verification Date	January 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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