Rectal CancerNCT01045200
Nurse-or Surgeon-led Follow-up After Rectal Cancer
An observational study of Rectal Cancer, run by Centrallasarettet Västerås at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Comparison of follow-up
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2002to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Operated for rectal cancer at the colorectal unit of the Central Hospital in Västerås, Sweden.
Who may be able to join
- Patients curatively operated for rectal cancer.
- Patients had to be more than 18 years of age and written and oral informed consent was obtained.
Who cannot join
- Those with psychiatric disorders, dementia and whose general condition had deteriorated with an expected survival of less than six months were not eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-or Surgeon-led Follow-up After Rectal Cancer: a Randomised Trial.
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.
- Conditions
- Rectal Cancer
- Being tested
- Comparison of follow-up
- Keywords
- rectal cancer, follow-up, specialist nurse
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of follow-upOther
Also called Rectal cancer patients
Comparison of follow-up by nurse or surgeon after rectal cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| Follow-up | Patients curatively operated for rectal cancer Receives: Other: Comparison of follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Measured: 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
Measured: at each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2002
- Primary completionOct 2004
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrallasarettet Västerås
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045200
- Sponsor's protocol ID
- DNR 01-498
- Status last verified
- Jan 2002
- First submitted
- 6 Jan 2010
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-or Surgeon-led Follow-up After Rectal Cancer: a Randomised Trial.
- ClinicalTrials.gov ID
- NCT01045200
- Acronym / sponsor ID
- DNR 01-498
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, follow-up, specialist nurse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centrallasarettet VästeråsUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Oct 2004 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up | – | Other: Comparison of follow-upPatients curatively operated for rectal cancer |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Operated for rectal cancer at the colorectal unit of the Central Hospital in Västerås, Sweden.
Key inclusion criteria (2 listed)
- Patients curatively operated for rectal cancer.
- Patients had to be more than 18 years of age and written and oral informed consent was obtained.
Key exclusion criteria (1 listed)
- Those with psychiatric disorders, dementia and whose general condition had deteriorated with an expected survival of less than six months were not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of follow-upAlso: Rectal cancer patientsComparison of follow-up by nurse or surgeon after rectal cancer surgery | Other | Follow-up |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Centrallasarettet Västerås at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2010.