Colorectal Liver MetastasesNCT00184834
Quality of Life and Liver Metastases
An observational study of Colorectal Liver Metastases and Quality of Life, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
An increasing aggressiveness in the surgical approach of colorectal liver metastases is observed. This seems only justified when, besides prolongation of survival, also the health status of patients is considered. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Colorectal Liver Metastases, Quality of Life
- What is being tested?
- quality of life
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 1999to Nov 2002
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- colorectal liver metastases (operable and non operable disease) and participation by means of filling in quality of life instruments
Who cannot join
- drop out and therefore loss of quality of life instruments
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: Quality of Life After Surgical Treatment of Colorectal Liver Metastases
An increasing aggressiveness in the surgical approach of colorectal liver metastases is observed. This seems only justified when, besides prolongation of survival, also the health status of patients is considered. The aim of this prospective study is to investigate the impact of surgery on health-related quality of life in this specific patient population operated for colorectal liver metastases.Furthermore, as the indications for hepatic resection are broadened and patients with more extensive liver disease are operated on, the chance of non operable disease at laparotomy will increase. The effects of such an event on HRQol are also studied.
Read the detailed description
In a prospective study several patients groups were identified. Patients undergoing liver resection and/or local ablative therapy. Patients with non operable disease at (explorative) laparotomy and outpatients with non operable disease as shown during work up for liver resection. Several validated instruments on HRQoL were ompleted preoperatively (baseline), a half month after operation and then every three months.
- Conditions
- Colorectal Liver Metastases, Quality of Life
- Being tested
- quality of life
- Keywords
- colorectal, liver, metastases, health-related quality of life, surgery
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of lifeBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 1999
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Theo Ruers, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184834
- Sponsor's protocol ID
- qol1
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Publications
Langenhoff BS, Krabbe PF, Wobbes T, Ruers TJ. Quality of life as an outcome measure in surgical oncology. Br J Surg. 2001 May;88(5):643-52. doi: 10.1046/j.1365-2168.2001.01755.x.
PubMed 11350434
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Surgical Treatment of Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT00184834
- Acronym / sponsor ID
- qol1
- Conditions
- Colorectal Liver Metastases, Quality of Life
- Keywords
- colorectal, liver, metastases, health-related quality of life, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 1999
- Study completion
- Nov 2002
- First posted
- 16 Sep 2005 (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.
An increasing aggressiveness in the surgical approach of colorectal liver metastases is observed. This seems only justified when, besides prolongation of survival, also the health status of patients is considered. The aim of this prospective study is to investigate the impact of surgery on health-related quality of life in this specific patient population operated for colorectal liver metastases.Furthermore, as the indications for hepatic resection are broadened and patients with more extensive liver disease are operated on, the chance of non operable disease at laparotomy will increase. The effects of such an event on HRQol are also studied.
Detailed description
In a prospective study several patients groups were identified. Patients undergoing liver resection and/or local ablative therapy. Patients with non operable disease at (explorative) laparotomy and outpatients with non operable disease as shown during work up for liver resection. Several validated instruments on HRQoL were ompleted preoperatively (baseline), a half month after operation and then every three months.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- colorectal liver metastases (operable and non operable disease) and participation by means of filling in quality of life instruments
Key exclusion criteria (1 listed)
- drop out and therefore loss of quality of life instruments
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 |
|---|---|---|
| quality of life | Behavioural | – |
Primary outcome
Not reported in the source record.
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 16 Sep 2005.
- Background: PubMed 11350434Langenhoff BS, Krabbe PF, Wobbes T, Ruers TJ. Quality of life as an outcome measure in surgical oncology. Br J Surg. 2001 May;88(5):643-52. doi: 10.1046/j.1365-2168.2001.01755.x.
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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.
Theo Ruers, MD, PhD principal investigator
Radboud University Medical Center
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 Colorectal Liver Metastases and Quality of Life, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 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 16 Sep 2005. 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 Netherlands. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184834, which also lists 1 linked publication.
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 16 Sep 2005.