Serious Complications Following Liver ResectionNCT01003197
Novel Preoperative Score Predicting Outcome Following Liver Resection
An observational study of Serious Complications Following Liver Resection, run by University of Zurich at 1 site in Switzerland.
Trial summary
To develop and validate a score to predict serious complications following liver resection using pre-operative risk factors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Serious Complications Following Liver Resection
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2009to Oct 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HPB center Zurich, Switzerland
Who may be able to join
- >= 18 years
- liver resection
Who cannot join
- Trauma cases
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral and Transplantation Surgery, University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
To develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
Read the detailed description
Liver surgery is associated with a substantial rate of complications. Early identification of patients at risk of serious complications is important in order to adapt therapeutic strategies and to improve quality. The purpose of this study is to develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
- Keywords
- Development, Validation, Prediction Score, Complication, Liver resection, develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| complication group < III | Not described | |
| complication group >= III | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
Measured: postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Complications Following Liver ResectionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Breitenstein, Dr. med., Principal investigator, Department of Visceral and Transplantation Surgery, University Hospital of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003197
- Sponsor's protocol ID
- StV 2009
- Status last verified
- Oct 2009
- First submitted
- 27 Oct 2009
- Last updated
- 28 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Preoperative Score Predicting Outcome Following Liver Resection
- ClinicalTrials.gov ID
- NCT01003197
- Acronym / sponsor ID
- StV 2009
- Keywords
- Development, Validation, Prediction Score, Complication, Liver resection, develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 Oct 2009 (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.
To develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
Detailed description
Liver surgery is associated with a substantial rate of complications. Early identification of patients at risk of serious complications is important in order to adapt therapeutic strategies and to improve quality. The purpose of this study is to develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complication group < III | – | – |
| complication group >= III | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HPB center Zurich, Switzerland
Key inclusion criteria (2 listed)
- >= 18 years
- liver resection
Key exclusion criteria (1 listed)
- Trauma cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
Time frame: postoperative
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 28 Oct 2009.
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.
Stefan Breitenstein, Dr. med. principal investigator
Department of Visceral and Transplantation Surgery, University Hospital of Zurich
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 Serious Complications Following Liver Resection, run by University of Zurich at 1 site in Switzerland.
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 28 Oct 2009. 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 Switzerland. 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?
develop and validate a score to predict serious complications following liver resection using pre-operative risk factors. (time frame: postoperative). 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 28 Oct 2009.