Major Surgical ProceduresNCT00855387
Severe Complications Triplicate the Costs of Major Surgical Procedures
An observational study of Major Surgical Procedures, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality. Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Major Surgical Procedures
- What is being tested?
- No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel
- How many people
- 1,235 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2009to Nov 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 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A cohort study with 1235 patients including consecutive patients undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) in a single tertiary care center
Who may be able to join
- Undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections)
Who cannot join
- Missing data of in-hospital costs
- Mortality
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich, Department of Visceral and Transplantation Surgery
Zurich, Canton of Zurich, 8091
About this study
Official title: Surgical Complications Dramatically Influence Overall Cost of Major Surgical Procedures
The purpose of this study is to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality.
Read the detailed description
To prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality
- Conditions
- Major Surgical Procedures
- Being tested
- No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel
- Keywords
- Clinical outcome (complications), in-hospital costs, The influence and impact of postoperative complications on in-hospital costs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowelOther
No additional intervention than the intended major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) comparing with costs
| Study group | Role | What they receive |
|---|---|---|
| Costs | Patients collected consecutively for undergoing major surgical procedures(liver, bile duct, pancreas, small bowel, colo-rectal, gastric bypass resections). Receives: Other: No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome (complications) In-hospital Costs
Measured: inhospital; peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionNov 2009
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 Major Surgical ProceduresStudies 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
- Enrolment
- 1,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- René Vonlanthen, Dr. med., Principal investigator, Department of Visceral and Transplantation Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855387
- Sponsor's protocol ID
- StV 5-2009
- Status last verified
- Nov 2009
- First submitted
- 3 Mar 2009
- Last updated
- 26 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Vonlanthen R, Slankamenac K, Breitenstein S, Puhan MA, Muller MK, Hahnloser D, Hauri D, Graf R, Clavien PA. The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients. Ann Surg. 2011 Dec;254(6):907-13. doi: 10.1097/SLA.0b013e31821d4a43.
PubMed 21562405
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Complications Dramatically Influence Overall Cost of Major Surgical Procedures
- ClinicalTrials.gov ID
- NCT00855387
- Acronym / sponsor ID
- StV 5-2009
- Conditions
- Major Surgical Procedures
- Keywords
- Clinical outcome (complications), in-hospital costs, The influence and impact of postoperative complications on in-hospital costs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,235 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Mar 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.
The purpose of this study is to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality.
Detailed description
To prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Costs | – | Other: No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowelPatients collected consecutively for undergoing major surgical procedures(liver, bile duct, pancreas, small bowel, colo-rectal, gastric bypass resections). |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort study with 1235 patients including consecutive patients undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) in a single tertiary care center
Key inclusion criteria (1 listed)
- Undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections)
Key exclusion criteria (2 listed)
- Missing data of in-hospital costs
- Mortality
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 |
|---|---|---|
| No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowelNo additional intervention than the intended major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) comparing with costs | Other | Costs |
Primary outcome
Clinical outcome (complications) In-hospital Costs
Time frame: inhospital; peri-operative
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 26 Nov 2009.
- Derived from this study: PubMed 21562405Vonlanthen R, Slankamenac K, Breitenstein S, Puhan MA, Muller MK, Hahnloser D, Hauri D, Graf R, Clavien PA. The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients. Ann Surg. 2011 Dec;254(6):907-13. doi: 10.1097/SLA.0b013e31821d4a43.
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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.
René Vonlanthen, Dr. med. principal investigator
Department of Visceral and Transplantation Surgery
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 Major Surgical Procedures, 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 1 inclusion and 2 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 26 Nov 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?
Clinical outcome (complications) In-hospital Costs (time frame: inhospital; peri-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855387, 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 26 Nov 2009.