Elective ColectomieNCT00556790
Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial
A study testing Fast Track care in people with Elective Colectomie and Median Laparotomie, run by University of Lausanne Hospitals at 3 sites in Switzerland.
Trial summary
To investigate the real value of a fast track protocol compared to a standard care protocol regarding postoperative complications and hospital stay in a multicentric setting in an intention to treat fashion. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Elective Colectomie, Median Laparotomie
- What is being tested?
- Fast Track care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Nov 2004to Jan 2007
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients admitted for open colonic surgery
Who cannot join
- no primary anastomosis and/or stoma rectum resection emergency situation patients not speaking german immobile patients
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Kantonsspital Olten
Olten, 4600
Spital Uster
Uster, 8610
Kantonsspital Winterthur
Winterthur, 8401
About this study
To investigate the real value of a fast track protocol compared to a standard care protocol regarding postoperative complications and hospital stay in a multicentric setting in an intention to treat fashion.
Read the detailed description
Our fast track protocol contains the four major components perioperative fluid restriction, epidural analgesia, early oral feeding and enforced mobilisation
- Conditions
- Elective Colectomie, Median Laparotomie
- Being tested
- Standard Care, Fast Track care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareProcedure or surgery
standard fluid regime, delayed feeding
Fast Track careProcedure or surgery
restrictive fluid regime, early oral feeding, enforced mobilisation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Standard Care Receives: Procedure: Standard Care |
| 2 | Other | Fast Track Care Receives: Procedure: Fast Track care |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications until 30 days after surgery according to the zurich classification
Measured: 30 days postoperative
Secondary outcomes (1)
hospital stay, adherence to Fast track protocol
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startNov 2004
- Study completionJan 2007
Why it stopped: interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elective ColectomieStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Kantonsspital Olten, Kantonsspital Winterthur KSW, Spital Uster
- Investigators
- Sven Muller, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556790
- Sponsor's protocol ID
- 263/2003 USZ
- Status last verified
- Nov 2007
- First submitted
- 9 Nov 2007
- Last updated
- 12 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Hubner M, Muller S, Schafer M, Clavien PA, Demartines N. Impact of the nutritional risk score in fast-track colon surgery. Dig Surg. 2010;27(5):436-9. doi: 10.1159/000313692. Epub 2010 Nov 5.
PubMed 21051894Muller S, Zalunardo MP, Hubner M, Clavien PA, Demartines N; Zurich Fast Track Study Group. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. 2009 Mar;136(3):842-7. doi: 10.1053/j.gastro.2008.10.030. Epub 2008 Nov 1.
PubMed 19135997
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00556790
- Acronym / sponsor ID
- 263/2003 USZ
- Conditions
- Elective Colectomie, Median Laparotomie
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- University of Zurich, Kantonsspital Olten, Kantonsspital Winterthur KSW, Spital Uster
- Study start
- Nov 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 12 Nov 2007 (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 investigate the real value of a fast track protocol compared to a standard care protocol regarding postoperative complications and hospital stay in a multicentric setting in an intention to treat fashion.
Detailed description
Our fast track protocol contains the four major components perioperative fluid restriction, epidural analgesia, early oral feeding and enforced mobilisation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Standard CareStandard Care |
| 2 | Other | Procedure: Fast Track careFast Track Care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients admitted for open colonic surgery
Key exclusion criteria (1 listed)
- no primary anastomosis and/or stoma rectum resection emergency situation patients not speaking german immobile patients
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 |
|---|---|---|
| Standard Carestandard fluid regime, delayed feeding | Procedure or surgery | 1 |
| Fast Track carerestrictive fluid regime, early oral feeding, enforced mobilisation | Procedure or surgery | 2 |
Primary outcome
complications until 30 days after surgery according to the zurich classification
Time frame: 30 days postoperative
1 secondary outcome
hospital stay, adherence to Fast track protocol
Time frame: 30 days
Results and safety
The study was stopped early (reason given: interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2007.
- Derived from this study: PubMed 21051894Hubner M, Muller S, Schafer M, Clavien PA, Demartines N. Impact of the nutritional risk score in fast-track colon surgery. Dig Surg. 2010;27(5):436-9. doi: 10.1159/000313692. Epub 2010 Nov 5.
- Derived from this study: PubMed 19135997Muller S, Zalunardo MP, Hubner M, Clavien PA, Demartines N; Zurich Fast Track Study Group. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. 2009 Mar;136(3):842-7. doi: 10.1053/j.gastro.2008.10.030. Epub 2008 Nov 1.
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.
Sven Muller, MD principal investigator
University of Zurich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast Track care in people with Elective Colectomie and Median Laparotomie, run by University of Lausanne Hospitals at 3 sites 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 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: stopped early, as of the sponsor's last update on 12 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: interim analysis). Results are not available in the source record.
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?
complications until 30 days after surgery according to the zurich classification (time frame: 30 days postoperative). 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 NCT00556790, which also lists 2 linked publications.
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 12 Nov 2007; AzTrials last refreshed its copy on 4 Nov 2026.