Colon CancerNCT01326065
Implementation of Laparoscopy-assisted Surgery for Colon Cancer
An observational study of Colon Cancer, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The purpose of this study is to study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2011to Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients submitted for curative resection of colon cancer to the Dept. of Surgery, Stavanger University Hospital. Catchment area of the hospital consists of a population of 300.000 inhabitants, with Stavanger UH as the only institution with surgical service
Who may be able to join
- Age >17 years
- diagnosis of colon cancer either endoscopically, radiologically or histologically proven
- No evidence of disseminated disease on CT scan
- T1-3 according to preoperative CT scan
- written informed consent to participate
Who cannot join
- preoperative diagnosis of locally advanced tumor (T4)
- suspicion of pathological lymph nodes outside anticipated resection area
- contraindications against laparoscopic surgery, e.g. known bowel adhesions, anesthesiological concerns
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Laparoscopy-assisted Surgery for Colon Cancer. A Prospective Population-based Study
The purpose of this study is to study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice.
Read the detailed description
Prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes
- Conditions
- Colon Cancer
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term outcome
overall survival and cancer specific survival, time to relapse
Measured: 5 years
Secondary outcomes (3)
Complications related to the surgical procedure
Anastomotic leaks; intra-abdominal infections; extra-abdominal complications, i.e. non-surgical site infections, cardiovascular events, death within 30 days after surgery
Measured: 30 days
Quality of life
Quality of life as assessed by SF-36 questionary
Measured: 1 year
Quality of the surgical specimen
R0 resection or not; number of lymph nodes harvested
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2012
- Study completionFeb 2017
Why it stopped: Study had to be terminated due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hartwig Kørner, MD PhD, Principal investigator, Helse Stavanger HFJens Christian Knapp, MD, Study chair, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326065
- Sponsor's protocol ID
- SUH424503
- Status last verified
- May 2017
- First submitted
- 27 Feb 2011
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Laparoscopy-assisted Surgery for Colon Cancer. A Prospective Population-based Study
- ClinicalTrials.gov ID
- NCT01326065
- Acronym / sponsor ID
- SUH424503
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study had to be terminated due to lack of funding
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Feb 2011 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 30 Mar 2011 (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 study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice.
Detailed description
Prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients submitted for curative resection of colon cancer to the Dept. of Surgery, Stavanger University Hospital. Catchment area of the hospital consists of a population of 300.000 inhabitants, with Stavanger UH as the only institution with surgical service
Key inclusion criteria (5 listed)
- Age >17 years
- diagnosis of colon cancer either endoscopically, radiologically or histologically proven
- No evidence of disseminated disease on CT scan
- T1-3 according to preoperative CT scan
- written informed consent to participate
Key exclusion criteria (4 listed)
- preoperative diagnosis of locally advanced tumor (T4)
- suspicion of pathological lymph nodes outside anticipated resection area
- contraindications against laparoscopic surgery, e.g. known bowel adhesions, anesthesiological concerns
- lack of informed consent
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
Long term outcome
Time frame: 5 years
overall survival and cancer specific survival, time to relapse
3 secondary outcomes
Complications related to the surgical procedure
Time frame: 30 days
Quality of life
Time frame: 1 year
Quality of the surgical specimen
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Study had to be terminated due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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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.
Hartwig Kørner, MD PhD principal investigator
Helse Stavanger HF
Jens Christian Knapp, MD study chair
Helse Stavanger HF
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 Colon Cancer, run by Helse Stavanger HF at 1 site in Norway.
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 5 inclusion and 4 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 9 May 2017. 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 Norway. 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: Study had to be terminated due to lack of funding). 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?
Long term outcome (time frame: 5 years). 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 9 May 2017.