Cogntive Changes After SurgeryNCT01775202
Cognitive Changes After Fast-track Colon Surgery
An observational study of Cogntive Changes After Surgery, run by Lene Krenk at 1 site in Denmark.
Trial summary
This descriptive study aims to evalaute in a retrospective way the incidence of cogntive changes postoperatively after fast-track colon surgery at Hvidovre Hospital. This survey is based on chart reviews. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cogntive Changes After Surgery
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jun 2014
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elderly patients > 60 years, undergoing fast-track colon surgery at Hvidovre Hospital during 2010-2012.
Who may be able to join
- > 59 years
- undergoing colon surgery at Hvidovre Hospital
- surgery and perioperative care in a fast-track setting
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept. of abdominal surgery (colon section) Hvidovre Hospital
Hvidovre
Jens Andersen, MD, jens.andersen@regionh.dk
About this study
This descriptive study aims to evalaute in a retrospective way the incidence of cogntive changes postoperatively after fast-track colon surgery at Hvidovre Hospital. This survey is based on chart reviews.
- Conditions
- Cogntive Changes After Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive change postoperatively based on chart review
Measured: during hospital stay (postoperative day 0-3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cogntive Changes After SurgeryStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lene Krenk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lene Krenk, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775202
- Sponsor's protocol ID
- H-3-2012-FSP69
- Status last verified
- Jan 2013
- First submitted
- 22 Jan 2013
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Changes After Fast-track Colon Surgery
- ClinicalTrials.gov ID
- NCT01775202
- Acronym / sponsor ID
- H-3-2012-FSP69
- Conditions
- Cogntive Changes After Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lene KrenkUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 24 Jan 2013 (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.
This descriptive study aims to evalaute in a retrospective way the incidence of cogntive changes postoperatively after fast-track colon surgery at Hvidovre Hospital. This survey is based on chart reviews.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elderly patients > 60 years, undergoing fast-track colon surgery at Hvidovre Hospital during 2010-2012.
Key inclusion criteria (3 listed)
- > 59 years
- undergoing colon surgery at Hvidovre Hospital
- surgery and perioperative care in a fast-track setting
Key exclusion criteria (0 listed)
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
cognitive change postoperatively based on chart review
Time frame: during hospital stay (postoperative day 0-3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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.
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 Cogntive Changes After Surgery, run by Lene Krenk at 1 site in Denmark.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Jan 2013. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henrik Kehlet, Prof. MD (004535454074, henrik.kehlet@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive change postoperatively based on chart review (time frame: during hospital stay (postoperative day 0-3)). 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 24 Jan 2013.