Colon TumorNCT01831245
Right-sided Colon Tumor, Laparoscopic Versus Open Surgery, in an ERAS Protocol
An observational study of Colon Tumor, run by Karolinska Institutet at 3 sites in Sweden.
Trial summary
Register study. Patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an ERAS (Enhanced Recovery After Surgery) protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Tumor
- How many people
- 125 participants
- Where
- 3 sitesSweden
- Study dates
- Jan 2011to Jul 2014
- How long will I take part?
- 2 Years
- 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: Right sided colom tumor or large benign adenoids
Who may be able to join
- right-sided colon tumor or large benign adenoids
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Örebro University Hospital
Örebro, 701 85
Ersta Hospital
Stockholm, 116 91
Danderyds Hospital
Stockholm, 182 88
About this study
Official title: Right-sided Colon Tumor, Laparoscopic and Open Surgery, in an ERAS Protocol
Register study. Patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an ERAS (Enhanced Recovery After Surgery) protocol.
Hypothesis:
Operation of right-sided colon tumor and large benign adenoids, a better selection of patients for open or laparoscopic surgery can improve short term results.
- Conditions
- Colon Tumor
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Anatomic diagnosis (PAD) on a tumor biopsy
After PAD result, malign or benign tumor, type of malign tumor,tumor growth, stage, lymphatic recharge.
Right selection of patients to laparoscopic versus open surgery in relation to PAD result?
Measured: day of surgery
Secondary outcomes (2)
Length of hospital stay, days
Compare laparoscopic versus open surgery
Measured: 30 days after surgery
C - reactive protein
Inflammation answer laparoscopic versus open surgery
Measured: 1-7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJan 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon TumorStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Prospective
- Enrolment
- 125 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital, Region Örebro County, Ersta Hospital, Sweden
- Responsible party
- Principal investigator, Ulf Gustafsson, Karolinska Institutet
- Investigators
- Ulf Gustafsson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831245
- Sponsor's protocol ID
- 2012/2105-31/2
- Status last verified
- Feb 2015
- First submitted
- 25 Feb 2013
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right-sided Colon Tumor, Laparoscopic and Open Surgery, in an ERAS Protocol
- ClinicalTrials.gov ID
- NCT01831245
- Acronym / sponsor ID
- 2012/2105-31/2
- Conditions
- Colon Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Danderyd Hospital, Region Örebro County, Ersta Hospital, Sweden
- Study start
- Jan 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Apr 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.
Register study. Patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an ERAS (Enhanced Recovery After Surgery) protocol.
Hypothesis:
Operation of right-sided colon tumor and large benign adenoids, a better selection of patients for open or laparoscopic surgery can improve short term results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Right sided colom tumor or large benign adenoids
Key inclusion criteria (1 listed)
- right-sided colon tumor or large benign adenoids
Key exclusion criteria (1 listed)
- none
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
Pathological Anatomic diagnosis (PAD) on a tumor biopsy
Time frame: day of surgery
After PAD result, malign or benign tumor, type of malign tumor,tumor growth, stage, lymphatic recharge. Right selection of patients to laparoscopic versus open surgery in relation to PAD result?
2 secondary outcomes
Length of hospital stay, days
Time frame: 30 days after surgery
C - reactive protein
Time frame: 1-7 days after surgery
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 20 Feb 2015.
Related trials for Colon Tumor
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Ulf Gustafsson, MD, PhD principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Tumor, run by Karolinska Institutet at 3 sites in Sweden.
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: finished, as of the sponsor's last update on 20 Feb 2015. 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 Sweden. 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?
Pathological Anatomic diagnosis (PAD) on a tumor biopsy (time frame: day of surgery). 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 20 Feb 2015.