Colonic CancerNCT00938210
Rehabilitation Following Laparoscopic Colonic Surgery
A study testing Laparoscopic colonic surgery in people with Colonic Cancer and Postoperative Care, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
The standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass and have a reduction in physical function, but the investigators do not know if this is also the case following laparoscopic surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonic Cancer, Postoperative Care, Fatigue
- What is being tested?
- Laparoscopic colonic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2009to Aug 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- elective colonic cancer surgery
- hemicolectomy or sigmoid resection
- informed consent
Who cannot join
- disseminated cancer
- contraindications for laparoscopic surgery
- dementia or serious psychiatric disease
- diseases or other aspects that prohibit participation
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Surgery, Herning Hospital
Herning, 7400
Department of Surgery
Randers, 8910
About this study
Official title: Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery
The standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass and have a reduction in physical function, but the investigators do not know if this is also the case following laparoscopic surgery.
This study examines how fatigue, quality of life, physical function, and body composition changes following laparoscopic colonic surgery.
Patients are examined preoperatively and postoperative day 10 and 30.
- Conditions
- Colonic Cancer, Postoperative Care, Fatigue
- Being tested
- Laparoscopic colonic surgery
- Keywords
- Colonic surgery, Postoperative care, Fatigue, Physical function, Quality of life
- Medical subject headings
- Colonic Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic colonic surgeryProcedure or surgery
Laparoscopic removal of colonic cancer
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | No intervention | Patients undergoing laparoscopic colonic surgery are compared with a historical cohort of patients undergoing similar open colonic surgery (right hemicolectomy and sigmoid resections). Receives: Procedure: Laparoscopic colonic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Measured: Preoperative to postoperative day 10
Secondary outcomes (8)
Muscular strength
Measured: From preoperatively to postoperative day 10 and 30
Change in work capacity (pulse rate)
Measured: From pre- to postoperative day 10 and 30
Balance (sway)
Measured: From preoperatively to postoperative day 10 and 30
Pain at rest and when moving
Measured: From preoperatively to postoperative day 10 and 30
Quality of life (Short Form 36 - SF-36)
Measured: From preoperatively to postoperative day 10 and 30
Body weight
Measured: From preoperatively to postoperative day 30
Body composition (fat mass and fat free mass estimated by bio-impedance)
Measured: From preoperatively to postoperative day 10 and 30
Social support
Measured: From preoperatively to postoperative day 10 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Bach Jensen, Aarhus University Hospital
- Investigators
- Martin B Jensen, MD, Ph.d., Principal investigator, Research Unit for General Practice in the North Denmark Region, Institute of Public Health, Aarhus UniversitySøren Laurberg, Professor, Study chair, Department of Surgery P, Aarhus University Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938210
- Sponsor's protocol ID
- MBJ-1
- Status last verified
- Aug 2012
- First submitted
- 10 Jul 2009
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery
- ClinicalTrials.gov ID
- NCT00938210
- Acronym / sponsor ID
- MBJ-1
- Conditions
- Colonic Cancer, Postoperative Care, Fatigue
- Keywords
- Colonic surgery, Postoperative care, Fatigue, Physical function, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Jul 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 standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass and have a reduction in physical function, but the investigators do not know if this is also the case following laparoscopic surgery.
This study examines how fatigue, quality of life, physical function, and body composition changes following laparoscopic colonic surgery.
Patients are examined preoperatively and postoperative day 10 and 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | No intervention | Procedure: Laparoscopic colonic surgeryPatients undergoing laparoscopic colonic surgery are compared with a historical cohort of patients undergoing similar open colonic surgery (right hemicolectomy and sigmoid resections). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- elective colonic cancer surgery
- hemicolectomy or sigmoid resection
- informed consent
Key exclusion criteria (4 listed)
- disseminated cancer
- contraindications for laparoscopic surgery
- dementia or serious psychiatric disease
- diseases or other aspects that prohibit participation
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 |
|---|---|---|
| Laparoscopic colonic surgeryLaparoscopic removal of colonic cancer | Procedure or surgery | Laparoscopic surgery |
Primary outcome
Fatigue
Time frame: Preoperative to postoperative day 10
8 secondary outcomes
Muscular strength
Time frame: From preoperatively to postoperative day 10 and 30
Change in work capacity (pulse rate)
Time frame: From pre- to postoperative day 10 and 30
Balance (sway)
Time frame: From preoperatively to postoperative day 10 and 30
Pain at rest and when moving
Time frame: From preoperatively to postoperative day 10 and 30
Quality of life (Short Form 36 - SF-36)
Time frame: From preoperatively to postoperative day 10 and 30
Body weight
Time frame: From preoperatively to postoperative day 30
Body composition (fat mass and fat free mass estimated by bio-impedance)
Time frame: From preoperatively to postoperative day 10 and 30
Social support
Time frame: From preoperatively to postoperative day 10 and 30
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 8 Aug 2012.
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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.
Martin B Jensen, MD, Ph.d. principal investigator
Research Unit for General Practice in the North Denmark Region, Institute of Public Health, Aarhus University
Søren Laurberg, Professor study chair
Department of Surgery P, Aarhus University Hosptial
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic colonic surgery in people with Colonic Cancer and Postoperative Care, run by Aarhus University Hospital at 2 sites 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 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: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Fatigue (time frame: Preoperative to postoperative day 10). 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 8 Aug 2012.