Postoperative ConstipationNCT00364169
Prevention of Constipation: Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery
A study testing Degree of constipation in people with Postoperative Constipation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the study is to reduce the incidence of postoperative constipation by systematic nurse assessment, interventions and evaluation, in the first month after thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Constipation
- What is being tested?
- Degree of constipation
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Dec 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted for planned lung surgery
- Patients are capable
- Able to talk and understand Danish
Who cannot join
- Patients with colostomy and / or ileostomy
- Neurological or abdominal diseases
- Feed through a tube
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiothoracic Surgery, The Heart Center, University hospital Rigshospitalet
Copenhagen, 2100
About this study
Official title: Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery
The purpose of the study is to reduce the incidence of postoperative constipation by systematic nurse assessment, interventions and evaluation, in the first month after thoracic surgery.
- Conditions
- Postoperative Constipation
- Being tested
- Degree of constipation
- Keywords
- constipation, cancer, surgery, intervention, nursing, postoperative
- Medical subject headings
- Constipation, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degree of constipationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation incidence the first month after surgery
Secondary outcomes (2)
Defecation pattern measured after The Bristol Stool scale.
ADL (after Sallings functional scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ConstipationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of public health, department of nursing sciences, Århus University, Denmark
- Investigators
- Lene S. Rasmussen, RN,Stud.-MPH, Principal investigator, Department of Cardiothoracic Surgery, The Heart Center, University hospital, Rigshospitalet, Copenhagen, DenmarkLene S. Rasmussen, RN,Stud.-MPH, Study director, Department of Cardiothoracic Surgery, The Heart Center, University hospital Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364169
- Sponsor's protocol ID
- KF 01 308399
- Status last verified
- Jun 2008
- First submitted
- 11 Aug 2006
- Last updated
- 1 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT00364169
- Acronym / sponsor ID
- KF 01 308399
- Conditions
- Postoperative Constipation
- Keywords
- constipation, cancer, surgery, intervention, nursing, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Institute of public health, department of nursing sciences, Århus University, Denmark
- Study start
- Sep 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Aug 2006 (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 the study is to reduce the incidence of postoperative constipation by systematic nurse assessment, interventions and evaluation, in the first month after thoracic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted for planned lung surgery
- Patients are capable
- Able to talk and understand Danish
Key exclusion criteria (3 listed)
- Patients with colostomy and / or ileostomy
- Neurological or abdominal diseases
- Feed through a tube
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 |
|---|---|---|
| Degree of constipation | Procedure or surgery | – |
Primary outcome
Constipation incidence the first month after surgery
2 secondary outcomes
Defecation pattern measured after The Bristol Stool scale.
ADL (after Sallings functional scale)
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 1 Jul 2008.
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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.
Lene S. Rasmussen, RN,Stud.-MPH principal investigator
Department of Cardiothoracic Surgery, The Heart Center, University hospital, Rigshospitalet, Copenhagen, Denmark
Lene S. Rasmussen, RN,Stud.-MPH study director
Department of Cardiothoracic Surgery, The Heart Center, University hospital Rigshospitalet, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Degree of constipation in people with Postoperative Constipation, run by Copenhagen University Hospital, Rigshospitalet 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 3 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 1 Jul 2008. 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?
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?
Constipation incidence the first month after 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 1 Jul 2008.