ConstipationERCoPHNCT04068415
Development of a Constipation Risk Assessment Scale for Hospitalized Patients.
An observational study of Constipation, run by University Hospital, Bordeaux.
Trial summary
Develop a risk assessment scale for constipation of hospitalized patients to identify at an early stage high-risk individuals and to implement the appropriate means of prevention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Constipation risk assessment scale
- How many people
- 516 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2012to 16 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in services where constipation is a major concern : orthopedic surgery (Bordeaux), plastic surgery (Bordeaux), medical cardiology (Bordeaux) and internal medicine (Limoges).
Who may be able to join
- Male or female 18 years or older
- Swallowing, drinking and eating
- Hospitalized in one of the participating services
- Hospitalized for a period of at least 4 days
- Able to give informed consent and answer questions about his or her lifestyle
Who cannot join
- Patient with major constipation at baseline (no stool for at least 6 days)
- History of intestinal surgery during the 10 days preceding the study,
- Hospitalized in palliative care or bed identified palliative care.
About this study
Develop a risk assessment scale for constipation of hospitalized patients to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.
Read the detailed description
Constipation remains a prominent problem in the hospital care setting given the accumulation of contributing factors. Indeed, one of the most common causes of constipation is the existence of irregular habits in stool schedules, including the fact of delaying the time to go to the toilet, which causes the subject for a prolonged period of time to inhibit symptoms. defecation reflexes.
These disorders are often increased by the lack of exercise and prolonged bed rest, which cause a lack of muscle of the abdominal strap, the abdominals not being able to play their role of compression.
Some drugs are also a major cause of the difficulty of intestinal elimination, including opiates, anticholinergics, anti-depressants, etc.
Finally, an unbalanced diet, a water deficiency are aggravating factors, as is anxiety. In the medical and para-medical literature, there is no complete and validated tool for assessing the risk of constipation at the admission of a hospital stay. This project is to develop a constipation risk assessment scale, which can be used autonomously by nurses, based on the risk factors identified in the literature, scales published in English, and 2007 recommendations from the French National Society of Gastroenterology, recommendations of the High Authority of Health and a consensus of experts. The use of such a tool would make it possible to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.
- Conditions
- Constipation
- Being tested
- Constipation risk assessment scale
- Keywords
- Hospitalized patients
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constipation risk assessment scaleOther
questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation yes/no
Less than a saddle in the first 4 days and prescription of laxatives
Measured: On the 4th day of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start6 May 2012
- Primary completion16 Apr 2014
- Study completion16 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie BERGER, Mrs, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068415
- Sponsor's protocol ID
- CHUBX 2010/44
- Acronym
- ERCoPH
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Berger V, Germain C, Lacomere R, Bader C, Gerbouin O, Benard A. [Consensus approach: Prior to the construction of an evaluation scale of risk constipation patients hospitalized for nursing practice]. Rev Epidemiol Sante Publique. 2018 Sep;66(5):301-309. doi: 10.1016/j.respe.2018.07.002. Epub 2018 Sep 1. French.
PubMed 30181005
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Constipation Risk Assessment Scale for Hospitalized Patients.
- ClinicalTrials.gov ID
- NCT04068415
- Acronym / sponsor ID
- ERCoPH / CHUBX 2010/44
- Conditions
- Constipation
- Keywords
- Hospitalized patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 May 2012 (actual)
- Primary completion
- 16 Apr 2014 (actual)
- Study completion
- 16 Apr 2014 (actual)
- First posted
- 28 Aug 2019 (actual)
- 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.
Develop a risk assessment scale for constipation of hospitalized patients to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.
Detailed description
Constipation remains a prominent problem in the hospital care setting given the accumulation of contributing factors. Indeed, one of the most common causes of constipation is the existence of irregular habits in stool schedules, including the fact of delaying the time to go to the toilet, which causes the subject for a prolonged period of time to inhibit symptoms. defecation reflexes.
These disorders are often increased by the lack of exercise and prolonged bed rest, which cause a lack of muscle of the abdominal strap, the abdominals not being able to play their role of compression.
Some drugs are also a major cause of the difficulty of intestinal elimination, including opiates, anticholinergics, anti-depressants, etc.
Finally, an unbalanced diet, a water deficiency are aggravating factors, as is anxiety. In the medical and para-medical literature, there is no complete and validated tool for assessing the risk of constipation at the admission of a hospital stay. This project is to develop a constipation risk assessment scale, which can be used autonomously by nurses, based on the risk factors identified in the literature, scales published in English, and 2007 recommendations from the French National Society of Gastroenterology, recommendations of the High Authority of Health and a consensus of experts. The use of such a tool would make it possible to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.
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
- Patients in services where constipation is a major concern : orthopedic surgery (Bordeaux), plastic surgery (Bordeaux), medical cardiology (Bordeaux) and internal medicine (Limoges).
Key inclusion criteria (5 listed)
- Male or female 18 years or older
- Swallowing, drinking and eating
- Hospitalized in one of the participating services
- Hospitalized for a period of at least 4 days
- Able to give informed consent and answer questions about his or her lifestyle
Key exclusion criteria (3 listed)
- Patient with major constipation at baseline (no stool for at least 6 days)
- History of intestinal surgery during the 10 days preceding the study,
- Hospitalized in palliative care or bed identified palliative care.
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 |
|---|---|---|
| Constipation risk assessment scalequestionnaires | Other | – |
Primary outcome
Constipation yes/no
Time frame: On the 4th day of hospitalization
Less than a saddle in the first 4 days and prescription of laxatives
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 18 Jun 2026.
- Results publication: PubMed 30181005Berger V, Germain C, Lacomere R, Bader C, Gerbouin O, Benard A. [Consensus approach: Prior to the construction of an evaluation scale of risk constipation patients hospitalized for nursing practice]. Rev Epidemiol Sante Publique. 2018 Sep;66(5):301-309. doi: 10.1016/j.respe.2018.07.002. Epub 2018 Sep 1. French.
- 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.
Valérie BERGER, Mrs principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by University Hospital, Bordeaux.
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 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 yes/no (time frame: On the 4th day of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068415, which also lists 1 linked publication.
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 18 Jun 2026.