ConstipationNCT05683743
The Incidence, Risk Factors, and Effects of Constipation in Critical Patients
An observational study of Constipation, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the early, late, and total constipation frequency, related factors, and their effects on the hospitalization day, gastric residual volume, vomiting, distension, and diarrhea, the feeding type, white blood cells, and C-Reactive Protein levels, and body temperature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 22 Jul 2019
- How long will I take part?
- 5 Days
- 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: The data were collected from the Anesthesia and Reanimation Intensive Care Unit in a state hospital of Bolu in 2019. To determine the number of observations in our study, a pilot study was conducted with 20 patients. These patients were also included in the main study. The constipation rate in the intensive care unit was determined as 67% in the pilot study. Considering this ratio, the sample size was calculated using the PASS 11 program. Accordingly, at least 86 patients had to be included in the study keeping a 95% probability and 10% deviation. The sample consisted of 116 patients who were reachable during the study, met the inclusion criteria, and volunteered to participate in the study.
Who may be able to join
- >18 years
- Not abdominal surgery
- Not stoma
- Not constipation during admission
- Not intraperitoneal infection
- Not had a recent colonoscopy -> 5 hospitalization days
Who cannot join
- Having prolonged constipation and complications (such as decreased bowel sounds, and excessive distension)
- Order for regular laxatives or enemas
- Not meet inclusion criteria during follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Izzet Baysal State Hospital, Anesthesia Intensive Care Unit
Bolu, Merkez, 14030
About this study
Official title: The Incidence, Risk Factors, and Effects of Constipation in Critical Patients: An Observational Cross-sectional Study
This study aimed to investigate the early, late, and total constipation frequency, related factors, and their effects on the hospitalization day, gastric residual volume, vomiting, distension, and diarrhea, the feeding type, white blood cells, and C-Reactive Protein levels, and body temperature.
Read the detailed description
Constipation is one of the most encountered nursing problems in intensive care unit patients.
Constipation is an important issue, especially in intensive care patients, requiring careful discussion since it has negative effects as well as high incidence and excessive risk factors. Furthermore, untreated constipation in these patients delays enteral feeding prolonging the time of weaning from the mechanical ventilator, which consequently increases the duration of stay in the intensive care unit. Additionally, it involves complications such as distention, nausea-vomiting, an increase in bacterial infection rate, high morbidity, and mortality. Therefore, the definitions, risks, and effects of constipation, especially early and late constipation, in critically ill patients should be determined for evidence-based interventions. However, studies on the subject are limited.
- Conditions
- Constipation
- Keywords
- Critical care, Constipation, Intensive care, Nursing
- Medical subject headings
- Constipation
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of total constipation, early-type constipation and late-type constipation
During the study, patients in the intensive care unit with no bowel movements for four days were accepted as constipated. The ones without defecation for five days were evaluated in the early type constipation group, while the patients without defecation for six days or more were evaluated in the late-type constipation group.
Measured: Through study completion, an average of five months
Secondary outcomes (5)
he duration of stay in the intensive care unit
the duration of stay in the intensive care unit as days (how many days?)
Measured: Through study completion, an average of five months
the amount of gastric residual volume
the amount of gastric residual volume in ml/cc
Measured: Through study completion, an avarage of five months
developing vomiting
developing vomiting as numbers (how many times?)
Measured: Through study completion, an average of five months
Level of white blood cells
level of white blood cells (WBC) in mcL
Measured: Through study completion, an average of five months
body temperature
body temperature in celsius
Measured: Through study completion, an average of five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Dec 2018
- Primary completion5 May 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu AKMAN YILMAZ, Abant Izzet Baysal University
- Investigators
- Arzu AKMAN YILMAZ, RN, PhD., Principal investigator, Bolu Izzet Baysal UniversitySeyma OZDEMIR, RN,MSN., Principal investigator, Pursaklar State HospitalEsra OZDEMIR, MD., Principal investigator, Bolu Izzet Baysal State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683743
- Sponsor's protocol ID
- BAIBU-HEM-AAY-001
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence, Risk Factors, and Effects of Constipation in Critical Patients: An Observational Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05683743
- Acronym / sponsor ID
- BAIBU-HEM-AAY-001
- Conditions
- Constipation
- Keywords
- Critical care, Constipation, Intensive care, Nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 13 Jan 2023 (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.
This study aimed to investigate the early, late, and total constipation frequency, related factors, and their effects on the hospitalization day, gastric residual volume, vomiting, distension, and diarrhea, the feeding type, white blood cells, and C-Reactive Protein levels, and body temperature.
Detailed description
Constipation is one of the most encountered nursing problems in intensive care unit patients.
Constipation is an important issue, especially in intensive care patients, requiring careful discussion since it has negative effects as well as high incidence and excessive risk factors. Furthermore, untreated constipation in these patients delays enteral feeding prolonging the time of weaning from the mechanical ventilator, which consequently increases the duration of stay in the intensive care unit. Additionally, it involves complications such as distention, nausea-vomiting, an increase in bacterial infection rate, high morbidity, and mortality. Therefore, the definitions, risks, and effects of constipation, especially early and late constipation, in critically ill patients should be determined for evidence-based interventions. However, studies on the subject are limited.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data were collected from the Anesthesia and Reanimation Intensive Care Unit in a state hospital of Bolu in 2019. To determine the number of observations in our study, a pilot study was conducted with 20 patients. These patients were also included in the main study. The constipation rate in the intensive care unit was determined as 67% in the pilot study. Considering this ratio, the sample size was calculated using the PASS 11 program. Accordingly, at least 86 patients had to be included in the study keeping a 95% probability and 10% deviation. The sample consisted of 116 patients who were reachable during the study, met the inclusion criteria, and volunteered to participate in the study.
Key inclusion criteria (6 listed)
- >18 years
- Not abdominal surgery
- Not stoma
- Not constipation during admission
- Not intraperitoneal infection
Key exclusion criteria (3 listed)
- Having prolonged constipation and complications (such as decreased bowel sounds, and excessive distension)
- Order for regular laxatives or enemas
- Not meet inclusion criteria during follow-up
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
The frequency of total constipation, early-type constipation and late-type constipation
Time frame: Through study completion, an average of five months
During the study, patients in the intensive care unit with no bowel movements for four days were accepted as constipated. The ones without defecation for five days were evaluated in the early type constipation group, while the patients without defecation for six days or more were evaluated in the late-type constipation group.
5 secondary outcomes
he duration of stay in the intensive care unit
Time frame: Through study completion, an average of five months
the amount of gastric residual volume
Time frame: Through study completion, an avarage of five months
developing vomiting
Time frame: Through study completion, an average of five months
Level of white blood cells
Time frame: Through study completion, an average of five months
body temperature
Time frame: Through study completion, an average of five months
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 13 Jan 2023.
- Individual participant dataSharing planned: No
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
Arzu AKMAN YILMAZ, RN, PhD. principal investigator
Bolu Izzet Baysal University
Seyma OZDEMIR, RN,MSN. principal investigator
Pursaklar State Hospital
Esra OZDEMIR, MD. principal investigator
Bolu Izzet Baysal State Hospital
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 Constipation, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 6 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 13 Jan 2023. 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 Turkey (Türkiye). 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?
The frequency of total constipation, early-type constipation and late-type constipation (time frame: Through study completion, an average of five months). 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 13 Jan 2023.