ConstipationNCT07895316
Effect of a Constipation Prevention Checklist in Hip Surgery Patients
A study testing Constipation prevention and checklist monitoring in hip surgery patients in people with Constipation and Perioperative Nursing, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Constipation is a common postoperative problem in patients undergoing hip surgery and may be associated with immobilization, opioid analgesic use, and inadequate fluid and fiber intake. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation, Perioperative Nursing, Checklist
- What is being tested?
- Constipation prevention and checklist monitoring in hip surgery patients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who will undergo primary hip surgery due to a fracture,
- 18 years of age and older,
- Able to communicate in Turkish and possess the cognitive/communicative competence to respond to data collection tools,
- Without hearing problems that would impede communication (including those using hearing aids),
- Expected to be monitored for at least 3 days postoperatively,
- Patients who volunteer to participate in the study and provide written informed consent.
Who cannot join
- Patients with diagnosed chronic constipation, irritable bowel syndrome, or inflammatory bowel disease,
- Patients with a history of gastrointestinal surgery or a stoma,
- Patients with acute abdomen, suspected bowel obstruction, gastrointestinal perforation, active gastrointestinal bleeding, etc.,
- Patients with abdominal wall or abdominal clinical conditions that prevent abdominal massage,
- Patients with contraindications for mobilization and who have an external fixator,
- Patients with (Mini Cognitif Test) Mini-Cog <3,
Show all 10Show fewer
- Patients with active psychiatric illness that would prevent participation in the study or data collection process,
- Patients with American Society of Anesthesiologists IV or V (ASA IV or V),
- Patients whose surgery has been postponed,
- Patients who have undergone secondary hip surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University
Sivas
Ayşegül KAYA IMREK, +90 5070377665, aysegulkayagk@gmail.com
About this study
Official title: The Effect of Monitoring Constipation Prevention Practices in Hip Surgery Patients With the Perioperative Constipation Prevention Checklist on Patient Outcomes: A Randomized Controlled Study
Constipation is a common postoperative problem in patients undergoing hip surgery and may be associated with immobilization, opioid analgesic use, and inadequate fluid and fiber intake. Preventive interventions, including adequate fluid and nutritional intake, early mobilization, and abdominal massage, may help maintain bowel function. However, evidence regarding the effectiveness of a standardized checklist to guide and monitor these interventions throughout the perioperative period remains limited. This randomized controlled trial aims to determine the impact of monitoring the risk of perioperative constipation and prevention interventions using a standard checklist on bowel sounds, postoperative constipation severity, and quality of recovery in hip surgery patients. The checklist includes a systematic assessment of constipation risk and monitoring of preventive interventions, including fluid and nutrient intake, early mobilization, and abdominal massage. The findings may contribute to improving perioperative nursing care and constipation prevention in patients undergoing hip surgery.
- Conditions
- Constipation, Perioperative Nursing, Checklist, Orthopedic Disorder
- Being tested
- Constipation prevention and checklist monitoring in hip surgery patients
- Keywords
- preventing constipation, hip surgery, perioperative nursing, checklist, constipation, nursing care
- Medical subject headings
- Constipation, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constipation prevention and checklist monitoring in hip surgery patientsOther
Implementing interventions to prevent perioperative constipation and monitoring this with a checklist.
| Study group | Role | What they receive |
|---|---|---|
| Constipation prevention and checklist monitoring in hip surgery patients | Experimental | Participants will receive a multicomponent, non-pharmacological constipation prevention intervention guided by the Perioperative Constipation Prevention Checklist.Preoperatively, constipation risk and bowel sounds will be assessed.Postoperatively, bowel sounds will be assessed at 8, 16, and 24 hours.Early oral intake, daily fluid intake of 1.5-2.0 L, dietary fiber intake of 15-25 g/day, and early mobilization will be encouraged as clinically appropriate. The researcher will perform 15-minute abdominal massage sessions at 8, 16, and 24 hours after surgery. Bowel sounds will be assessed before and 30 minutes after each session.Constipation severity will be assessed on postoperative days 0, 1, and 2. Time to first flatus, time to first defecation, constipation occurrence, opioid use, and rescue treatment will be recorded.Quality of recovery will be assessed using the (Quality of Recovery)QoR-15 on the day of discharge.The checklist will document interventions and monitor bowel function. Receives: Other: Constipation prevention and checklist monitoring in hip surgery patients |
| rutine service operation | No intervention | Patients assigned to the control group will receive the institution's current standard perioperative care protocol. This includes monitoring patients according to routine clinical care procedures. Standard care will include mobilization appropriate to the patient's clinical condition and institutional practices, standard dietary applications, and, if deemed necessary, the use of laxatives as prescribed by the attending physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Defecation
The first postoperative bowel movement time for patients who underwent constipation prevention interventions and were monitored with a checklist.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start12 Oct 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Kaya İmrek, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895316
- Sponsor's protocol ID
- 2026-07/07
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data of participants will not be shared with other researchers. The study results will be published collectively through scientific publications and presentations, without disclosing the personal information of the participants.
Publications
Yue C, Liu Y, Zhang X, Xu B, Sheng H. Randomised controlled trial of a comprehensive protocol for preventing constipation following total hip arthroplasty. J Clin Nurs. 2020 Aug;29(15-16):2863-2871. doi: 10.1111/jocn.15299. Epub 2020 May 26.
PubMed 32320100
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Monitoring Constipation Prevention Practices in Hip Surgery Patients With the Perioperative Constipation Prevention Checklist on Patient Outcomes: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07895316
- Acronym / sponsor ID
- 2026-07/07
- Conditions
- Constipation, Perioperative Nursing, Checklist, Orthopedic Disorder
- Keywords
- preventing constipation, hip surgery, perioperative nursing, checklist, constipation, nursing care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
Constipation is a common postoperative problem in patients undergoing hip surgery and may be associated with immobilization, opioid analgesic use, and inadequate fluid and fiber intake. Preventive interventions, including adequate fluid and nutritional intake, early mobilization, and abdominal massage, may help maintain bowel function. However, evidence regarding the effectiveness of a standardized checklist to guide and monitor these interventions throughout the perioperative period remains limited. This randomized controlled trial aims to determine the impact of monitoring the risk of perioperative constipation and prevention interventions using a standard checklist on bowel sounds, postoperative constipation severity, and quality of recovery in hip surgery patients. The checklist includes a systematic assessment of constipation risk and monitoring of preventive interventions, including fluid and nutrient intake, early mobilization, and abdominal massage. The findings may contribute to improving perioperative nursing care and constipation prevention in patients undergoing hip surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constipation prevention and checklist monitoring in hip surgery patients | Experimental | Other: Constipation prevention and checklist monitoring in hip surgery patientsParticipants will receive a multicomponent, non-pharmacological constipation prevention intervention guided by the Perioperative Constipation Prevention Checklist.Preoperatively, constipation risk and bowel sounds will be assessed.Postoperatively, bowel sounds will be assessed at 8, 16, and 24 hours.Early oral intake, daily fluid intake of 1.5-2.0 L, dietary fiber intake of 15-25 g/day, and early mobilization will be encouraged as clinically appropriate. The researcher will perform 15-minute abdominal massage sessions at 8, 16, and 24 hours after surgery. Bowel sounds will be assessed before and 30 minutes after each session.Constipation severity will be assessed on postoperative days 0, 1, and 2. Time to first flatus, time to first defecation, constipation occurrence, opioid use, and rescue treatment will be recorded.Quality of recovery will be assessed using the (Quality of Recovery)QoR-15 on the day of discharge.The checklist will document interventions and monitor bowel function. |
| rutine service operation | No intervention | –Patients assigned to the control group will receive the institution's current standard perioperative care protocol. This includes monitoring patients according to routine clinical care procedures. Standard care will include mobilization appropriate to the patient's clinical condition and institutional practices, standard dietary applications, and, if deemed necessary, the use of laxatives as prescribed by the attending physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who will undergo primary hip surgery due to a fracture,
- 18 years of age and older,
- Able to communicate in Turkish and possess the cognitive/communicative competence to respond to data collection tools,
- Without hearing problems that would impede communication (including those using hearing aids),
- Expected to be monitored for at least 3 days postoperatively,
Key exclusion criteria (10 listed)
- Patients with diagnosed chronic constipation, irritable bowel syndrome, or inflammatory bowel disease,
- Patients with a history of gastrointestinal surgery or a stoma,
- Patients with acute abdomen, suspected bowel obstruction, gastrointestinal perforation, active gastrointestinal bleeding, etc.,
- Patients with abdominal wall or abdominal clinical conditions that prevent abdominal massage,
- Patients with contraindications for mobilization and who have an external fixator,
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 prevention and checklist monitoring in hip surgery patientsImplementing interventions to prevent perioperative constipation and monitoring this with a checklist. | Other | Constipation prevention and checklist monitoring in hip surgery patients |
Primary outcome
Time to First Defecation
Time frame: 3 days
The first postoperative bowel movement time for patients who underwent constipation prevention interventions and were monitored with a checklist.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 32320100Yue C, Liu Y, Zhang X, Xu B, Sheng H. Randomised controlled trial of a comprehensive protocol for preventing constipation following total hip arthroplasty. J Clin Nurs. 2020 Aug;29(15-16):2863-2871. doi: 10.1111/jocn.15299. Epub 2020 May 26.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual data of participants will not be shared with other researchers. The study results will be published collectively through scientific publications and presentations, without disclosing the personal information of the participants.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constipation prevention and checklist monitoring in hip surgery patients in people with Constipation and Perioperative Nursing, run by Cumhuriyet 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 10 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşegül KAYA IMREK (+90 5070377665, aysegulkayagk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Defecation (time frame: 3 days). 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 NCT07895316, 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 26 Oct 2026.