Hip FracturesPhase 4NCT06455813
What Laxative Should be Used After Hip Fracture Surgery?
A Phase 4 study testing Bisacodyl, Macrogol 3350 and electrolytes and A combination of macrogol 3350 and electrolytes and bisacodyl in people with Hip Fractures, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Bisacodyl, Macrogol 3350 and electrolytes and A combination of macrogol 3350 and electrolytes and bisacodyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 2 sitesDenmark
- Study dates
- 7 Oct 2024to 1 Aug 2026
- Phase
- Phase 4
- 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 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Acute hip fracture surgery patients from one of two orthopedic departments from hospitals in the Southern Region of Denmark.
- Age≥ 65 years
- The patients should be able to speak and understand Danish.
Who cannot join
- Patients:
- with known chronic constipation (defined from Wexner constipation score)
- with known use of laxatives at admission
- who participate in other similar clinical studies
- who is terminally ill
- who is restraint
Show all 16Show fewer
- who is in isolation
- with severe heart disease defined as New York Heart Association (NYHA) III og IV
- with severe chronically inflammatory bowel disease
- with acute abdominal surgical conditions, eg. ileus, obstruction or perforation
- with dysphagia where the patient can not swallow tablets/oral liquids
- with toxic megacolon
- with gastric emptying disorder
- with severe electrolyte disorder (P-kalium: < 2.5 mmol/l og P-natrium: <125 mmol/l)
- Allergies to the ingredients
- Pregnant women can not be included but the women are expected to be postmenopausal why pregnancy test are not performed
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hospital Lillebælt, Kolding Hospital
Kolding
Odense University Hospital, Svendborg Hospital
Svendborg
About this study
Official title: Oral Laxatives After Hip Fracture Surgery: A Randomised Controlled Trial
To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives.
Read the detailed description
Background:
Acute constipation is very common in connection with major operations. Constipation is a complication that can prolong hospital stays, increase nursing time and healthcare costs. Up to 70% experience constipation after surgery for a hip fracture. Prevention of constipation is considered an important part of treatment after hip surgery, but although the use of anti-constipation drugs is widespread, there are no studies of sufficient quality to show how and with what means constipation is best treated. For the same reason, in Denmark there is great variation in the approach to preventive treatment - and thus also the treatment result.
Aim:
The aim is to investigate how to prevent constipation best after hip surgery using laxatives.
Method, design, intervention og investigation procedures:
The project is a randomized controlled trial in ratio 1:1:1, where the patients assigned to two different orthopedic surgery departments are assigned to either have one of two drugs (bisacodyl, macrogol) or both types of anti-constipation drugs. It is calculated that 375 patients will be included in the trial, i.e. 125 patients in each group. It is expected that patients will be evenly included distributed between two hospitals.
The patients will respectively be given macrogol 3350 and electrolytes (ATC code A06AD65) which is administered as the content of 2 sachets, Bisacodyl (ATC code A06AB02) 5 mg, 2 tablets or a combination of both in half the dose.
All laxatives are administered orally in the evening on the day of surgery (the next standard administration time at 10 pm) and it is known to both patients and staff which trial medication each patient is receiving. The patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristalsis-promoting agents Bisacodyl 5 mg, 2 tablets. The patients stay in the trial and get the trial medication they are assigned to unless an orthopedic surgeon assesses otherwise.
- Conditions
- Hip Fractures
- Being tested
- Bisacodyl, Macrogol 3350 and electrolytes, A combination of macrogol 3350 and electrolytes and bisacodyl
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisacodylDrug
Also called Dulcolax
The patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristaltic-promoting agents
Macrogol 3350 and electrolytesDrug
Also called Gangiden
The patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristaltic-promoting agents
A combination of macrogol 3350 and electrolytes and bisacodylDrug
Also called A combination of Gangiden og Dulcolax
The patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristaltic-promoting agents
| Study group | Role | What they receive |
|---|---|---|
| Macrogol 3350 and electrolytes. | Active comparator | Powder for oral solution in sachet Macrogol 3350 and electrolytes (ATC code A06AD65) which is administered orally as the content of 2 sachets daily (in the evening) during admission Receives: Drug: Macrogol 3350 and electrolytes |
| Bisacodyl | Active comparator | Enteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 2 tablets daily which is administered orally daily (in the evening) during admission Receives: Drug: Bisacodyl |
| A combination of macrogol 3350 and electrolytes and bisacodyl | Active comparator | Powder for oral solution in sachet macrogol 3350 and electrolytes (ATC code A06AD65) which is administered orally daily (in the evening) as the content of 1 sachet given in combination with enteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 1 tablet orally daily (in the evening) during admission Receives: Drug: A combination of macrogol 3350 and electrolytes and bisacodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who will need rescue medication (Bisacodyl)
Part of patients in each group who needs rescue medication after 72 hours or rescue medication before 72 hours on behalf of a medical assessment
Measured: 72 hours after surgery
Secondary outcomes (6)
Time to first bowel movements
Time to first bowel movements (in hours after finished surgery)
Measured: hours up to 240 hours
Length of hospital stay
Length of hospital stay of the index admission from admission to discharge
Measured: days up to 10 days
Number of patients who are readmitted at hospital
The part of patients who are readmitted at hospital 30 days after discharge hospital
Measured: 30 days
Number of patients who have emergency room visits
The proportion of patients who have emergency room visits within 30 days of discharge hospital
Measured: 30 days
Constipation defined from the Bristol Stool Scale
constipation defined from the Bristol Stool Scale with type 1-7 where type 1 is constipation and type 7 is diarrhea and use/no use of rescue medication (bisacodyl)
Measured: daily up to 10 days
Constipation score
Calculated score based of The Patient Assessment of Constipation symptoms Questionnaire from 0-48 where 48 is most severe constipation and use/no use of rescue medication (bisacodyl)
Measured: daily up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start7 Oct 2024
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Odense 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Independent Research Fund Denmark
- Responsible party
- Sponsor
- Investigators
- Carina Lundby, Study director, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455813
- Sponsor's protocol ID
- Laxatives26092019
- Status last verified
- Oct 2026
- First submitted
- 3 May 2024
- Last updated
- 23 Oct 2026
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Laxatives After Hip Fracture Surgery: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06455813
- Acronym / sponsor ID
- Laxatives26092019
- Conditions
- Hip Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Independent Research Fund Denmark
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 12 Jun 2024 (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.
To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives.
Detailed description
Background:
Acute constipation is very common in connection with major operations. Constipation is a complication that can prolong hospital stays, increase nursing time and healthcare costs. Up to 70% experience constipation after surgery for a hip fracture. Prevention of constipation is considered an important part of treatment after hip surgery, but although the use of anti-constipation drugs is widespread, there are no studies of sufficient quality to show how and with what means constipation is best treated. For the same reason, in Denmark there is great variation in the approach to preventive treatment - and thus also the treatment result.
Aim:
The aim is to investigate how to prevent constipation best after hip surgery using laxatives.
Method, design, intervention og investigation procedures:
The project is a randomized controlled trial in ratio 1:1:1, where the patients assigned to two different orthopedic surgery departments are assigned to either have one of two drugs (bisacodyl, macrogol) or both types of anti-constipation drugs. It is calculated that 375 patients will be included in the trial, i.e. 125 patients in each group. It is expected that patients will be evenly included distributed between two hospitals.
The patients will respectively be given macrogol 3350 and electrolytes (ATC code A06AD65) which is administered as the content of 2 sachets, Bisacodyl (ATC code A06AB02) 5 mg, 2 tablets or a combination of both in half the dose.
All laxatives are administered orally in the evening on the day of surgery (the next standard administration time at 10 pm) and it is known to both patients and staff which trial medication each patient is receiving. The patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristalsis-promoting agents Bisacodyl 5 mg, 2 tablets. The patients stay in the trial and get the trial medication they are assigned to unless an orthopedic surgeon assesses otherwise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Macrogol 3350 and electrolytes. | Active comparator | Drug: Macrogol 3350 and electrolytesPowder for oral solution in sachet Macrogol 3350 and electrolytes (ATC code A06AD65) which is administered orally as the content of 2 sachets daily (in the evening) during admission |
| Bisacodyl | Active comparator | Drug: BisacodylEnteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 2 tablets daily which is administered orally daily (in the evening) during admission |
| A combination of macrogol 3350 and electrolytes and bisacodyl | Active comparator | Drug: A combination of macrogol 3350 and electrolytes and bisacodylPowder for oral solution in sachet macrogol 3350 and electrolytes (ATC code A06AD65) which is administered orally daily (in the evening) as the content of 1 sachet given in combination with enteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 1 tablet orally daily (in the evening) during admission |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Acute hip fracture surgery patients from one of two orthopedic departments from hospitals in the Southern Region of Denmark.
- Age≥ 65 years
- The patients should be able to speak and understand Danish.
Key exclusion criteria (16 listed)
- Patients:
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 |
|---|---|---|
| BisacodylAlso: DulcolaxThe patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristaltic-promoting agents | Drug | Bisacodyl |
| Macrogol 3350 and electrolytesAlso: GangidenThe patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristaltic-promoting agents | Drug | Macrogol 3350 and electrolytes. |
| A combination of macrogol 3350 and electrolytes and bisacodylAlso: A combination of Gangiden og DulcolaxThe patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristaltic-promoting agents | Drug | A combination of macrogol 3350 and electrolytes and bisacodyl |
Primary outcome
The proportion of patients who will need rescue medication (Bisacodyl)
Time frame: 72 hours after surgery
Part of patients in each group who needs rescue medication after 72 hours or rescue medication before 72 hours on behalf of a medical assessment
6 secondary outcomes
Time to first bowel movements
Time frame: hours up to 240 hours
Length of hospital stay
Time frame: days up to 10 days
Number of patients who are readmitted at hospital
Time frame: 30 days
Number of patients who have emergency room visits
Time frame: 30 days
Constipation defined from the Bristol Stool Scale
Time frame: daily up to 10 days
Constipation score
Time frame: daily up to 10 days
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 23 Oct 2026.
- 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.
Carina Lundby study director
Odense University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisacodyl, Macrogol 3350 and electrolytes and A combination of macrogol 3350 and electrolytes and bisacodyl in people with Hip Fractures, run by Odense 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 16 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 23 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 proportion of patients who will need rescue medication (Bisacodyl) (time frame: 72 hours 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 23 Oct 2026.