A Phase 4 interventional study of Bisacodyl and Macrogol 3350 and electrolytes in Hip Fractures, sponsored by Odense University Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 65 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Odense University Hospital · Phase 4, Interventional, and Treatment
To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives.
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.
822 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.
This study's planned enrollment of 375 is above the median of 90 across 529 interventional studies indexed under Hip Fractures.
Browse Hip Fractures studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients:
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
Drug: Macrogol 3350 and electrolytes
Enteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 2 tablets daily which is administered orally daily (in the evening) during admission
Drug: Bisacodyl
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
Drug: A combination of macrogol 3350 and electrolytes and bisacodyl
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
Also known as: 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
Also known as: 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
Also known as: A combination of Gangiden og Dulcolax
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
Time frame: 72 hours after surgery
Time to first bowel movements
Time to first bowel movements (in hours after finished surgery)
Time frame: hours up to 240 hours
Length of hospital stay
Length of hospital stay of the index admission from admission to discharge
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: daily up to 10 days
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Odense University Hospital