What Laxative Should be Used After Hip Fracture Surgery?
Oral Laxatives After Hip Fracture Surgery: A Randomised Controlled Trial
1 other identifier
interventional
375
1 country
2
Brief Summary
To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2024
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedStudy Start
First participant enrolled
October 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
July 31, 2025
July 1, 2025
2.3 years
May 3, 2024
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
72 hours after surgery
Secondary Outcomes (6)
Time to first bowel movements
hours up to 240 hours
Length of hospital stay
days up to 10 days
Number of patients who are readmitted at hospital
30 days
Number of patients who have emergency room visits
30 days
Constipation defined from the Bristol Stool Scale
daily up to 10 days
- +1 more secondary outcomes
Study Arms (3)
Macrogol 3350 and electrolytes.
ACTIVE COMPARATORPowder 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 COMPARATOREnteric 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 COMPARATORPowder 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
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Independent Research Fund Denmarkcollaborator
Study Sites (2)
Hospital Lillebælt, Kolding Hospital
Kolding, Denmark
Odense University Hospital, Svendborg Hospital
Svendborg, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carina Lundby
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2024
First Posted
June 12, 2024
Study Start
October 7, 2024
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
July 31, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share