NCT06455813 What Laxative Should be Used After Hip Fracture Surgery?
| NCT ID | NCT06455813 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Odense University Hospital |
| Condition | Hip Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 375 participants |
| Start Date | 2024-10-07 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 375 participants in total. It began in 2024-10-07 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Pregnant women can not be included but the women are expected to be postmenopausal why pregnancy test are not performed
Contact & Investigator
Carina Lundby
STUDY DIRECTOR
Odense University Hospital
Frequently Asked Questions
Who can join the NCT06455813 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 110 Years, studying Hip Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06455813 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06455813 currently recruiting?
Yes, NCT06455813 is actively recruiting participants. Contact the research team at Anton.Pottegard@rsyd.dk for enrollment information.
Where is the NCT06455813 trial being conducted?
This trial is being conducted at Kolding, Denmark, Svendborg, Denmark.
Who is sponsoring the NCT06455813 clinical trial?
NCT06455813 is sponsored by Odense University Hospital. The principal investigator is Carina Lundby at Odense University Hospital. The trial plans to enroll 375 participants.