Which laxative to use after hip fracture surgery?
Oral Laxatives After Hip Fracture Surgery: A Randomised Controlled Trial
Researchers will try macrogol 3350, bisacodyl, and a half‑dose combination to see which best prevents constipation in people 65 and older after hip fracture surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 375 (estimated) |
| Ages | 65 Years to 110 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 2 sites (Kolding and 1 other locations) |
| Trial ID | NCT06455813 on ClinicalTrials.gov |
What this trial studies
This randomized, open-label trial will enroll about 375 patients aged 65 or older with acute hip fracture across two orthopedic departments in Southern Denmark. Participants are assigned in a 1:1:1 ratio to receive macrogol 3350 with electrolytes, bisacodyl 5 mg, or a combination of both at half doses. Laxatives are started after surgery and outcomes include rates and severity of postoperative constipation and related resource use such as length of stay and nursing time. The trial excludes patients with chronic constipation, current laxative use, severe cardiac or gastrointestinal disease, or inability to take oral medications.
Who should consider this trial
Good fit: Ideal candidates are Danish-speaking patients aged 65 or older undergoing acute hip fracture surgery at one of the participating hospitals who do not have chronic constipation or recent laxative use.
Not a fit: Patients with chronic constipation, ongoing laxative use at admission, severe inflammatory or obstructive gastrointestinal disease, severe heart failure, or inability to swallow tablets are excluded and unlikely to benefit from the tested regimens.
Why it matters
Potential benefit: If successful, the results could identify a simple, low-cost regimen that reduces postoperative constipation, shortens hospital stays, and lowers nursing workload.
How similar studies have performed: High-quality randomized trials comparing specific preventive laxative regimens after hip fracture surgery are lacking, so this trial addresses an evidence gap.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kolding and 1 other locations
- Hospital Lillebælt, Kolding Hospital — Kolding, Denmark (Recruiting)
- Odense University Hospital, Svendborg Hospital — Svendborg, Denmark (Recruiting)
Study contacts
- Study coordinator: Anton Pottegård
- Email: Anton.Pottegard@rsyd.dk
- Phone: 0045 28913340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.