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Study on Preventing Constipation After Hip Fracture Surgery Using Bisacodyl and a Drug Combination for Post-Surgery Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have undergone surgery for a hip fracture. The study aims to find the best way to prevent constipation, a common issue after such surgeries, by using different types of laxatives. Two treatments are being tested: one containing bisacodyl, a chemical that helps stimulate bowel movements, and another combination treatment that includes simeticone, sodium hydrogen carbonate, potassium chloride, sodium chloride, sodium sulfate anhydrous, and macrogol 4000. These substances work together to ease bowel movements and relieve constipation.

The purpose of the study is to determine which treatment is more effective in preventing constipation after hip surgery. Participants will be randomly assigned to receive either the bisacodyl treatment or the combination treatment. Some participants may receive a placebo. The study will monitor the need for additional medication to manage constipation over a period of 72 hours after surgery.

Throughout the study, participants will take the assigned treatment orally, and their progress will be observed to see how well the treatments work in preventing constipation. The study will help doctors understand which laxative is more effective for patients recovering from hip fracture surgery, ultimately aiming to improve patient care and comfort during recovery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed for individuals who have undergone acute hip fracture surgery, are aged 65 years or older, and can speak and understand Danish.

  2. Step 2

    Medication administration

    Participants will receive oral laxatives to prevent constipation after hip surgery. The medications used include bisacodyl and a combination of simeticone, sodium hydrogen carbonate, potassium chloride, sodium chloride, sodium sulfate anhydrous, and macrogol 4000.

    The medications are administered orally. The specific dosage and frequency will be determined by the study protocol.

  3. Step 3

    Monitoring period

    Participants will be monitored for their response to the laxatives. The primary focus is on the need for additional medication within 72 hours, based on medical assessment.

  4. Step 4

    Completion of study

    The study is expected to conclude by December 31, 2024. Participants will be informed of the study's findings and any relevant outcomes.

Who can join the trial?

4 criteria

  • Patients who have had surgery for a hip fracture. A hip fracture is a break in the upper part of the thigh bone near the hip joint.
  • Patients must be from one of two orthopedic departments in hospitals located in the Southern Region of Denmark. Orthopedic departments are hospital units that specialize in treating bone and joint problems.
  • Patients must be aged 65 years or older.
  • Patients should be able to speak and understand Danish.

Who cannot join the trial?

3 criteria

  • Patients who have a **hip fracture** cannot participate in the study.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population, which means groups that might need special protection, are not included in this study.
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Investigated drugs

Oral Laxatives are medications used to help relieve constipation. In this trial, they are being tested to see how effective they are in preventing constipation after hip fracture surgery. These medications work by softening the stool or stimulating bowel movements, making it easier to pass stools and reducing discomfort for patients recovering from surgery.

What is already known about the treatment

Oral Laxatives – These medications are taken by mouth to help relieve constipation, especially after hip fracture surgery. They are commonly used in medical practice and are well-documented in medical literature for their effectiveness in promoting bowel movements. The main therapeutic indication is to prevent or treat constipation, which can be a common issue following surgery. At the molecular level, oral laxatives work by either drawing water into the intestines to soften stool or by stimulating bowel movements through increased muscle contractions. They are classified pharmacologically as gastrointestinal agents.

Investigated diseases

Hip Fracture – A hip fracture is a break in the upper part of the thigh bone (femur) near the hip joint. It often occurs in older adults due to falls or weakened bones from conditions like osteoporosis. The fracture can cause severe pain and difficulty moving the leg or standing. Over time, if not properly managed, it can lead to complications such as immobility or joint stiffness. Recovery typically involves a combination of rest, physical therapy, and sometimes surgery to repair the broken bone.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-513871-42-00Estimated enrolment375 patientsSponsorOdense University Hospital

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