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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Regionshospitalet Horsens Horsens Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
02.09.2024

Trial locations

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.

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 ID:
2024-513871-42-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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