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RecruitingTherapeutic use (Phase IV)Interventional

Oral laxatives after hip fracture surgery: A randomised controlled trial

After hip fracture surgery, many people experience uncomfortable constipation. This usually happens because of strong pain-relief medicines, anaesthetics, and being less active while resting in bed. Doctors routinely give laxatives to help, but it is not completely clear which type works best and quickest. This clinical trial compares different standard oral laxatives, such as macrogol, bisacodyl, or a combination of both. Researchers want to find out which treatment helps patients have a comfortable bowel movement within 72 hours (three days) after surgery. They will also measure how many people need extra 'rescue' treatments, such as suppositories or enemas, if the first laxative does not work. By identifying the most effective treatment, the study aims to improve comfort, speed up recovery, and prevent complications for future patients having hip surgery in the NHS.

At a glance

Status
Recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Odense University Hospital
Enrolment target
375
Start
04 Jul 2024

What is this study about?

Breaking a hip is a serious injury that usually requires surgery to repair or replace the joint. While recovering on a hospital ward, many patients find that their bowels stop moving normally. Constipation can cause painful bloating, nausea, and stomach cramps, making it much harder to get out of bed, start physiotherapy, and eat well.

This problem happens because the digestive system slows down after surgery. Strong painkillers (like morphine or codeine), anaesthetics, changes in diet, and staying in bed all contribute to sluggish bowels. To prevent severe constipation, doctors routinely prescribe oral laxatives. Common options include macrogol (which draws water into the stool to soften it) and bisacodyl (which gently stimulates the bowel muscles to push waste through).

This study compares these widely used medicines against each other. Doctors want to know whether macrogol, bisacodyl, or a mixture of both works best to produce a bowel movement within three days. They also want to see which option reduces the need for unpleasant 'rescue' treatments, such as enemas or suppositories. The findings will help hospitals provide better, more comfortable routine care for patients recovering from hip surgery.

Key takeaways

  • Tests common oral laxatives to find the best way to prevent constipation after hip surgery.
  • Compares standard NHS medicines: macrogol, bisacodyl, and combination treatments.
  • Takes place entirely during your normal hospital stay with no extra visits needed.
  • Aims to get bowels working within 72 hours and avoid the need for extra rescue treatments.
  • Taking part is voluntary and does not change your planned hospital discharge.

Who may be eligible?

This trial is open to adults who have recently had surgery in hospital for a broken hip (hip fracture). Because hip injuries are most common in older adults, the study includes people of all ages and does not exclude patients just because they have other ongoing health conditions.

To join, patients must be able to take medicines by mouth, such as tablets or liquid drinks. People who have a known bowel blockage, severe inflammatory bowel conditions, or medical reasons why they cannot take oral laxatives will not be able to participate.

Before taking part, the hospital healthcare team will review your health records to make sure the trial is safe and appropriate for your personal circumstances.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. You have had or are about to have surgery for a hip fracture.
  2. You are staying on a hospital ward for your recovery.
  3. You are able to take medicines by mouth (liquids or tablets).
  4. You do not have a bowel blockage or severe bowel disease.
Answer every question to see your result.

What does participation involve?

Taking part happens entirely while you are recovering in hospital after your hip operation, so you will not need any extra hospital visits. You will be placed into a treatment group by chance (randomly) to take one of the standard laxatives by mouth each day. Nurses and doctors will check in on you as part of your normal daily ward rounds. They will record when your bowels open and check if you feel bloated or uncomfortable. If your bowels do not open within 72 hours, or if you become very uncomfortable sooner, the medical team will step in and give you standard rescue medication to relieve the constipation. Your participation in the study usually ends after a few days once your bowel habits are back to normal or you are ready to be discharged.

Potential risks and benefits

Taking part may help you avoid uncomfortable constipation and recover more smoothly after your surgery, though there is no guarantee that one study medicine will work better than another. All medicines used in this study are already widely prescribed across the NHS. Possible side effects include mild stomach cramps, wind, feeling sick, or loose stools (diarrhoea). The ward team will monitor your symptoms closely and adjust your treatment if needed. Taking part is completely voluntary; you can choose to stop at any time without giving a reason, and your regular NHS medical care will not be affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Denmark

Common questions

What is a randomised trial?

It means a computer chooses which standard laxative you receive by chance, like flipping a coin. This ensures the results are completely fair and unbiased.

What happens if the study medicine does not work for me?

You will never be left in pain or discomfort. If your bowels have not opened within 72 hours—or earlier if the doctor decides it is needed—you will be given proven rescue medicine straight away.

Are the study laxatives experimental?

No. Both macrogol and bisacodyl are well-known, approved medicines that NHS doctors and pharmacists have used safely for many years.

Will taking part keep me in hospital for longer?

No. The study only runs during your usual hospital recovery period and will not delay your planned discharge date.

Can I leave the study if I change my mind?

Yes. You or your family can withdraw consent at any point, and your hospital team will continue to provide the best standard care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Oral laxatives after hip fracture surgery: A randomised cont…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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