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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Postoperative recovery with the addition of long-acting NK1- and 5-HT3 receptor antagonists as prophylaxis for post-operative nausea and vomiting. A prospective, double-blind, randomized trial in laparoscopic surgery.

This study is checking if certain medicines can stop people feeling sick and throwing up after a type of stomach surgery called laparoscopic surgery (keyhole surgery). Feeling sick after surgery, called PONV, is very common and can make recovery difficult. Scientists are testing combinations of existing anti-sickness and new medicines to see if they work better together to prevent these unpleasant side effects. They want to find out if these medicines can help patients feel much better and recover more quickly after their operation. The study will look at how well patients feel overall, how much sickness they have, and if they need other medicines for pain or sickness. This research aims to improve comfort for patients after surgery.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Region Vaesternorrland, Umea University
Enrolment target
220
Start
15 Dec 2025

What is this study about?

Imagine you're having an operation, and one of the biggest worries is feeling really sick afterwards. That's a common problem called 'post-operative nausea and vomiting,' or PONV for short. It can make recovering from surgery much harder and less comfortable.

This study is trying to find the best way to prevent this sickness after a specific type of surgery, often called 'keyhole surgery' (doctors call it laparoscopic surgery). They are testing different combinations of medicines that are already known to help with sickness. The idea is to see if adding certain newer medicines to the usual treatment can make an even bigger difference, helping patients feel less sick and get back on their feet faster.

Researchers will closely watch how patients feel after their operations. They'll ask about sickness, pain, and their general well-being to understand which treatment works best. The goal is to find a better way to make recovery smoother and more comfortable for everyone who has these surgeries.

Key takeaways

  • The study aims to reduce sickness and vomiting after keyhole surgery.
  • It tests new combinations of anti-sickness medicines.
  • Both men and women aged 18 and over can join.
  • Participants will be monitored closely for several days after surgery.
  • The goal is to improve patient comfort and recovery after operations.

Who may be eligible?

This study is open to adults aged 18 years and older; there's no upper age limit. Both men and women can take part.

To be considered for this study, you would need to be scheduled for certain types of keyhole surgery, which is an operation where surgeons use small cuts and special instruments. The study team will check your medical history to make sure taking part is safe for you.

There might be other health conditions or medicines you are taking that would mean you couldn't join. The study team will go through all of this with you to make sure it's the right fit.

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. Are you 18 years old or older?
  2. Are you scheduled for a keyhole (laparoscopic) surgery?
  3. Are you generally in good health other than the condition needing surgery?
  4. Are you able to attend follow-up appointments, or track your symptoms for a few days after going home?
  5. Are you happy for your medical information to be used for research?
Answer every question to see your result.

What does participation involve?

If you decide to take part, study doctors will explain everything in detail. You would be randomly put into one of the treatment groups – like flipping a coin – to make sure the study is fair. One group might get the usual anti-sickness medicine, while others might get a new combination of medicines, and some might get a dummy treatment to compare against.

Before your surgery, you'll answer some questions about how you're feeling. After your operation, study staff will check on you regularly while you're in hospital, asking about sickness, pain, and how you're recovering. You'll also be asked to keep track of how you're feeling for a few days after you go home. Some people might also be invited for an interview about their experience a few weeks or months after their surgery. The total time you'd be involved, from before surgery to the last follow-up, could be up to 3 months.

Potential risks and benefits

Taking part in this study might help us find better ways to prevent sickness after surgery, which could benefit future patients. For you, there's a chance the treatment you receive could make your recovery more comfortable. However, as with any medicine, there's always a risk of side effects, such as headaches, tummy troubles like constipation or diarrhoea, or feeling tired. The study team will monitor you closely for any side effects. Remember, joining a study is always your choice, and you can withdraw at any time without affecting your medical care.

Locations (1)

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

Common questions

What is PONV?

PONV stands for Post-Operative Nausea and Vomiting, which means feeling sick and throwing up after an operation. It's a common side effect of surgery and anaesthetic.

What kind of surgery is this study for?

This study is for people having 'laparoscopic surgery', which is often called keyhole surgery, where doctors use small cuts to operate.

Will I know which medicine I'm getting?

No, this is a 'double-blind' study. This means neither you nor the study doctors will know which specific medicine you're receiving. This helps make the study fair and accurate.

What is the main thing the study wants to find out?

The main thing is to see how much different treatments improve your overall comfort and recovery on the first day after surgery, especially how much sickness you experience.

Is this a new type of medicine?

The study is looking at combinations that often include medicines already used for sickness, alongside some newer medicines or combinations to see if they work better together.

How to find out more

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

Discussion

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