RecruitingNAINTERVENTIONAL

Influence of Preoperative Immunomodulation by Oral Impact on Postoperative Complications Following Cystectomies & Nephrectomies

This study is investigating if a nutritional supplement, Oral Impact, can improve recovery for people having major bladder (cystectomy) or kidney (nephrectomy) surgery. Many studies have shown that this type of drink can help patients recover better after different kinds of operations by boosting their immune system. Major surgery can be very hard on the body, especially if a patient isn't well-nourished. The Oral Impact drink contains special ingredients like Omega-3 and vitamins, which are thought to help the body handle the stress of surgery and heal better. Researchers hope that patients who take Oral Impact before their operation will have fewer complications and a shorter stay in the hospital compared to those who don't.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Intercommunal Robert Ballanger

Enrolment target

214

Start

30 Nov 2022

Estimated completion

01 Jun 2025

Urological Manifestations

What is this study about?

When you have a big surgery, like an operation on your bladder or kidneys, it can be very tough on your body. Your body needs to be strong and well-prepared to heal properly afterwards. Sometimes, people might not be getting all the nutrients they need, which can make it harder for them to recover and could lead to problems after surgery.

This study is looking at a special nutritional drink called Oral Impact. This drink is designed to give your body extra support, with ingredients that help your immune system. It's like giving your body a pre-surgery boost to help it cope with the stress of the operation and fight off potential issues later. We already know that similar drinks have helped patients recover from other types of surgery, like those on the digestive system or heart.

Historically, our hospital noticed that some patients having major bladder or kidney surgery were facing more complications than expected, even with excellent surgical care. We think that making sure patients are as strong and well-nourished as possible before their operation might be a key part of improving their recovery. This study aims to find out if giving Oral Impact before these specific urological surgeries can make a real difference in how well patients recover, leading to fewer problems and a quicker return home.

Key takeaways

This study investigates a nutritional drink's effect on major bladder/kidney surgery recovery.
It aims to reduce complications and shorten hospital stays after surgery.
The drink, Oral Impact, contains immune-boosting ingredients.
Previous studies show similar drinks helped recovery in other surgery types.
Participation involves taking the drink for 7 days before surgery.

Who may be eligible?

To be considered for this study, you need to be 18 years old or older and be scheduled for a major operation on your bladder (cystectomy) or kidney (nephrectomy), or other similar major abdominal surgery involving the urinary system. You'll also need to freely agree to take part and understand what the study involves, and be covered by a UK social security scheme.

However, some things would mean you can't join the study. This includes having a condition that affects your immune system, like HIV infection, or needing urgent surgery. If you're having an operation to treat a long-term urinary tract infection, you also wouldn't be able to participate. You also can't be in the study if you're unable to take the Oral Impact drink for seven days before your surgery, have an unstable mental health condition, or get COVID-19 during your hospital stay after surgery.

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.

Are you 18 years old or older?
Are you scheduled for major bladder, kidney, or similar urological surgery?
Can you commit to taking a nutritional drink for 7 days before surgery?
Do you *not* have an immune system condition (like HIV)?
Is your scheduled surgery *not* an urgent emergency?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to drink the Oral Impact supplement for seven days leading up to your scheduled surgery. During your hospital stay and after your operation, the medical team would carefully monitor your recovery, just as they would for any patient undergoing similar surgery. They would be looking at how quickly you heal and if you experience any complications. There are no additional visits or assessments beyond your standard surgical care, but the researchers will be collecting information from your medical records about your recovery and length of hospital stay.

Potential risks and benefits

Participating in this study might offer the benefit of potentially having fewer complications and a faster recovery after your surgery, although this is not guaranteed. As with any medical intervention, there could be side effects from taking the nutritional drink, though these are generally mild. You are always free to change your mind and withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (2)

CHI Robert Ballanger
Verified postcode
Aulnay-sous-Bois, France· Recruiting
CHI André Grégoire
Verified postcode
Montreuil, France· Recruiting

Common questions

What is Oral Impact?

Oral Impact is a special nutritional drink containing various nutrients, like Omega-3 and certain vitamins, designed to support your body's immune system and help it prepare for and recover from surgery.

Why is this study important?

This study is important because it could help us understand if giving patients a specific nutritional boost before major bladder or kidney surgery can improve their recovery, reduce complications, and help them get home sooner.

Will I know if I'm getting Oral Impact or not?

In some studies like this, participants are randomly assigned to either receive the treatment or a control. Your doctor can explain the specific details of how this study is set up regarding who receives the supplement.

What kind of complications are you looking to reduce?

Researchers are hoping to see a reduction in common problems that can happen after surgery, which could include infections, issues with wound healing, or other difficulties that might lead to a longer hospital stay.

Does taking Oral Impact replace regular food?

No, Oral Impact is a supplement designed to provide extra nutrients, not to replace your regular meals. It works alongside a healthy diet to prepare your body for surgery.

How to find out more

Serge Ndoko, MD

serge.ndoko@ght-gpne.fr 01.49.36.70.41 Official trial record

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