RecruitingNAINTERVENTIONAL

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

This study is for people having surgery for stomach cancer. Normally, during this type of operation, surgeons remove a fatty apron-like tissue called the omentum. This tissue plays a role in fighting infections and preventing other tummy problems. We want to find out if leaving the omentum inside the body during stomach cancer surgery is as good for patients as taking it out. Removing the omentum can sometimes lead to complications like infections or gut problems. This research will compare patients who have the omentum removed with those who have it left in, to see if keeping it makes any difference to their recovery and long-term health. The main goal is to check if survival rates are the same after three years.

At a glance

Status

Recruiting

Phase

Sponsor

Amsterdam UMC

Enrolment target

654

Start

01 Mar 2024

Estimated completion

01 Jan 2031

Stomach Neoplasm

What is this study about?

When you have an operation for stomach cancer, doctors usually perform a big surgery to remove the cancer. As part of this, they often take out a fatty sheet of tissue in your tummy called the omentum. They do this to make sure any cancer cells that might have spread to this area are also removed.

However, the omentum actually has some important jobs. It helps protect your body from infections and stops different parts of your tummy from sticking together, which can cause problems later. We've noticed that taking out the omentum during other types of surgery can sometimes lead to more infections or issues like blockages in the gut.

This study wants to see if we can safely leave the omentum in place for people having stomach cancer surgery. We don't have much strong evidence that removing it always helps patients live longer. By keeping the omentum, we hope to reduce the chances of complications after surgery without affecting how well patients recover from their cancer in the long run. We're mainly looking at whether people are still alive and well three years after their operation.

Key takeaways

This study looks at stomach cancer surgery.
It compares removing the omentum versus leaving it in place.
The omentum helps fight infection and prevent other tummy problems.
The main aim is to see if survival rates are the same after three years.
Taking part means you'll be randomly put into one of two treatment groups.
Patients are followed up for several years after surgery.

Who may be eligible?

This study is looking for adults aged 18 or over who have stomach cancer that can be removed with surgery. This includes certain stages of cancer where it hasn't spread too far. You'll need to be fit enough for a major operation, and your doctor will check this. You also need to be having a specific type of stomach removal surgery, whether it's done openly or using smaller cuts.

You won't be able to join if you have a very early stage of stomach cancer (T1N0) or if your cancer has spread so much that it needs many other organs removed. If you're pregnant, you can't take part. Also, if you've had certain other cancers recently, or if you've had previous surgery on your stomach or omentum, you might not be suitable for this study. Your doctor will make the final decision based on your overall health.

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?
Do you have stomach cancer that your doctor says can be removed by surgery?
Are you fit enough for a major operation?
Have you not had surgery on your stomach or omentum before (apart from a repair for a burst stomach)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups: one where the omentum is removed during your stomach cancer surgery, and another where it's carefully preserved. You won't get to choose which group you're in, similar to a coin toss. Your doctors will perform the surgery as planned, and they will collect information during and after your operation, such as details about any bleeding, complications, and your recovery in the hospital. You will be asked to complete several questionnaires about your quality of life at different times: before surgery, and then at 3, 6, 9, 12, and 24 months afterwards. We'll also keep track of your health for three to five years to see how you're doing long-term.

Potential risks and benefits

Taking part in this study may offer some benefits, as preserving the omentum could potentially lead to fewer complications after surgery, such as infections or gut problems, and a quicker recovery. However, there's also a risk that leaving the omentum in place might not be as effective in preventing the cancer from returning, though the study is designed to check if it's 'non-inferior' meaning at least as good. There's no guarantee of personal benefit, and all medical procedures carry risks. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (16)

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

University Medical Center of the Johannes Gutenberg University
Verified postcode
Mainz, Germany· Not yet recruiting
Azienda Ospedaliera Universitaria
Verified postcode
Siena, Italy· Not yet recruiting
Amsterdam UMC
Verified postcode
Amsterdam, Netherlands· Recruiting
Ziekenhuis Groep Twente
Verified postcode
Almelo, Netherlands· Not yet recruiting
Antoni van Leeuwenhoek
Verified postcode
Amsterdam, Netherlands· Not yet recruiting
Gelre ziekenhuis
Verified postcode
Apeldoorn, Netherlands· Not yet recruiting
Rijnstate ziekenhuis
Verified postcode
Arnhem, Netherlands· Not yet recruiting
Catharina Ziekenhuis
Verified postcode
Eindhoven, Netherlands· Recruiting
Universitait Medisch Centrum Groningen
Verified postcode
Groningen, Netherlands· Not yet recruiting
Zuyderland ziekenhuis
Verified postcode
Heerlen, Netherlands· Not yet recruiting
Medisch Centrum Leeuwarden
Verified postcode
Leeuwarden, Netherlands· Not yet recruiting
Leids Universitair Medisch Centrum
Verified postcode
Leiden, Netherlands· Not yet recruiting

Common questions

What is the omentum?

It's a large, fatty piece of tissue inside your tummy, like an apron, that helps protect your organs and fight infection.

Why might keeping the omentum be better?

It might lead to fewer problems after surgery, like infections or digestive issues, as the omentum has important roles in the body.

Will I get to choose if my omentum is removed?

No, you'll be randomly put into one of two groups, like flipping a coin, to ensure a fair comparison.

How long will I be followed up?

Researchers will keep track of your health and ask you to fill out questionnaires for up to three to five years after your surgery.

What is the main goal of this study?

To see if leaving the omentum during stomach cancer surgery is just as safe and effective as removing it, especially regarding survival rates after three years.

How to find out more

Suzanne S. Gisbertz, MD, PhD

s.s.gisbertz@amsterdamumc.nl 0031204444444 Official trial record

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