RecruitingOBSERVATIONAL

Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage

This research is investigating a new way to spot a common issue called anastomotic leakage (a leak at the join) after bowel surgery. This type of leak can happen in up to 20% of patients and can lead to serious health problems if not found quickly. The study uses a small, digital camera, called a rectoscope (LumenEye), to routinely check the surgical join in the days immediately following surgery. Researchers want to see if this method can detect leaks earlier, particularly in patients who might not show obvious signs of a problem. The goal is to improve patient outcomes by finding and treating these leaks faster, avoiding major re-operations, long-term health issues, and improving quality of life for those undergoing bowel surgery for conditions like bowel cancer.

At a glance

Status

Recruiting

Sponsor

Amsterdam UMC, location VUmc

Enrolment target

150

Start

01 May 2024

Estimated completion

01 May 2026

Anastomotic Leak Rectum

What is this study about?

This study is looking into a new way to check for a problem called an "anastomotic leak" which can happen after certain types of bowel surgery. When a surgeon removes a part of your bowel, they then join the two ends back together. This join is called an anastomosis. Sometimes, this join can leak, and it's a serious problem that can affect up to 1 in 5 patients who have this surgery.

Finding these leaks early is really important because if they're missed or found late, they can lead to more serious issues. These can include needing more operations, long-term health problems, or even a permanent stoma (where a part of the bowel is brought out to an opening on the tummy). Some leaks don't cause obvious symptoms right away, making them harder to spot. This study wants to see if using a special small camera, called a rectoscope (specifically a device called LumenEye), to regularly check the healing join straight after surgery can help doctors find these leaks sooner.

The main aim of this research is to see if routinely checking the surgical join with this camera can help doctors diagnose leaks faster. By detecting leaks earlier, even those without obvious symptoms, doctors hope to treat them more effectively, prevent serious complications, and ultimately help patients recover better and have a better quality of life after their surgery.

Key takeaways

Aims to find leaks after bowel surgery earlier.
Uses a special small camera (LumenEye) for checks.
Focuses on bowel joins near the back passage.
Hopes to prevent serious complications and improve recovery.
Participation is only for a short time after surgery.

Who may be eligible?

This study is looking for adults aged 18 or older who have recently undergone or will be undergoing specific bowel surgery that involves joining parts of their large bowel together, particularly those joins located up to 15 centimeters (about 6 inches) from the back passage. You'll also need to understand the specifics of the study, either in English or your local language, and be able to provide your written consent to take part.

There are just a couple of reasons why someone might not be able to join the study. If you find it difficult to lie in a specific position (left side with knees bent) that's needed for the camera check, then this study might not be suitable for you.

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 having bowel surgery where two parts of your bowel are joined together near your back passage?
Can you understand information about the study?
Can you comfortably lie on your left side for a quick examination?

Answer every question to see your result.

What does participation involve?

If you join this study, doctors will use a small, digital camera (called a LumenEye rectoscope) to check the area where your bowel was joined. This is done in the days immediately following your surgery. This check is usually quite quick and straightforward. The main thing the study is looking at is how quickly any potential leaks are found using this method. The total duration of your participation will be during your early recovery period in the hospital after your surgery.

Potential risks and benefits

Taking part in this study could potentially lead to earlier detection of a complication called an anastomotic leak, which might help prevent more severe problems and improve your recovery. The procedure of using the digital rectoscope is generally safe, but like any medical check, there's a small chance of discomfort. You are always free to decide to leave the study at any time, for any reason, without it affecting your medical care.

Locations (5)

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

Bordeaux Colorectal Institute Academy
Verified postcode
Bordeaux, France· Not yet recruiting
Humanitas Research Hospital
Verified postcode
Milan, Italy· Not yet recruiting
Amsterdam UMC
Verified postcode
Amsterdam, Netherlands· Recruiting
University Hospital Vall D'Hebron
Verified postcode
Barcelona, Spain· Not yet recruiting
Imperial College London
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is an 'anastomotic leak'?

It's when the new join made during bowel surgery doesn't seal perfectly and a small amount of bowel contents leaks out. It's a complication that doctors want to find and treat quickly.

What is a 'rectoscope'?

It's a small, flexible camera that doctors can use to look inside the lower part of the bowel, near the back passage. In this study, they're using a special digital one called LumenEye.

Why is early detection important?

Finding problems like leaks early means doctors can treat them faster, potentially preventing more serious health issues, bigger operations, or longer recovery times.

Will this camera check be painful?

The procedure is usually well-tolerated. Some people might feel a little discomfort, but it's generally quick and done gently by trained medical staff.

Does this study involve new medication?

No, this study is about using a camera to check the surgical site, not about testing new medicines. Your usual post-surgery care will continue as planned.

How to find out more

Roel Hompes, MD PhD

r.hompes@amsterdamumc.nl 020 - 444 4400 Official trial record

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