RecruitingOBSERVATIONAL

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

This international study is exploring a new way of performing keyhole (laparoscopic) bowel surgery for conditions like bowel cancer or other non-cancerous growths. During keyhole surgery, gas is used to create space inside the tummy so surgeons can see and operate. This study focuses on using a special system called 'AirSeal' to maintain a very stable, low-pressure environment during the operation. Researchers hope this technique will lead to quicker recovery times, shorter hospital stays, and less pain for patients after their surgery. It's about making the standard keyhole surgery even better to help you get back to normal faster.

At a glance

Status

Recruiting

Sponsor

Bordeaux Colorectal Institute Academy

Enrolment target

300

Start

15 Dec 2023

Estimated completion

01 Sep 2025

Colorectal Surgery Benign or Malignant Rectal or Colon Tumors

What is this study about?

When you have keyhole surgery on your bowel, which is a common and very effective way to operate, surgeons need to inflate your tummy with gas. This creates a clear space for them to see what they're doing and use their instruments. This gas pressure is called pneumoperitoneum.

Over the years, doctors have found that keyhole surgery is generally better than traditional open surgery. Patients often have less pain, recover quicker, and have smaller scars. This study, called CROSS (Colorectal Surgery), is looking at how to make keyhole surgery even more comfortable and improve recovery further. They are specifically using a technique that keeps the gas pressure inside the tummy very low and stable throughout the operation. This is done with a special device called an AirSeal insufflator.

The main goal is to see if using this low, stable pressure during your keyhole bowel surgery can help you feel better sooner. This means potentially less pain after the operation, needing fewer strong pain medications, and being able to go home from the hospital quicker. Researchers are gathering information from many patients across different countries to understand if this specific method truly makes a positive difference to your recovery journey.

Key takeaways

The study explores a special low-pressure technique during keyhole bowel surgery.
Aims to reduce pain, need for painkillers, and hospital stay after surgery.
Involves patients having keyhole or robotic surgery for bowel conditions, using the AirSeal system.
Participation involves routine data collection; no extra tests or appointments.
Helps doctors understand how to improve patient recovery and comfort.
You can withdraw at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you generally need to be an adult aged 18 or over who is having keyhole or robotic surgery on your large bowel (colon or rectum) for a cancerous or non-cancerous condition. It's important that your specific surgery uses the 'AirSeal' system for maintaining low, stable pressure. You also need to be able to understand the study information and agree to take part.

There are certain situations where you wouldn't be able to join. For example, if you're having traditional open surgery, an emergency operation, or if you're pregnant or breastfeeding. You also can't participate if you have certain other serious health issues like pelvic sepsis, or if your circumstances make it difficult to follow the study's requirements.

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 keyhole (laparoscopic) or robotic surgery on your colon or rectum?
Is your surgery for a cancerous or non-cancerous growth?
Will your surgeon be using the 'AirSeal' system during your operation?
Are you not pregnant or breastfeeding?
Are you able to provide consent (agreement) to take part?

Answer every question to see your result.

What does participation involve?

This study is gathering information about your recovery after standard keyhole bowel surgery using a specific low-pressure technique. If you choose to take part, you won't be given any new medications or treatments. The surgery you receive will be the one your medical team already planned for you. The study involves collecting details about your experience, such as how long you stay in hospital, how much pain you feel, and how many painkillers you need after your operation. This information will be collected as part of your routine care, so there are no extra hospital visits or special tests just for the study. The total duration of your participation would cover your hospital stay and immediate recovery period, typically until discharge from the hospital.

Potential risks and benefits

The potential benefit of taking part is contributing to medical knowledge that could improve recovery for future patients undergoing keyhole bowel surgery. You are already having the surgery, and the study observes a specific technique that your surgeon is already planning to use. There are no additional direct risks to you from participating, as you wouldn't be undergoing any new or experimental procedures or tests beyond your planned surgery and follow-up. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (18)

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

Universitair Ziekenhuis
Verified postcode
Jette, Belgium· Recruiting
Hôpital Jean Minoz
Verified postcode
Besançon, France· Not yet recruiting
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
Verified postcode
Bordeaux, France· Recruiting
Hôpital Albert Michallon
Verified postcode
La Tronche, France· Not yet recruiting
Hôpital Bicêtre
Verified postcode
Le Kremlin-Bicêtre, France· Not yet recruiting
Hôpital Nord-Marseille
Verified postcode
Marseille, France· Recruiting
Clinique Hartmann
Verified postcode
Neuilly-sur-Seine, France· Not yet recruiting
Hopital Saint-Louis
Verified postcode
Paris, France· Not yet recruiting
Hôpital Saint-Antoine
Verified postcode
Paris, France· Not yet recruiting
Hôpital Européen Georges Pompidou
Verified postcode
Paris, France· Not yet recruiting
Hôpital Lyon Sud
Verified postcode
Pierre-Bénite, France· Recruiting
Hopital Charles Nicolle
Verified postcode
Rouen, France· Recruiting

Common questions

What is keyhole surgery?

Keyhole surgery (also called laparoscopic surgery) is a way of operating through small cuts in your tummy, using a camera and special tools, rather than one large cut.

What is 'low stable pressure' during surgery?

During keyhole surgery, gas is put into your tummy to give the surgeon space. 'Low stable pressure' means keeping this gas at a steady, lower level than sometimes used in other keyhole operations.

Will I get different treatment if I join the study?

No, you will receive the same high-quality care and surgery that your medical team has already planned for you. The study just gathers information about your usual care.

Will my information be kept private?

Yes, all your personal and medical information collected for the study will be handled confidentially and kept private to protect your identity.

How long will I be involved in the study?

Your involvement in the study will mainly cover your surgery and your recovery time in the hospital, and collecting information usually gathered for your medical records.

How to find out more

Quentin QD DENOST, Prof

q.denost@bordeaux-colorectal-institute.fr +33(0)5 47 50 15 75 Official trial record

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