A trial of robotic assisted keyhole surgery for cancer of the rectum (ROLARR)

This trial is looking at a robotic system to remove cancer of the back passage (rectal cancer).

The first treatment for rectal cancer is very often surgery. In the past, surgeons removed most rectal cancers by making a large cut in the tummy (abdomen). This is called open surgery. But more recently, they have developed keyhole surgery to remove small cancers from the bowel. This type of operation is called a laparoscopic resection.

They use a thin, flexible tube called a laparoscope, which contains a light and camera. Instead of making a large cut in your tummy, the surgeon can pass the laparoscope through a number of small cuts. An earlier study showed that keyhole surgery was as good as open surgery for removing bowel cancers.

But sometimes, when an operation is started using keyhole surgery, the surgeon may need to switch to open surgery. This happens in about 1 out of 4 keyhole operations for rectal cancer.

In this trial, surgeons are looking at a system called robotic assisted keyhole surgery. Using this system, the surgeon sits at a control unit a few feet away from the patient. They control the movement of a set of robotic surgical instruments, guided by a video camera.

The researchers want to find out if robotic assisted keyhole surgery is as good as, or better than, standard keyhole surgery for removing rectal cancers. They also want to see if it can reduce

The number of times surgeons need to switch to an open operation
Complications during and after surgery
The length of time people stay in hospital

Recruitment

Start 01/01/2011

End 30/04/2013

Phase

Other

You can enter this trial if you

Have been diagnosed with rectal cancer that your specialist thinks can be removed with keyhole surgery
Are fit enough to have a general anaesthetic
Are at least 18 years old

You cannot enter this trial if you

Have cancer that has spread into the surrounding tissue or to other parts of your body
Have anal cancer
Have had another cancer in the last 5 years apart from non melanoma skin cancer or superficial bladder cancer that has been successfully treated
Have inflammatory bowel disease
Are taking part in any other clinical trials looking at surgical techniques
Are pregnant

The trial will recruit about 400 people in different countries around the world. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

Half the people taking part have robotic assisted laparoscopic surgery. The other half have standard laparoscopic surgery.

During either type of surgery, the surgeon looks at images from the camera in your body. In this trial, the imaging from your operation will be videoed. It will not be possible to identify you from the video. It will only show pictures of what the camera sees inside your body during the operation.

The researchers will ask you to fill out some questionnaires before you have surgery and then 1 month and 6 months later. The questionnaires will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

You will see the trial doctors and have some tests before you start treatment. The tests will include some or all of the following (depending on local practice)

Physical examination
CT scan
MRI scan
Ultrasound scan

You will spend some time in hospital when you have your surgery. Your surgeon will tell you how long this is likely to be.

As well as your routine hospital appointments, you will see the trial team 1 month and 6 months after your surgery. After that, a member of the team will follow your progress once a year until 3 years after the last person joins the trial.

Before your operation, your surgeon will explain what you should expect afterwards. They will also talk to you about possible complications of surgery. These will be the same whether you have robotic assisted keyhole surgery or standard keyhole surgery. There is more general information about having surgery on CancerHelp UK.

After having an operation for a rectal cancer you may need a colostomy. Your surgeon will talk to you about the likelihood of this. There is information about what to expect after your operation for bowel cancer and if you need a colostomy on CancerHelp UK.

Location of trial

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
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