A trial looking at conventional versus keyhole surgery, plus ways to improve recovery, for people with bowel cancer (EnROL)

Who can enter

You can enter this trial if you

• Have been diagnosed with bowel cancer (colorectal cancer) at any stage
• Are due to have a planned operation for your bowel cancer
• Are at least 18 years old

You cannot enter this trial if you

• Have acute bowel obstruction
• Have surgery as an emergency
• Are unable to have painkillers into your spinal fluid (an epidural) due to medical reasons
• Are pregnant
• Have had surgery to your abdomen (a laparotomy) in the past and had complications (a surgeon on the trial will decide whether this applies to you)
• Are unable to have keyhole surgery (a surgeon will assess whether this type of surgery is suitable for you)

Trial design

This phase 3 trial will recruit 266 people who are due to have surgery for bowel cancer. If you are a patient at one of the recruiting hospitals, you may be asked to take part. If you are a patient at another hospital and you are interested in taking part, you could talk to your own surgeon about this. If your surgeon thinks you might be eligible, they can refer you to the surgeon at one of the recruiting hospitals.

There are two treatment groups in this trial and it is randomised. This means that you are put into one of two different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You have an equal chance of being in group 1 or 2.

If you are in group 1, you have keyhole (laparoscopic) surgery. If during your operation, your surgeon thinks that keyhole surgery is not the best and safest thing for you, they will change the operation to an open laparotomy.

If you are in group 2, you have an open laparotomy (conventional surgery).

Neither you nor the ward staff will know which surgery you’ve had until a week after your operation, when you will be told. Only the surgeon and theatre staff will know. The day after you have surgery, a member of the trial team will ask you 3 questions about the type of surgery you think you had. They will ask you the questions again before you go home from hospital.

Your abdominal wound will be covered with a dressing for a week so that the ward staff can’t tell which operation you’ve had. They will keep a close eye on the dressing, as they would normally. If the nurses think there is a problem with your wound the dressing can be removed and you will have appropriate treatment.

All patients will be part of the enhanced recovery programme. This includes

• Extra nourishing drinks before, during and after your operation
• Continuous painkillers into your spine (epidural analgesia) for at least 2 days and regular painkiller tablets
• Early removal of any surgical tubes after your operation, for example a urinary catheter (a tube that drains the urine from your bladder)
• Encouraging early activity and exercise after your operation

As part of this trial, you will be asked if the doctors can use some of the tissue samples of cancer removed during your operation. You will also be asked to provide extra urine samples and blood samples. The extra blood taken will be about 7 tablespoons. Where possible, this will be taken when you are having routine blood tests, so you do not have extra needles.

These tissue, blood and urine samples will be used to help researchers understand more about the effects of each type of surgery, the effects of treatment following surgery and why some people develop cancer in the first place. The samples may be stored and used in tests in the future that have not yet been developed. This part of the trial is optional. You do not have to agree to these extra samples if you don’t want to. You will still be able to take part in the trial.

You fill out a questionnaire before your operation and then at

• 4 weeks
• 3 and 6 months
• 1 year

You will probably fill out the first 4 questionnaires when you go for your hospital appointments. Or you can complete them at home and post back if they are not done for any reason. You will get your final questionnaire at 1 year by post. These questionnaires will ask you how you feel and whether you have used healthcare facilities, such as your GP or district nurse. This is called a ‘quality of life’ study.

Before your operation a nurse will ask you to carry out some simple exercises testing your balance, getting up from a sitting position and walking. They will record the results. They will repeat this at your hospital appointments at 4 weeks, then 3 and 6 months after your operation.

Hospital visits

Before your operation a doctor will examine you and you will have various tests. These tests will include

• CT scan, colonoscopy or barium enema of your bowel
• Scan of your chest and liver

If you have rectal cancer, you will have an MRI scan of your rectum. Most of the tests you have will be the same, whether you take part in this trial or not. There is information about what happens before a bowel operation on CancerHelp UK.

After your operation you will visit the outpatient department to see a doctor at

• 2 weeks
• 4 weeks
• 3 months
• 6 months

You may also have some tests such as scans and blood tests.

About one year after your surgery, you will complete a questionnaire asking you about how your abdomen looks.

Side effects

The doctors running this trial do not think you are at any extra risk from taking part. You would be having surgery for your bowel cancer, whether you take part in this trial or not. The likelihood of your cancer being cured is the same whether you have conventional surgery or keyhole surgery.

There is information about what to expect after your operation for bowel cancer and if you need a colostomy for bowel cancer on CancerHelp UK.