A study comparing 2 operations for people with rectal cancer (HiP Study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer
Rectal cancer

Status:

Closed

Phase:

Other

This study is for people who are due to have surgery to remove the cancer in their rectum (back passage).  

More about this trial

Surgery is the usual treatment for rectal cancer. After your surgeon removes the part of the rectum with the tumour they can attach the colon (the large bowel) to the anus (the opening of the bowel to the outside of the body). This is called a colo-anal anastomosis Open a glossary item.

But sometimes this type of surgery is not suitable. This is usually because the surgeon is concerned that the join will not work properly and it could leak. In this situation you need to have another type of surgery and a colostomy Open a glossary item.

You have 1 of 2 types of operation:

  • Hartmann’s procedure (HP)
  • intersphincteric abdominoperineal excision (IAPE)

Both of these remove all the cancer in the rectum. But with an IAPE your anus is removed as well.

Both operations are done equally by surgeons. But we don’t know if one is better than the other. We also don’t know for sure if there is a difference in the complications people can have after surgery. For example, does 1 type have a higher rate of infection.

The main aims of this study are to see:

  • how many people have either a HT or an IAPE operation
  • what the side effects are after each operation

You will not get any direct benefit from taking part. But the doctors hope the results of this study will help decide which of the 2 operations is best. 

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

You may be able to join this study if all of the following apply.

  • You have an adenocarcinoma of your rectum
  • You are due to have surgery to remove all the cancer in your rectum
  • Your surgeon does not think you are suitable to have an anastomosis
  • You have had an MRI scan Open a glossary item to confirm the stage of your cancer
  • You are 18 years or older

You cannot join this study if any of these apply.

  • You are having surgery just to control symptoms (a palliative resection)
  • Your cancer may have ruptured (a tumour perforation)
  • You need to have surgery and a colostomy because your cancer has spread to the area between your rectum and anus (anorectal junction) or to your pelvic floor
  • You are pregnant

Trial design

 This study needs 200 people to take part.

Your surgeon will explain to you which type of operation they think is best for you. You have your operation as you would do whether you take part in this study or not.

The study team ask you to complete some questionnaires:

  • 1 questionnaire before your surgery
  • 2 questionnaires, 90 days after your operation.

 These ask questions about your quality of life

Hospital visits

You see the doctors and have some tests before your operation. The tests include:

  • a physical examination
  • a CT scan
  • blood tests
  • a heart trace (ECG Open a glossary item)

You have these tests whether you take part in the study or not.

You go to hospital for your operation. You are usually in hospital for about a week.

You see your surgeon a week or 2 weeks after you have gone home from hospital. They see how you are and ask about any side effects from the surgery. This is part of your routine care.

 As part of the study you will either be seen again 90 days after your operation, or your may be contacted by phone. Again this is to see how you are and if you have any side effects from the surgery. 

Side effects

Taking part in this study does not affect your operation or your care afterwards.

We have information about:

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Dale Vimalachandran

Supported by

Bowel Disease Research Foundation
Countess of Chester Hospital
NIHR Clinical Research Network: Cancer 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13871

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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