FAQs

  

What is an anal fistula?

An anal fistula is an opening next to the back passage, which connects with the anal canal. It may cause an abscess, pain, or discharge from the opening. If left untreated, the symptoms are likely to continue and the fistula may get more complicated and painful with time.

 

What are the treatments for anal fistula?

The standard treatment for anal fistula is surgery. Depending on what your surgeon believes is most appropriate for you, standard surgery could be: 1) cutting the fistula open to allow it to grow back with healthy tissue (fistulotomy), 2) closing the fistula by creating a flap of tissue in the back passage which covers the opening to the fistula (advancement flap), 3) placing a stitch into the fistula to slowly cut through it (cutting seton), or 4) closing the fistula tract using a cut in the back passage and a suture (LIFT procedure). Another possibility is to use a fistula plug, which is a relatively new treatment for anal fistula that involves the insertion of a biological material, made from pig collagen, into the fistula to encourage it to heal. 

 

What are the advantages and disadvantages of each treatment?

None of the above operations is a guaranteed cure for your fistula and each may be associated with complications. Current success rates with standard surgery vary between 50 – 80%. If the surgery involves cutting open the fistula (fistulotomy), this will leave an open wound which may take several weeks to heal. If a cutting stitch is used (seton), then further minor operations may be required to tighten the stitch as it cuts through the fistula. If a flap is used to close the fistula (advancement flap) then there will be a wound inside the back passage that may cause discomfort while it is healing. If a suture is used to close the fistula tract (LIFT procedure), then a wound will be left, which may take several weeks to heal. The main risk with standard surgery for anal fistula is that it can result in a change in continence (leakage or inappropriate passage of faeces from the back passage). This is usually minor in nature, although more serious problems with continence do sometimes occur.

The fistula plug is a simple operation to perform but does require a general anaesthetic. Unlike the standard surgical treatments there is no cutting of the muscle which controls continence, and therefore no risk to continence. However, the fistula plugs are expensive and their ability to heal fistulas is not accurately known. The current success rate is thought to be around 50% to 60%, and may be less than other standard treatments. If the plug fails to heal the fistula, it is likely that standard surgery would then be required. As the fistula plug is made from pig collagen, you should make your doctor aware if you have any cultural or religious objections to the use of pig material. If you are treated with a fistula plug you may experience a slight discharge from the fistula for a few weeks following insertion; this is normal and to be expected whilst the fistula is healing. As the plug is made from a natural collagen material it will dissolve, but this corresponds to the time taken for the fistula to heal, therefore the plug does not need to be removed once it has been put in place. There is a risk of further abscess formation following treatment, but this is the same as that following any treatment for an anal fistula. Some patients develop an allergic reaction to the plug. This can cause a skin rash which does settle on its own. Your healthcare team is trained to detect and treat any reactions that might happen. It is important that you let your surgeon know if you have any allergies or if you have reacted to any drugs or tests in the past.

 

What is the purpose of the FIAT Study?

In order to find out whether, on balance, the fistula plug is better than standard treatments, we are   comparing patients treated with the plug with similar patients who have been treated with standard surgery (fistulotomy, advancement flap, cutting seton, LIFT procedure). We will be assessing the ability of the plug to heal the fistula, any change in continence following treatment, and any change in quality of life as a result of treatment.

 

Why have I been invited to take part in FIAT?

Your surgeon will have invited you to take part in FIAT because you have an anal fistula that requires treatment to improve your symptoms. The FIAT study is trying to find out if treatment with the fistula plug is any better than the current standard surgical treatments. The FIAT study aims to include at least 500 people like you with anal fistula from hospitals throughout the UK. because you have an anal fistula that requires treatment to improve your symptoms. The study is trying to find out if treatment with the fistula plug is any better than the current standard surgical treatments. The study aims to include at least 500 people like you with anal fistula from hospitals throughout the UK.

 

Which treatment would I receive if i took part in the FIAT study?

So that we can find out which treatment is best, each person is put into a treatment group randomly (like tossing a coin). You have an equal chance of being allocated to the fistula plug or surgery groups. Neither you nor your doctor can choose which treatment you will receive. This is essential so that a fair comparison can be made between the different treatment groups. Dividing people into treatment groups in this way is what is called a 'randomised clinical trial' and it is the standard and most reliable way of comparing different treatments.

 

Do I have to take part?

No. Taking part in research is always voluntary. If you decide to take part you will be given this information sheet to keep, and will be asked to sign a consent form, but you are still free to withdraw at any time and without giving a reason. If you decide not to take part, then you don't have to give a reason why. Your specialist will be happy to talk through alternative options.

 

What will happen to me if I decide to take part in FIAT?

Most of the treatment you receive will be the same as you would have received even if you were not in a study. There are no extra clinic visits, blood tests, or operations required beyond your normal care. There is however some additional information that we would need to collect about your treatment and its effects.   You will be required to undergo an MRI (magnetic resonance imaging) scan and an examination under anaesthesia (EUA) to assess your fistula; both of these are routine for patients with high anal fistula so you would have them whether you were participating in FIAT or not. If your fistula is suitable for treatment with a fistula plug, you will be asked to participate in the study and will need to sign a Consent Form if you agree to take part. Your details will then be passed to the FIAT Study Office at the University of Birmingham.

You will then have your fistula treated by either surgery or insertion of a fistula plug. If you are allocated to standard treatment, it will be a matter for you and your doctor to decide which of the four types of surgery (fistulotomy, advancement flap, cutting seton or LIFT procedure) is best for you.   Once you have had your treatment we will need to collect information about any complications, whether the fistula has healed, any change in continence, and we will ask you to complete a short questionnaire on your quality of life. Most of this information will be collected at routine out-patient appointments, although some information may be collect by means of questionnaires sent by post. All information collected will be strictly confidential in the same way as your other medical records. As part of the study we will ask you to undergo a second MRI scan one year after your operation. This second MRI scan is not part of routine care and will be performed to determine whether or not the fistula has healed. After that, your progress would be followed-up once a year.

 

What care will I need after the operation?

You may be referred to your Practice Nurse or a District Nurse following your discharge from hospital. You may require simple pain killers for a few days following your operation. You may be provided with laxatives to help your bowels. If you are treated with a fistula plug you will be asked to refrain from physical exertion for 2 weeks following your operation to avoid accidentally dislodging the plug.

 

What are the possible benefits from taking part in FIAT?

We cannot promise the study will help you but your participation in the study will provide valuable information on the treatment of anal fistula and this will be used for the benefit of future patients.

There are no direct benefits from participating in the study. It is not clear whether fistula plugs heal fistulas better or worse than conventional treatment; it is one of the aims of the study to find this out. A potential benefit of the fistula plug is that it is not associated with any change in continence.

 

What if new relevant information becomes avaliable?

Sometimes we get new information about the treatment being studied. If this happens, your surgeon will discuss how this affects your care and your participation in the FIAT study. Your research doctor might consider you should continue in the study or withdraw. Either way, he/she will explain the reasons and arrange for your care to continue. If you decide to continue in the study he may ask you to sign an updated consent form. If the study is stopped for any other reason, your doctor would, again, tell you and arrange your continuing care. study. Your research doctor might consider you should continue in the study or withdraw. Either way, he/she will explain the reasons and arrange for your care to continue. If you decide to continue in the study he may ask you to sign an updated consent form. If the study is stopped for any other reason, your doctor would, again, tell you and arrange your continuing care.

 

What will happen if I don't want to carry on with this study?

You can decide not to continue with the study follow-up at any time but, if you do, we would still like your data to remain on file and be included in the final study analysis unless you request that they should not be.

 

What if something goes wrong? 

If you are harmed by taking part in this research project, there are no special compensation arrangements. If the harm is due to someone’s negligence, then you may have grounds for a legal action but you may have to pay for this. Whether or not you take part in the study, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms would be available to you. Taking part in the study would not affect your legal rights.

 

Will my taking part in the study be kept confidential?

If you decide to take part in FIAT, all information collected about you during the course of the trial will be kept strictly confidential in the same way as all of your other medical records. Information about you, your disease and progress will be sent by your doctors to the FIAT Study Office at the University of Birmingham Clinical Trials Unit (BCTU), on paper and electronically, where it will be securely stored under the provisions of the 1998 Data Protection Act. This will include a signed copy of your consent form. Your name and address will also be given to dedicated staff at the CTRU when you first enter the study, so that they can send Quality of Life questionnaires to your home address. Your GP, and the other doctors involved in your clinical care, will be notified of your participation in the FIAT trial and kept informed of your progress. We may use national records to track your progress, but otherwise all information about you and your treatment will remain confidential. , all information collected about you during the course of the trial will be kept strictly confidential in the same way as all of your other medical records. Information about you, your disease and progress will be sent by your doctors to the Study Office at the University of Birmingham Clinical Trials Unit (BCTU), on paper and electronically, where it will be securely stored under the provisions of the 1998 Data Protection Act. This will include a signed copy of your consent form. Your name and address will also be given to dedicated staff at the CTRU when you first enter the study, so that they can send Quality of Life questionnaires to your home address. Your GP, and the other doctors involved in your clinical care, will be notified of your participation in the trial and kept informed of your progress. We may use national records to track your progress, but otherwise all information about you and your treatment will remain confidential.

As we may also contact you by post to ask you to complete questionnaires asking about your progress, we will ask you to give us your permission to do so. With your permission, your relevant medical records may be inspected by authorised individuals from the BCTU and by the Department of Health (who are funding the study). They may also be looked at by regulatory authorities. The purpose of this is to check that the study is being carried out correctly.

 

What will happen to the results of the study? 

Once the trial has finished we will publish the results in a medical journal so that others can benefit. We will also publicise the results on the trial’s website www.bctu.ac.uk/fistula/.  No individual patients will be identified in any publications.  A copy of the published results of the trial will be sent to all participants who have participated in FIAT.  In line with clinical trial guidelines, at the end of the study, the date will need to be securely archived for a minimum of 15 years.  Arrangements for confidential destruction will then be made. 

Once the trial has finished we will publish the results in a medical journal so that others can benefit. We will also publicise the results on the trial’s website.

 

Who is organising and funding the research?

The FIAT study was developed by the Research and Audit Committee of the Association of Coloproctology of Great Britain and Ireland and is funded by the Heath Technology Assessment programme which is a part of the National Institute for Health Research (NIHR). The study is coordinated by the Clinical Trials Unit at the University of Birmingham and is sponsored by the University of Leeds. The research has been reviewed and approved by all of these organisations. There is no involvement of any companies other than providing the fistula plugs free of charge. study was developed by the Research and Audit Committee of the Association of Coloproctology of Great Britain and Ireland and is funded by the Heath Technology Assessment programme which is a part of the National Institute for Health Research (NIHR). The study is coordinated by the Clinical Trials Unit at the University of Birmingham and is sponsored by the University of Leeds. The research has been reviewed and approved by all of these organisations. There is no involvement of any companies other than providing the fistula plugs free of charge.

 

Who has reviewed the study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study has been reviewed and given favourable opinion by Trent Research Ethics Committee.

 

Where can I get further information?

If you have any further questions about anal fistula or clinical trials, please discuss them with your doctor or contact the FIAT study office at the University of Birmingham Clinical Trials Unit.

The FIAT study office is located at the University of Birmingham Clinical Trials Unit, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, B15 2TT.

Web address: www.bctu.bham.ac.uk; E-mail: FIAT@contacts.bham.ac.uk

 

             Thank you for your time in considering this study.