Sorry, I forgot to say that the LUNA trial being held at the Clinical Trials Unit in Birmingham, England, is only able to accept patients with minor adhesions
(not major) adhesions,
In Friendship Kath Findlay
The UK Adhesion Society
INFORMATION FOR PATIENTS
Invitation to take part in the LUNA Study
Your consultant will have explained to you that you need a laparoscopy (a telescope examination of your pelvis under general anaesthetic) to try to find out the cause of your pelvic pain. If there is an obvious cause for the pain then we will treat it. But if there is no obvious cause then we would like to invite you to take part in a study looking at a simple procedure called LUNA, which may help cure your pain. This would be done at the same time as your laparoscopy. Participation in this study is entirely voluntary. Over 400 women, who like you have had persistent pelvic pain, will take part in the study. Half will be randomly allocated to have LUNA and the other half not to have this treatment. We will then compare the two groups to find out whether LUNA helps reduce pain. Women in the study will not be told which group they are in because we don't want this to influence how they feel after the operation. This is called 'blinding' and allows us to trust the results we obtain from the study.
What is LUNA?
LUNA stands for Laparoscopic Uterosacral Nerve Ablation. Some of the nerves coming from your womb are responsible for carrying the pain to the brain. LUNA cuts these nerves, using a small needle point electric current or a laser. This simple procedure is being used safely for other conditions, including endometriosis (a condition where the lining of the womb is found elsewhere in the pelvis and can cause pelvic pain). We need this trial of LUNA because doctors are not certain whether it will help women who don't have endometriosis.
Will LUNA help me?
We don't know yet. By taking part in this trial, you will help us find this out so that women in the future obtain the best treatment for their condition. You may benefit personally if you are allocated to have LUNA and this does prove to be the better treatment. In this case, women who were not allocated LUNA will be offered the option to have LUNA at a later date if they still have pelvic pain. On the other hand, LUNA may not improve the pain much, in which case it may be best not have this treatment.
Are there any other treatments for pelvic pain?
Several types of drugs are used for pelvic pain and you will probably have tried some of them already. You probably will have been referred to the gynaecology clinic because these treatments were not very effective. Whether or not you have LUNA, after your laparoscopy, you and your doctor will continue to have complete freedom to choose any drugs you wish for pain relief.
What happens during the laparoscopy?
You will be put to sleep under general anaesthetic and have air introduced into your abdomen by a small needle near your navel. This enables a fibre-optic telescope to be inserted via a second small cut beneath your navel. The consultant will examine your pelvic area and reproductive organs to see if you have any obvious reason for your pain, such as endometriosis or pelvic inflammatory disease. If this is the case, you will be treated for these conditions as appropriate.
If the consultant finds no obvious cause for your pain and the nerves that carry pain are accessible for surgery, then you will be randomly allocated LUNA or no LUNA. If you have LUNA, the nerves will be cut, using a thin surgical instrument inserted via a third incision in your lower abdomen. Whether or not you receive LUNA, this third incision will be made anyway. If we did not do this you would be able to tell which treatment you had had by counting the number of incisions and this might influence the way you feel about your pain after the operation.
The surgery should not result in any noticeable discomfort. The three cuts will be very small, approximately half a centimetre long, and may not even require stitches. If stitches are required, they may be self-absorbing and may not require removing later. There should be minimal scarring from these incisions under normal circumstances. Although LUNA is a safe procedure, like any other laparoscopic procedure, it is not without risks. These include possible damage to organs inside the abdomen at the site of LUNA. However, the chances of these complications are small.
What else will I be asked to do?
Before you have the surgery, you will be asked to complete a questionnaire to assess how much pain you are in and how this pain affects you. The same questionnaire will be sent to you at home 3, 6 12, 24 and 36 months after the surgery. You will not need to make any special trips back to the hospital. Even if you could not take part in the LUNA part of the trial, because you had other conditions or the nerves were not accessible for surgery, we would like you to complete the questionnaires at 6 and 12 months after the laparoscopy. The questions are designed to find out if there are any improvements in your pelvic pain following the laparoscopy.
There are four parts to the questionnaire - your assessment of your pelvic pain, what additional treatment you have taken for your pain, questions on how it affects your sexual relationships and some questions to determine your overall state of health and quality of life. The results of the trial will be reported once everyone in it has reached the one-year time point after surgery. We would, however, like you to complete the same questionnaires two and three years after the surgery to see if the effects of the treatment are long-lasting.
What are my rights?
You have the right to be given all important information about your condition, your treatment, the LUNA study and what you will be asked to do if you decide to take part. You should only agree to take part if you feel happy that you know enough about all these things. You do not have to take part in the study if you do not want to. If you decide not to, this will not affect the treatment you receive from your doctors and they will not think bad of you. If you do agree to take part, you are entitled to withdraw from the study at any time without having to give a reason. This will not affect your medical care in any way either.
Whether or not you take part in the study, you have the right to confidentiality of your medical records (although we will inform your GP that you are taking part in the LUNA study, unless you object). If you agree to take part, your doctor will send basic information about you and your disease to the study's central organisers at the University of Birmingham Clinical Trials Unit to allow the results to be analysed. The information will be kept securely and in strict confidence. The questionnaires will be identified only by a code number and will not be seen by your doctor. No named information about you will be published in the trial report.
If there are any questions, you can ask your doctor or gynaecologist. Alternatively you can contact:
LUNA Study Office, University of Birmingham, Clinical Trials Unit, Park Grange, 1 Somerset Road, Edgbaston, Birmingham B15 2RR Tel: 0121 687 2314
Drs K.S. Khan and P. Latthe, Department of Obstetrics & Gynaecology, Birmingham Women's Hospital, Metchley Park Road, Edgbaston, Birmingham B15 2TG Tel: 0121 472 1377 bleep 1504