Version 2,
March 2006
Patient Information Sheet
Randomised
Trial of Two Methods of Discectomy
You are being invited
to take part in a research study. Before you decide it is important for you to understand why the research
is being done and what it will involve. Please take time to read the following information carefully and
discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like
more information. Take time to decide whether or not you wish to take part. Thank you
for reading this.
Consumers for Ethics
in Research (CERES) publish a leaflet entitled ‘Medical Research and You’. This leaflet gives
more information about medical research and looks at some questions you may want to ask. A copy may be
obtained from CERES, PO Box 1365, London N16 0BW.
1. The purpose of the study.
The standard method of treatment of a prolapsed
(slipped) disc is microdiscectomy. This is an open procedure performed through a short incision of usually
5-8 cm. The nerve root is carefully moved out the way. Generally patients do extremely
well but there is some risk of scarring at the site of surgery. The surgery is done under a general anaesthetic
and patients remain in hospital over night.
Endoscopic discectomy
uses a different route of access to the spine. A cannula (hollow cylinder of 6.5mm diameter) is inserted
and through this is passed an arthroscope (camera tube). The disc is visualised and the protruding piece
excised. There is generally less scarring and a quicker recovery. The surgery is done
under a local anaesthetic (with the patient sleepy but not asleep) and generally patients are discharged the same day.
The aim of the study
is to determine which method is better in terms of result and which method has the lowest costs.
2. Why have I been chosen?
You have been chosen
as we believe that you will benefit from surgery. We hope to include all patients with straight-forward
‘slipped’ discs presenting for surgery.
3. Do I have to take part?
It is up to you
to decide whether or not to take part. If you do decide to take part you will be given this information
sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw
at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take
part, will not affect the standard of care you receive.
4. What will happen to me if I take part?
1. Before surgery you will be asked to complete some questionnaires and
sign consent forms for the surgery and the study.
2. You
will be admitted to hospital as would be the case for any other operation. You will be randomised by computer
to receive one of the two surgical treatments. There is no choice by the patient and the allocation will
not be changed within the trial by the surgeon.
3. The
two procedures take approximately the same length of time in the operating theatre (approximately 75 minutes).
The surgery will not delay your discharge nor alter your post-operative care. We anticipate that
you would be admitted either the morning of surgery (or day before if you live far away) and be discharged either later that
day or the following morning.
4. Following
surgery you will be reviewed at the out-patient clinic. You will be asked to complete further assessment
forms to see how well you have done (at 6 weeks, 3 months and 1 year)
5. What do I have to do?
We do not anticipate
any problems following your surgery. You will be asked to take ‘things’ fairly easy for 10
days, then we will start you on a course of physiotherapy. You will be able to swim and return to work
provided all is well, generally within 6 weeks of treatment.
6. What is the procedure being tested?
Endoscopic discectomy
is extremely popular in some European Centres. Indeed 80% of all spinal procedures are performed endoscopically
in one clinic in Munich. We were not using this technique at all in the UK until the summer of 2004 and
therefore we feel that its worth should be critically assessed.
7. What are the side effects
of any treatment received when taking part?
Both surgical procedures have some known risks. The most serious
is that of nerve root injury. As far as we can tell there is a similar risk with both techniques (<1%)
but you should be aware that any nerve injury is liable to be permanent. Nerve injury generally leads to
a loss of power in the foot and numbness, but you should be aware of the remote possibility of bladder paralysis (probably
<0.1%).
There are lesser
risks of infection (antibiotics given) and tear to the lining of the spinal canal known as a dural leak. Both
of these complications are usually easily treated, but a second surgical procedure might be required. These
risks are similar with the two techniques.
The spine is visualized
using X-rays during surgery. Dosages are similar in the two procedures and no additional radiation is given
by virtue of the study.
8.
What are the possible disadvantages and risks of taking part?
Endoscopic discectomy has a lesser track record than microdiscectomy.
There may be a slightly higher rate of recurrent disc prolapse (approximately 2% versus 1%), but this is outweighed
by lesser scar formation making a second operation much easier.
9.
What are the possible benefits of taking part?
We hope that both procedures will help you. Endoscopic discectomy
is performed under local anaesthetic. Recovery is much quicker and the scar is 7mm long rather than 5-8cm.
10.
What if new information becomes available?
If during the course of the trial we were to find out that one procedure
was markedly better than the other then we would advise you accordingly. However, our recent work would
suggest that this is not the case and that any benefits of one over the other are probably small, mainly being in relation
to relative cost and scarring.
11. What
happens when the research study stops?
We hope that you will be delighted with the results of your surgery.
We would like to follow your care during a two year period and possibly might contact you at 5 and 10 years.
12.
What if something goes wrong?
If you are harmed by taking part in this research project, there are no special
compensation arrangements. If you are harmed due to someone’s negligence, then you may have grounds
for a legal action but you may have to pay for it. Regardless of this, 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 will be available to you.
13. Will my
taking part in this study be kept confidential?
All information which is collected about you during the course
of the research will be
kept
strictly confidential. Any information about you which leaves the
hospital/surgery will have
your name and address removed so that you cannot be
recognised.
Your GP will be notified of your participation
in this trial and other medical practitioners not involved in the research, who may be treating you, may also be made aware
of the study.
14.
What will happen to the results of the research study?
The results will be published, probably in the medical journal
‘Spine’.
15.
Who is organising and funding the research?
Mr Gibson is the primary organiser of this project. He
is not being paid by any third party. Some research funding to cover administrative costs has been provided
by Quadrant Medical Ltd by way of a small grant. The instruments used in the trial have been bought by
Lothian Health.
16.
Who has reviewed the study?
The study is conducted
with the approval of the Lothian Local Research Ethics Committee 03.
17. Who should I contact for further
information?
Mr JNA Gibson, Consultant
Spinal Surgeon, The Royal Infirmary of Edinburgh
0131 242 3474 (Secretary)
Independent information may be sought from Mr P Statham, Consultant
Neurosurgeon, who is not associated with the study but aware of its aims. He may be contacted at the Dept. of Surgical Neurology,
The Western General Hospital, Edinburgh – Tel: 0131 537 1000.
Thank you for offering to take part in this
trial.
