Mr Raimondo Cervellione
Consultant Paediatric Urologist at The Royal Manchester Children’s Hospital, Manchester, UK
2010 Paediatric Urology Fellowship at Johns Hopkins Hospital, Baltimore, USA
2007 Paediatric Urology Fellowship, Manchester, UK
2004 CCST in Paediatric Surgery, University of Verona, Italy
1999 Basic Medical Qualification, University of Milan, Italy
Mr David Keene
Paediatric Surgical Registrar at the Royal Manchester Children’s Hospital, Manchester, UK
2007 MRCS RCSEng
2005 MRCPCH
2002 BMBS (University of Nottingham)
2000 BMed Sci (University of Nottingham)
Randomised study of early surgery in adolescent patients with varicocele
International Standard Randomised Controlled Trial Number Register
http://www.controlled-trials.com/ISRCTN57825419/
Parental information Sheet
We would like to give you information about the Manchester Varicocele study:
Who is it for?
The study is for boys aged 14 to 17 years old with a varicocele.
Why is it important?
Varicoceles are dilated veins around the scrotum and it is commonly associated with infertility in men.
Who is running the study?
The study is being run by Mr Keene (Registrar Paediatric Surgery) and Mr Cervellione (Consultant Paediatric Urologist)
What is known already about varicoceles
Current international guidelines suggest that boys with varicoceles should undergo surgery only if their testicle is not growing properly or if the varicocele is causing pain. However, following these guidelines can result in reduced fertility in adult life, as has been shown in a recent paper. At the moment the usual care for boys who have a varicocele and normal size of testicles is not to do surgery.
What question do we want to answer?
We would like to find out if early varicocele surgery is better than waiting until the testicle stops growing.
What does it involve?
Patients with a varicocele and normal sized testicles, will be randomly put into groups. The first group will follow the current guidelines and receive conservative treatment (no surgery). The second group will receive early surgery. With your permission we will let your GP know that your son has been entered into a study.
How long is the study?
Each patient will remain in the study until 18 years of age (between 1 and 4 years according to the age of the patient at enrolment).
Who will decide if my son gets surgery?
This must be decided randomly using a computer program, to make sure the study findings are valid. 50% of the patients in the study will have varicocele surgery and 50% will have conservative treatment (no surgery).
Why does my son have to produce a semen sample?
Each patient will be asked to produce a semen sample at the start and end of the study. This is essential to allow us to find out if surgery affects semen quality. This will also pick up problems with fertility early and allow plans to be made in advance.
What does semen testing involve?
Each patient will go to the andrology department in St Mary’s Hospital to provide a semen sample by masturbation. Your son should not masturbate or have sex for 3 to 4 days before the test. He will be given a small jar and shown to a private room to produce a semen sample.
What do the results of the semen testing mean?
The lab test measures the sperm count, movement of the sperm and how many have normal shapes. We will let you know the results of the sperm test at the next clinic appointment. If the sperm quality is poor the sample will be repeated once more to confirm the findings.
What is sperm banking?
Your son will be offered the option to bank part of the semen sample produced to allow for treatment of infertility in later life. Sperm banking needs both parental and teenager to consent. A blood test is needed before banking sperm to check patients are not carrying any blood infections. Local anaesthetic cream will be used to numb the skin before the blood test. The sperm samples are frozen in liquid nitrogen and can be stored for at least 10 years.
Is there any benefit for the patient?
This study has the potential to help us find out if early surgery in children with varicocele improves fertility. Your son will be carefully monitored for his condition by a team of specialists in this field until he is 18 years of age. Sperm banking will be offered for free.
Do I receive any payment?
There is no payment to parent or child as a result of being involved in the study. Travel expenses will not be reimbursed by the study.
What does surgery involve?
Varicocele surgery will be done under a general anaesthetic and involves tying off the dilated veins. It can be done as a day-case. The exact operation depends on which veins are leaking on the Doppler ultrasound scan. It is done using a key-hole surgery or with an incision in the groin.
Is there any risk with the surgery?
Generally the surgery is very safe and effective. The specific risks of varicocele surgery include: wound infection and bleeding (rare), some fluid can develop around the testicle (10-15% although the majority go away spontaneously) and there will be a scar. We will explain the operation in much more detail if your son is allocated to early surgery.
What happens if the patient does not get allocated early surgery?
Your son will be regularly reviewed in our clinic where we will check on the growth of the testicle. This is current standard management for varicoceles, which are not painful or do not affect the size of the testicle. If either of these conditions develop or the initial semen analysis shows a problem with the sperm quality your son will be treated with an operation as current guidelines recommend.