Results of five year trial published

Results of five year trial published

Results of a five year trial on haemorrhoids (commonly known as piles), jointly sponsored by NHS Highland and the University of Aberdeen, have this week been published in The Lancet, one of the world's oldest and best known medical journals.

The trial, which is the largest of its kind, was run by Professor Angus Watson, consultant colorectal surgeon for NHS Highland and Honorary Clinical Senior Lecturer at the University of Aberdeen, was funded by the National Institute for Health Research through its Health Technology Assessment programme.

Professor Watson explained that the study team recruited 777 patients from 32 UK hospitals (England, Scotland and Wales) in order to do a comparison between the two most common surgical treatments for haemorrhoidal disease - stapled haemorrhoidopexy or traditional excisional surgery.
He said: “Haemorrhoids are swellings in blood vessels that lie at the top of the anal canal. They are very common and cause symptoms such as bleeding, pain, swelling and itch.

“There are several treatments available for haemorrhoids. These treatments start with simple measures, which can be done in the community, such as avoiding straining when on the toilet and increasing the amount of fruit and fibre in the diet. Creams and suppositories are also available to help symptom relief. When symptoms do not settle with these measures, patients are often referred up to the hospital for treatment.

“Approximately 25,000 surgical operations are done each year in England and Wales to help control these symptoms.”

Surgical operations for piles include two commonly performed procedures, both of which are performed under general anaesthetic. A stapled haemorrhoidopexy (SH) involves using a specialist disposable surgical stapler that removes a ring of tissue above the haemorrhoids to reduce the swelling and the blood supply to the piles. The second one is a traditional excisional surgery (TH) which uses electro-cautery to physically cut out the haemorrhoids.

Professor Watson added: “There has been doubt as to which surgical procedure is better at controlling symptoms and we are uncertain as to how these operations affect a patient’s quality of life after surgery.

“There was very little robust economic data as to how much the surgeries cost the NHS or the patients. There were, therefore, a number of key questions that need answering. The trial was designed to answer these questions.”

The eTHoS (either Traditional Haemorrhoidectomy or Stapled) trial compared the two procedures by conducting a randomised controlled trial (RCT) (random allocation of patients to one treatment or another) to help answer some of the gaps in our knowledge.

The trial showed that over 24 months the quality of life experienced by patients after surgery was better after TH. In addition the cost of the treatment was cheaper by £337 and patients who had received the TH had fewer pile symptoms over two years.

Patients who had SH were almost twice as likely to report the presence of pile symptoms compared with patients who had undergone TH. Continence scores were better in the TH arm of the study. SH was less painful during the first three weeks after surgery but after this, the use of pain control medication (analgesia) and the presence of pain was equal between the two groups of patients.
Patients returned to normal activities at the same rate after their operations and the majority of both operations were done as day cases and took the same length of time to do.

Professor Watson said: “If the results of the trial are adopted across the UK and further afield, patients will have better results after traditional surgery and its use may potentially save the NHS millions of pound every year.”

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