HubBLe haemorrhoid trial finds great success

27 June 2013

UHB researchers are among the country’s leading recruiters for a study which could change the standard procedure for treating the painful condition of haemorrhoids.

The HubBLe haemorrhoid trial compares the effectiveness of two different treatments, one involving surgery under a general anaesthetic and the other a more minor procedure as an out-patient.

Haemorrhoids are caused by an enlarging of delicate tissues which normally provide cushioning around the anus. The condition is graded from one, the most minor, to four, the most serious.
Around one in three people will experience haemorrhoids during their life, potentially causing great pain and disruption to their lives.

HubBLe is a randomised trial, in which eligible, consenting patients with grade two or three haemorrhoids are randomised to receive either rubber band ligation (RBL), which is done as an out-patient procedure, or haemorrhoidal artery ligation (HAL), which involves surgery under anaesthetic.

After the procedure, the patient completes questionnaires about their current symptoms and wellbeing, and a follow-up visit will be carried out to assess the clinical success of the procedure. Further questionnaires are used to monitor the patient’s progress.

Since beginning recruitment to the trial in January, UHB has become the second highest and the fastest recruiter in the country. Consultant colorectal surgeon Mr Simon Radley is the Principal Investigator for the trial at QEHB.

Trials co-ordinator Amanda Davies, who works on the study with research nurse Mandip Narewal, says the successful pattern of recruitment is down to a number of factors: “We have the support of all the surgeons who see these patients, so we’re getting referrals of all the eligible patients. That really helps with recruitment and ensures as many patients as possible can take part in the trial.

“We have also made it as easy as possible for the consultants to identify and refer the patient, by preparing packs for every consultation room during the out-patient clinics,” she says.
“Then we handle all the follow-up work in subsequent clinics as well. So overall, we have a committed team of surgeons and we’ve set up a system which makes it easy to recruit and monitor the patients.”

The trial has a target of recruiting 350 patients across the country, including an expected 40 from QEHB. However, such is the success of the trial at QEHB that the hospital’s target could be increased.

The trial currently involves 14 sites across England and Scotland and is led nationally by Chief Investigator Mr Steven Brown, a consultant colorectal surgeon working from Sheffield Teaching Hospitals NHS Foundation Trust. The trial is funded by the National Institute for Health Research Health Technology Assessment Programme and is managed by the Sheffield Clinical Trials Research Unit, in the School of Health and Related Research (ScHARR), the University of Sheffield.

For more information about this and other research at QEHB, visit