The HubBLe Trial: Haemorrhoidal Artery Ligation (HAL) versus Rubber Band Ligation (RBL) for haemorrhoids | Not Recruiting
The HubBLe Trial: Haemorrhoidal Artery Ligation (HAL) versus Rubber Band Ligation (RBL) for haemorrhoids
HubBLe
Trial Source

Health Conditions
  • Second and third degree haemorrhoids
Not Recruiting
Recruitment Status
ISRCTN41394716
Primary Trial ID Number
Summary
Haemorrhoidal artery ligation has a lower recurrence rate than rubber band ligation when used to treat second and third degree haemorrhoids. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/105746 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/81681/PRO-10-57-46.pdf
Primary Outcome Measures
  • Recurrence, defined as the proportion of patients with recurrent haemorrhoids at 12 months, as derived from a telephone assessment in combination with GP and hospital records. Patients who have undergone further treatment during the follow up period will be considered to have recurrent haemorrhoids.
  • Question to be asked:
  • 'At the moment, do you feel your symptoms from your haemorrhoids are:
  • 1. Cured or improved compared with before starting treatment; or,
  • 2. Unchanged or worse compared with before starting treatment?'
  • Any patient who answers '1' but has required further treatment since the initial procedure will be reclassified as '2', identified via hospital records, their consultant, their GP and patient questioning.
Secondary Outcome Measures
  • 1. Symptom score (before randomisation, 6 weeks, 1 year)
  • 2. Quality of Life, EQ-5D (before randomisation, 1, 7, 21 days, 6 weeks, 1 year)
  • 3. Continence questionnaire (before randomisation, 6 weeks, 1 year)
  • 4. Pain score [Visual Analogue Scale (VAS)], before randomisation, 1, 7, 21 days, 6 weeks)
  • 5. Health and social care resource use questionnaire (6 weeks, 1 year)
  • 6. Complications review (6 weeks, 1 year)
  • 7. Need for further treatment including details (6 weeks, 1 year)
  • 8. Clinical examination findings if recurrence (6 weeks)
Research Question
  • Haemorrhoidal artery ligation has a lower recurrence rate than rubber band ligation when used to treat second and third degree haemorrhoids. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/105746 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/81681/PRO-10-57-46.pdf
Design Type
Sorry, this information is not available
Ethics Approval
Approved by South Yorkshire REC, 13/06/2012, ref: 12/YH/0236
Publications
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23098097
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
350
Participant Inclusion Criteria
  • Current inclusion criteria as of 30/04/2013:
  • 1. Adults aged 18 years or over with symptomatic second or third degree haemorrhoids.
  • Previous inclusion criteria until 30/04/2013:
  • 1. Adults aged 18 years or over with symptomatic second or third degree haemorrhoids
  • 2. Either presenting for the first time or after failure of RBL
Participant Exclusion Criteria
  • Current exclusion criteria as of 30/04/2013:
  • 1. Patients that have had previous surgery for haemorrhoids (at any time)
  • 2. Patients that have had more than one injection treatment for haemorrhoids in the past 3 years
  • 3. Patients that have had more than one RBL procedure in the past 3 years
  • 4. Patients with known perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury
  • 5. Patients with an immunodeficiency
  • 6. Patients that are unable to have general or spinal anaesthetic
  • 7. Patients currently taking Warfarin Clopidogrel or have any other hypocoagulability condition
  • 8. Patients currently taking Nicorandil
  • 9. Pregnant women
  • 10. Patients that are unable to give full informed consent (this may be due to mental capacity or language barriers)
  • 11. Patients previously randomised to this trial
  • Previous exclusion criteria until 30/04/2013:
  • 1. Patients with known perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury
  • 2. Patients with an immunodeficiency
  • 3. Patients that are unable to have general or spinal anaesthetic
  • 4. Patients currently taking warfarin, or clopidogrel
  • 5. Patients currently taking Nicorandil
  • 6. Pregnant women
  • 7. Patients that are unable to give full informed consent (this may be due to mental capacity or language barriers)
  • 8. Patients previously randomised to this trial
Interventions
The intervention is either Rubber Band Ligation (RBL) or Haemorrhoidal Artery Ligation (HAL). Both interventions are established and well documented procedures. Conventional RBL uses a simple suction device that is applied to each haemorrhoid via a disposable proctoscope. A rubber band is then fired onto the base of the haemorrhoid which constricts the blood supply causing it to become ischaemic before being sloughed approximately 1-2 weeks later. The resultant fibrosis reduces any element of haemorrhoidal prolapse that may have been present. HAL uses a proctoscope modified to incorporate a Doppler transducer. This enables accurate detection of the haemorrhoidal arteries feeding the haemorrhoidal cushions. Accurate ligation of the vessels with a suture reduces haemorrhoidal engorgement. When combined with a 'pexy' suture, both bleeding and haemorrhoidal prolapse is addressed.
Design Details
Sorry, this information is not available
Study Design
Randomised controlled trial
Results Reporting
Sorry, this information is not available
Acronym
HubBLe
Scientific Title
A multi-centre randomised controlled trial comparing rubber band ligation with haemorrhoidal artery ligation in the management of symptomatic second and third degree haemorrhoids
Secondary Trial Identifying Number
HTA 10/57/46; Version 1.1, 12th June 2012
Website
Sorry, this information is not available
Study Funded By
NIHR - Health Technology Assessment Programme - HTA (UK) ref:10/57/46
Funder Type
Sorry, this information is not available
Study Sponsored By
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Oct 2012

Recruitment End Date

30 Sep 2013

Trial End Date

30 Sep 2014

Date added to Registry

10 May 2012

Last Updated

14 Jul 2015