Haemorrhoid surgery Surgery
Conditions
Interventions
Potential patients will be referred to a NHS recruiting centre for the treatment of grade II/III haemorrhoids.
Potential patients will fall into two groups:
1. Patients that present to the surgical o
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/07/2022: 1. Adults aged 18 years or over with symptomatic grade II or grade III haemorrhoids 2. And patients who have failed conservative management for haemorrhoids (diet and lifestyle changes) and want further intervention 3. And/or patients who have failed either one episode of Rubber Band Ligation (RBL) or have grade III haemorrhoids considered inappropriate for RBL treatment and/or have grade II or III haemorrhoids which the surgeon feels operative intervention is appropriate Previous inclusion criteria: 1. Adults aged 18 years or over with symptomatic grade II or grade III haemorrhoids 2. And patients who have failed conservative management for haemorrhoids (diet and lifestyle changes) and want further intervention 3. And patients who have failed either one episode of Rubber Band Ligation (RBL) or have grade III haemorrhoids considered inappropriate for RBL treatment
Exclusion criteria
Exclusion criteria: 1. Patients with known perianal sepsis, inflammatory bowel disease, anal or colorectal malignancy, pre-existing sphincter injury 2. Patients with an immunodeficiency (HIV or other medical issue) 3. Patients who are unable to have general or spinal anaesthetic 4. Patients currently taking Warfarin, Clopidogrel or any other hypercoagulability condition 5. Pregnant women 6. Patients with a pacemaker 6. Patients unable to give full informed consent 7. Patients previously randomised to this trial 8. Patients participating in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recurrence at 12 months post procedure measured using patient records 2. Pain measured by Numeric Pain Rating Scale (NPRS) daily over 7 days post procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain is measured by the 'Numeric Pain Rating Scale' at baseline (day of surgery), 1 day, 7 days, 21 days 6 week and 1 year post procedure 2. Incontinence score is measured by Vaizey incontinence score baseline (day of surgery), 6 weeks post surgery, 1 year post surgery 3. Quality of life measured by EQ5D: baseline (day of surgery), 1 day, 7 days, 21 days 6 week and 1 year post procedure 4. Severity of haemorrhoid measured by haemorrhoid severity score baseline (day of surgery), 6 weeks post surgery, 1 year post surgery 5. Operation details: day of surgery 6. Recurrence of symptoms measured by complications review interview; 6 weeks post surgery, 1 year post surgery 7. Economic impact: days of work lost questionnaire: 6 weeks post surgery, 1 year post surgery 8. Recurrence of hemorrhoid measured by a triangulation of participant question based on Hubble Trial, surgeons questionnaire and GP questionnaire; week 6 post surgery and 1 year post surgery 9. Haemorrhoid severity measured by clinical appearance at proctoscopy: 6 weeks post surgery | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactCarla;Study Girling;Team
;
Outcome results
None listed