The eTHoS STUDY (haemorrhoids treatment): either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for haemorrhoidal disease | Not Recruiting
The eTHoS STUDY (haemorrhoids treatment): either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for haemorrhoidal disease
eTHoS
Trial Source

Health Conditions
  • Haemorrhoidal disease
Not Recruiting
Recruitment Status
ISRCTN80061723
Primary Trial ID Number
Summary
The study is investigating whether stapled haemorrhoidopexy (surgical) treatment improves clinical effectiveness and cost-effectiveness compared with traditional excisional haemorrhoidectomy. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/082402 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/52878/PRO-08-24-02.pdf As of 08/03/2010, the anticipated start date of this trial was changed from 01/04/2010 to 01/10/2010. As of 01/02/2011, the anticipated end date of this trial was changed from 31/03/2015 to 30/09/2015. As of 01/05/2013, the anticipated end date of this trial was changed from 30/09/2015 to 30/09/2016. As of 11/09/2013, the public title was changed from "The eTHoS STUDY: either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for haemorrhoidal disease" to "The eTHoS STUDY (haemorrhoids treatment): either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for haemorrhoidal disease".
Primary Outcome Measures
  • The trial has both a patient-centred and an economic primary outcome:
  • 1. Patient-centred: quality of life profile (area under the curve derived from EQ-5D measurements at baseline, 1 week, 3 weeks, 6 weeks, 12 months and 24 months)
  • 2. Economic: incremental cost per quality adjusted life year (QALY) gained with QALYs based on the responses to the EQ-5D at 24 months
Secondary Outcome Measures
  • Secondary outcomes include patient-reported, clinical and economic measures:
  • Patient-reported (collected at 1, 3, 6 weeks, 1 year, 2 years and 5 years):
  • 1. Generic health profile measured by 36-item short form health survey (SF-36) and EQ-5D
  • 2. Visual analogue scale (VAS) pain score
  • 3. Cleveland incontinence score
  • 4. Haemorrhoid symptom score
  • 5. Post-operative analgesia consumption
  • 6. Recurrence of haemorrhoids
  • Clinical (collected at the time of surgery and at 6-week clinical follow-up):
  • 7. Peri- and post-operative complications including:
  • 7.1. Haemorrhages
  • 7.2. Requirement for blood transfusion
  • 7.3. Anal stenosis, anal fissure
  • 7.4. Urinary retention
  • 7.5. Residual anal skin tags
  • 7.6. Difficult defecation
  • 7.7. Wound discharge
  • 7.8. Pelvic sepsis
  • 7.9. Pruritis
  • Economic:
  • Costs will be based on resource use data.
  • 8. Costs to the NHS and patients at two years:
  • 8.1. Time to recovery
  • 8.2. Length of hospital stay
  • 8.3. Use of health services for haemorrhoids related events or treatments
  • 8.4. Patient costs (treatments], travel to health services, sick leave)
  • 8.5. Need for alternative management for haemorrhoids (e.g., surgery, drugs)
  • 8.6. Other use of health services:
  • 8.6.1. Visits to GP
  • 8.6.2. Visits to practice nurse
  • 8.6.3. Visits to colorectal surgeon
  • 9. Estimated lifetime cost to NHS and patient
  • 10. QALYS estimated from the EQ-5D at 24 months
  • 11. QALYS estimated over the patient's lifetime
  • 12. Cost-effectiveness analysis (incremental cost per case of stapled haemorrhoidopexy and traditional haemorrhoidectomy excision avoided)
Research Question
  • The study is investigating whether stapled haemorrhoidopexy (surgical) treatment improves clinical effectiveness and cost-effectiveness compared with traditional excisional haemorrhoidectomy. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/082402 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/52878/PRO-08-24-02.pdf As of 08/03/2010, the anticipated start date of this trial was changed from 01/04/2010 to 01/10/2010. As of 01/02/2011, the anticipated end date of this trial was changed from 31/03/2015 to 30/09/2015. As of 01/05/2013, the anticipated end date of this trial was changed from 30/09/2015 to 30/09/2016. As of 11/09/2013, the public title was changed from "The eTHoS STUDY: either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for haemorrhoidal disease" to "The eTHoS STUDY (haemorrhoids treatment): either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for haemorrhoidal disease".
Design Type
Sorry, this information is not available
Ethics Approval
North of Scotland Research Ethics Service granted full approval on 17/06/2010
Publications
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25388563
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
800
Participant Inclusion Criteria
  • Current inclusion criteria as of 02/01/2011:
  • 1. Patient with circumferential haemorrhoids grade II, III and IV.
  • 2. Patients aged 18 years or older.
  • 3. Written informed consent obtained.
  • Previous inclusion criteria:
  • 1. Patients with haemorrhoids grade II who have failed traditional therapy (rubber band ligation [RBL]), haemorrhoids grade III and IV
  • 2. Patients aged 18 years or older, either sex
  • 3. Written informed consent obtained
Participant Exclusion Criteria
  • Current exclusion criteria as of 01/02/2011:
  • 1. Previous surgery for haemorrhoids (traditional or stapled) (except rubber band ligation (RBL) or Haemorrhoidal Artery Ligation Operation (HALO)).
  • 2. Pre-existing spincter injury.
  • 3. Peri-anal sepsis.
  • 4. Inflammatory bowel disease.
  • 5. Malignant colorectal disease.
  • 6. Medically unfit for surgery or completion of the trial.
  • 7. Pregnant women.
  • Previous exclusion criteria:
  • 1. Previous surgery for haemorrhoids (except RBL for grade II)
Interventions
Participants will be randomised to either stapled haemorrhoidopexy (SH) or traditional haemorrhoidectomy (TH). The SH procedure involves excising a ring or "donut" of tissue above the haemorrhoidal cushions with immediate re-anastomosis of the mucosa using staples. TH involves excision of the haemorrhoidal cushions. Patients will be followed-up in clinic approximately six weeks after their surgery. Postal questionnaires will be completed by participants at 1, 3 and 6 weeks after surgery and 1 and 2 years after randomisation. It is also the intention to follow-up participants in the longer-term through a 5-year postal questionnaire.
Design Details
Sorry, this information is not available
Study Design
Multicentre randomised controlled trial
Results Reporting
Sorry, this information is not available
Acronym
eTHoS
Scientific Title
A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease
Secondary Trial Identifying Number
HTA 08/24/02
Website
http://www.charttrials.abdn.ac.uk/ethos/
Study Funded By
NIHR Health Technology Assessment Programme - HTA (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
Co-sponsored by University of Aberdeen (UK) and NHS Highland
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 2010

Recruitment End Date

31 Aug 2014

Trial End Date

30 Sep 2016

Date added to Registry

08 Mar 2010

Last Updated

13 Apr 2015