The eTHoS study (haemorrhoids treatment): either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for haemorrhoidal disease

Completed

• Conditions: Haemorrhoidal disease; Circulatory System; Haemorrhoids

• Registration Number: ISRCTN80061723
• Lead Sponsor: Co-sponsored by University of Aberdeen (UK) and NHS Highland

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25388563 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27726951 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29205150

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-08
• Study Completion: 2016-09-30
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 800

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

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 sphincter 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The trial has both a patient-centred and an economic primary outcome:<br>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)<br>2. Economic: incremental cost per quality adjusted life year (QALY) gained with QALYs based on the responses to the EQ-5D at 24 months