Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids
NCT00841620 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 207
Last updated 2015-05-04
Summary
Background: In an international randomised controlled trial we studied how patient self-reported symptoms improved after either a stapled anopexy operation or a diathermy excision of the haemorrhoids.
Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Two hundred and seven patients were randomised. After exclusion of 27 patients, 90 in both groups were operated and followed one year. Patients provided self-reported symptoms before surgery and after 1 year. A patient diary obtained daily self-reported postoperative pain scores (VAS). Surgeons evaluated the anal anatomy before surgery and after 1 year.
Conditions
Interventions
- PROCEDURE
-
Haemorrhoidectomy a.m. Milligan
Surgery
- PROCEDURE
-
Stapled anopexy
Surgery
Sponsors & Collaborators
-
Karolinska University Hospital
collaborator OTHER -
Oxford University Hospitals NHS Trust
collaborator OTHER -
Odense University Hospital
lead OTHER
Principal Investigators
-
Niels Qvist, Professor
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-09-30
- Primary Completion
- 2001-01-31
- Completion
- 2007-04-30
Countries
- Denmark
Study Locations
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