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NCT00841620 Clinical Trial

Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids

Hemorrhoids Clinical Trial

Official title:
Symptom Control 1-year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00841620
Other study ID # STOPP
Secondary ID
Status Completed
Phase Phase 4
First received February 10, 2009
Last updated April 30, 2015
Start date September 1999
Est. completion date April 2007

Study information
Verified date April 2015
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 207
Est. completion date April 2007
Est. primary completion date January 2001
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Grades III and IV haemorrhoids

Exclusion Criteria:

- Previous operation for high anal fistula or injury to the anal sphincteres

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Haemorrhoidectomy a.m. Milligan
Surgery
• Stapled anopexy
Surgery

Locations
Country Name City State
Denmark Odense University Hospital Odense C

Sponsors (3)
Lead Sponsor Collaborator
Odense University Hospital Karolinska University Hospital, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Self-reported frequency of symptoms one year No
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