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

Phase 4

Completed

• Conditions: Hemorrhoids
• Interventions: Procedure: Stapled anopexy; Procedure: Haemorrhoidectomy a.m. Milligan

• Registration Number: NCT00841620
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2001-01
• Study Completion: 2007-04
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• Grades III and IV haemorrhoids

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Stapled anopexy	Stapled anopexy for grade 3-4 haemorrhoids
1	Haemorrhoidectomy a.m. Milligan	Haemorrhoidectomy a.m. Milligan for grade 3-4 haemorrhoids

Primary Outcome Measures

Name	Time	Method
Self-reported frequency of symptoms	one year

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense C, Denmark