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

Odense University Hospital

Status and phase: Completed; Phase 4

Conditions: Hemorrhoids

Treatments: Procedure: Haemorrhoidectomy a.m. Milligan; Procedure: Stapled anopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT00841620

STOPP

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Grades III and IV haemorrhoids

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

1

Active Comparator group

Description:

Haemorrhoidectomy a.m. Milligan for grade 3-4 haemorrhoids

Treatment:

Procedure: Haemorrhoidectomy a.m. Milligan

2

Active Comparator group

Description:

Stapled anopexy for grade 3-4 haemorrhoids

Treatment:

Procedure: Stapled anopexy