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

Primary Purpose

Hemorrhoids

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Haemorrhoidectomy a.m. Milligan
Stapled anopexy
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring Symptoms, Postoperative pain, Postoperative complications, Milligan, Anopxy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Grades III and IV haemorrhoids

Exclusion Criteria:

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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

Stapled anopexy for grade 3-4 haemorrhoids

Outcomes

Primary Outcome Measures

Self-reported frequency of symptoms

Secondary Outcome Measures

Full Information

First Posted
February 10, 2009
Last Updated
April 30, 2015
Sponsor
Odense University Hospital
Collaborators
Karolinska University Hospital, Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00841620
Brief Title
Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids
Official Title
Symptom Control 1-year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Karolinska University Hospital, Oxford University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
Symptoms, Postoperative pain, Postoperative complications, Milligan, Anopxy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Haemorrhoidectomy a.m. Milligan for grade 3-4 haemorrhoids
Arm Title
2
Arm Type
Active Comparator
Arm Description
Stapled anopexy for grade 3-4 haemorrhoids
Intervention Type
Procedure
Intervention Name(s)
Haemorrhoidectomy a.m. Milligan
Intervention Description
Surgery
Intervention Type
Procedure
Intervention Name(s)
Stapled anopexy
Intervention Description
Surgery
Primary Outcome Measure Information:
Title
Self-reported frequency of symptoms
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Grades III and IV haemorrhoids Exclusion Criteria: Previous operation for high anal fistula or injury to the anal sphincteres
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Qvist, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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