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

This study has been completed.
Sponsor:
Collaborators:
Karolinska University Hospital
North Sealand Hospital, Helsinore, Denmark
Oxford University Hospitals NHS Trust
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00841620
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hemorrhoids
 Procedure: Haemorrhoidectomy a.m. Milligan (Diathermy)
Procedure: Stapled anopexy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Symptom Control 1-Year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-Trial

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Self-reported frequency of symptoms [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 207
Study Start Date: September 1999
Study Completion Date: April 2007
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Haemorrhoidectomy a.m. Milligan
 Procedure: Haemorrhoidectomy a.m. Milligan (Diathermy)
Surgery
Other Name: Diathermy
Active Comparator: 2
Stapled anopexy
 Procedure: Stapled anopexy
Surgery
Other Name: Circular stapler

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grades III and IV haemorrhoids

Exclusion Criteria:

  • Previous operation for high anal fistula or injury to the anal sphincteres
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841620

Locations
Denmark
Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Karolinska University Hospital
North Sealand Hospital, Helsinore, Denmark
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: Niels Qvist, Professor
  More Information

No publications provided

Responsible Party: Niels Qvist, professor, Surgical Department A, Odense University Hospital, DK-5000 Odense C, Denmark
ClinicalTrials.gov Identifier: NCT00841620     History of Changes
Other Study ID Numbers: STOPP
Study First Received: February 10, 2009
Last Updated: February 10, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Symptoms
Postoperative pain
Postoperative complications
Milligan
Anopxy

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013