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

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ClinicalTrials.gov Identifier: NCT00841620
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : May 4, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Procedure: Haemorrhoidectomy a.m. Milligan Procedure: Stapled anopexy Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 1999
Primary Completion Date : January 2001
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Haemorrhoidectomy a.m. Milligan for grade 3-4 haemorrhoids
Procedure: Haemorrhoidectomy a.m. Milligan
Active Comparator: 2
Stapled anopexy for grade 3-4 haemorrhoids
Procedure: Stapled anopexy

Outcome Measures

Primary Outcome Measures :
  1. Self-reported frequency of symptoms [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Grades III and IV haemorrhoids

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841620

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

Responsible Party: Niels Qvist, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00841620     History of Changes
Other Study ID Numbers: STOPP
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015

Keywords provided by Niels Qvist, Odense University Hospital:
Postoperative pain
Postoperative complications

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