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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00841620
First Posted: February 11, 2009
Last Update Posted: May 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Karolinska University Hospital
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
Niels Qvist, Odense University Hospital
  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 Procedure: Stapled anopexy Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Niels Qvist, Odense University Hospital:

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

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 for grade 3-4 haemorrhoids
Procedure: Haemorrhoidectomy a.m. Milligan
Surgery
Active Comparator: 2
Stapled anopexy for grade 3-4 haemorrhoids
Procedure: Stapled anopexy
Surgery

  Eligibility

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
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
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


Locations
Denmark
Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Karolinska University Hospital
Oxford University Hospitals NHS Trust
Investigators
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 Submitted: February 10, 2009
First Posted: February 11, 2009
Last Update Posted: May 4, 2015
Last Verified: April 2015

Keywords provided by Niels Qvist, 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