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Completed

NCT Number: NCT00841620

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

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.

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Odense University Hospital

Odense C, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Grades III and IV haemorrhoids

Exclusion criteria

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

Treatment and study plan

Haemorrhoidectomy a.m. Milligan

Procedure

Surgery

Stapled anopexy

Procedure

Surgery

Primary outcomes

  1. Self-reported frequency of symptoms

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Karolinska University Hospital
  • Oxford University Hospitals NHS Trust

Registry information

Official study title

Symptom Control 1-year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-trial

Important dates

Study start
1999
Primary completion
2001
Study completion
2007
First posted
Feb 11, 2009
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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