- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00841620
Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids
Symptom Control 1-year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Odense C, Denmark, 5000
- Odense University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Grades III and IV haemorrhoids
Exclusion Criteria:
- Previous operation for high anal fistula or injury to the anal sphincteres
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Haemorrhoidectomy a.m.
Milligan for grade 3-4 haemorrhoids
|
Surgery
|
Active Comparator: 2
Stapled anopexy for grade 3-4 haemorrhoids
|
Surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-reported frequency of symptoms
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Niels Qvist, Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STOPP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemorrhoids
-
Vilnius UniversityBiolitec Pharma Ltd.UnknownHemorrhoids Second Degree | Hemorrhoids Third DegreeLithuania
-
Ventrus Biosciences, IncTerminatedInternal HemorrhoidsUnited States
-
Societa Italiana di Chirurgia ColoRettaleSICCR - Gaetano GalloCompletedSecond-degree HemorrhoidsItaly
-
Medtronic - MITGCompletedHemorrhoids, InternalUnited States
-
The Second Affiliated Hospital of Hunan University...Hunan University of Traditional Chinese Medicine; Zhengfeng Medical Technology...Unknown
-
Universitätsklinikum Hamburg-EppendorfCompletedInternal Hemorrhoids
-
Nivagen Pharmaceuticals Inc.CompletedInternal HemorrhoidsUnited States, India
-
Universidade do PortoCompletedHemorrhoids, InternalPortugal
-
G & W Laboratories Inc.CompletedInternal HemorrhoidsUnited States
-
Kuwait Oil Company Ahmadi HospitalNetherlands: Ministry of Health, Welfare and SportsCompleted
Clinical Trials on Haemorrhoidectomy a.m. Milligan
-
Sengkang General HospitalBiolitecRecruitingHemorrhoidsSingapore
-
Holbaek SygehusRecruiting
-
The Second Affiliated Hospital of Hunan University...Hunan University of Traditional Chinese Medicine; Zhengfeng Medical Technology...Unknown
-
Northern Orthopaedic Division, DenmarkCompletedTotal Knee Arthritis | Viral; Infection, Slow VirusDenmark
-
Northern Lincolnshire and Goole Hospitals NHS Foundation...CompletedHaemorrhoids | Haemorrhoidectomy | Milligan-Morgan Haemorrhoidectomy | Open HaemorrhoidectomyUnited Kingdom
-
Assiut UniversityUnknownLigature; Hemorrhage
-
University of DundeeEthicon Endo-Surgery; Chief Scientist Office of the Scottish GovernmentCompleted
-
Universitätsklinikum Hamburg-EppendorfCompletedInternal Hemorrhoids
-
Vilnius UniversityBiolitec Pharma Ltd.UnknownHemorrhoids Second Degree | Hemorrhoids Third DegreeLithuania