Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2013-10-31
2021-12-31
Brief Summary
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Secondary endpoints are postoperative pain, complications, effect on anal continence, recovery and return to normal activity, quality of life and health cost analysis.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transanal Haemorrhoidal Dearterialization
Patients randomised to Transanal Haemorrhoidal Dearterialization.
Transanal Haemorrhoidal Dearterialization
Open Haemorrhoidectomy
Patients randomised to Open Haemorrhoidectomy
Open Haemorrhoidectomy
Interventions
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Transanal Haemorrhoidal Dearterialization
Open Haemorrhoidectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient has a Haemorrhoidal Symptom Score of 4 or more
* The patient has an American Society of Anaesthesiologists (ASA) score I-II
* The patient's age is 18-85 years at inclusion
* The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion
Exclusion Criteria
* The patient has had previous operation for anal incontinence
* The patient has an active anal fistula
* The patient has an active anal fissure
* The patient has anal incontinence for solid stools
18 Years
85 Years
ALL
No
Sponsors
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Holbaek Sygehus
OTHER
Responsible Party
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Per Olov Gunnar Olaison
MD, PhD
Principal Investigators
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Gunnar Olaison, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Departement of Surgery, Holbaek County Hospital
Locations
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Departement of Surgery, Holbaek County Hospital.
Holbæk, , Denmark
Countries
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References
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Rorvik HD, Campos AH, Styr K, Ilum L, McKinstry GK, Brandstrup B, Olaison G. Minimal Open Hemorrhoidectomy Versus Transanal Hemorrhoidal Dearterialization: The Effect on Symptoms: An Open-Label Randomized Controlled Trial. Dis Colon Rectum. 2020 May;63(5):655-667. doi: 10.1097/DCR.0000000000001588.
Other Identifiers
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Holbaek Haemorrhoid Study
Identifier Type: -
Identifier Source: org_study_id