Back to resultsTHD Versus Open Haemorrhoidectomy
Primary Purpose
Hemorrhoids
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transanal Haemorrhoidal Dearterialization
Open Haemorrhoidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids focused on measuring Hemorrhoids, Haemorrhoids, Transanal Haemorrhoidal Dearterialization, Transanal Hemorrhoidal Dearterialisation, Open Haemorrhoidectomy, Open Hemorrhoidectomy
Eligibility Criteria
Inclusion Criteria:
- The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
- 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 haemorrhoids within the last 2 years
- 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
Sites / Locations
- Departement of Surgery, Holbaek County Hospital.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transanal Haemorrhoidal Dearterialization
Open Haemorrhoidectomy
Arm Description
Patients randomised to Transanal Haemorrhoidal Dearterialization.
Patients randomised to Open Haemorrhoidectomy
Outcomes
Primary Outcome Measures
Haemorrhoidal Symptoms
Five questions regarding haemorrhoidal symptoms (pain, bleeding, itching, soiling and prolapse) are used to grade the symptom load. Each symptom is graded from 0-4, giving a total score from 0-20.
The symptom score is registered preoperatively, 3 and 12 months and 5 years postoperatively.
Secondary Outcome Measures
Postoperative pain
Postoperative pain is registered using visual analog scale (VAS), by the hospital staff in the immediate postoperative course during hospital stay and by the patient the first 14 days postoperatively.
Complications
Early and late complications are registered at 3 and 12 months and 5 years follow up.
Anal continence
Effect on anal continence is evaluated by Wexner Anal Incontinence Score and Revised Faecal Incotinence Score (RFIS) preoperatively, 3- and 12 months and 5 years postoperatively.
Quality of Life
QoL is evaluated using Short Health Scale, Short Form(SF)-36 and EQ-5D preoperatively, 1-year and 5-years postoperatively.
Health cost analysis
Health cost analysis will be based on an estimate of the cost of the operations, recovery of the patients and effect (need for further procedures or medical care).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02061176
Brief Title
THD Versus Open Haemorrhoidectomy
Official Title
Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holbaek Sygehus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively.
Secondary endpoints are postoperative pain, complications, effect on anal continence, recovery and return to normal activity, quality of life and health cost analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
Hemorrhoids, Haemorrhoids, Transanal Haemorrhoidal Dearterialization, Transanal Hemorrhoidal Dearterialisation, Open Haemorrhoidectomy, Open Hemorrhoidectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transanal Haemorrhoidal Dearterialization
Arm Type
Experimental
Arm Description
Patients randomised to Transanal Haemorrhoidal Dearterialization.
Arm Title
Open Haemorrhoidectomy
Arm Type
Active Comparator
Arm Description
Patients randomised to Open Haemorrhoidectomy
Intervention Type
Procedure
Intervention Name(s)
Transanal Haemorrhoidal Dearterialization
Other Intervention Name(s)
Hemorrhoidal Artery Ligation
Intervention Type
Procedure
Intervention Name(s)
Open Haemorrhoidectomy
Other Intervention Name(s)
Milligan Morgan, Haemorrhoidectomy
Primary Outcome Measure Information:
Title
Haemorrhoidal Symptoms
Description
Five questions regarding haemorrhoidal symptoms (pain, bleeding, itching, soiling and prolapse) are used to grade the symptom load. Each symptom is graded from 0-4, giving a total score from 0-20.
The symptom score is registered preoperatively, 3 and 12 months and 5 years postoperatively.
Time Frame
1-year and 5-years postoperatively
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain is registered using visual analog scale (VAS), by the hospital staff in the immediate postoperative course during hospital stay and by the patient the first 14 days postoperatively.
Time Frame
14 days postoperatively
Title
Complications
Description
Early and late complications are registered at 3 and 12 months and 5 years follow up.
Time Frame
1-year and 5-years postoperatively
Title
Anal continence
Description
Effect on anal continence is evaluated by Wexner Anal Incontinence Score and Revised Faecal Incotinence Score (RFIS) preoperatively, 3- and 12 months and 5 years postoperatively.
Time Frame
1-year and 5-years postoperatively
Title
Quality of Life
Description
QoL is evaluated using Short Health Scale, Short Form(SF)-36 and EQ-5D preoperatively, 1-year and 5-years postoperatively.
Time Frame
1-year and 5-years postoperatively
Title
Health cost analysis
Description
Health cost analysis will be based on an estimate of the cost of the operations, recovery of the patients and effect (need for further procedures or medical care).
Time Frame
1-year and 5-years postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
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 haemorrhoids within the last 2 years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Olaison, MD, Ph.D
Organizational Affiliation
Departement of Surgery, Holbaek County Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Surgery, Holbaek County Hospital.
City
Holbaek
ZIP/Postal Code
4300
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31996581
Citation
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.
Results Reference
derived
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THD Versus Open Haemorrhoidectomy
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