Hemorrhoids
Conditions
Keywords
Hemorrhoids, Haemorrhoids, Transanal Haemorrhoidal Dearterialization, Transanal Hemorrhoidal Dearterialisation, Open Haemorrhoidectomy, Open Hemorrhoidectomy
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.
Interventions
PROCEDURETransanal Haemorrhoidal Dearterialization
PROCEDUREOpen Haemorrhoidectomy
Sponsors
Holbaek Sygehus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemorrhoidal Symptoms | 1-year and 5-years postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Anal continence | 1-year and 5-years postoperatively | 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 | 1-year and 5-years postoperatively | QoL is evaluated using Short Health Scale, Short Form(SF)-36 and EQ-5D preoperatively, 1-year and 5-years postoperatively. |
| Postoperative pain | 14 days postoperatively | 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 | 1-year and 5-years postoperatively | Early and late complications are registered at 3 and 12 months and 5 years follow up. |
| Health cost analysis | 1-year and 5-years postoperatively | 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). |
Countries
Denmark
Outcome results
None listed