An interventional study of Transanal Haemorrhoidal Dearterialization and Open Haemorrhoidectomy in Hemorrhoids, sponsored by Holbaek Sygehus. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-12-04.
Sponsored by Holbaek Sygehus · Not applicable, Interventional, and Treatment
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.
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's planned enrollment of 90 is close to the median of 97 across 169 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Holbaek Sygehus is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomised to Transanal Haemorrhoidal Dearterialization.
Procedure: Transanal Haemorrhoidal Dearterialization
Patients randomised to Open Haemorrhoidectomy
Procedure: Open Haemorrhoidectomy
Also known as: Hemorrhoidal Artery Ligation
Also known as: Milligan Morgan, Haemorrhoidectomy
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.
Time frame: 1-year and 5-years postoperatively
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.
Time frame: 14 days postoperatively
Complications
Early and late complications are registered at 3 and 12 months and 5 years follow up.
Time frame: 1-year and 5-years postoperatively
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.
Time frame: 1-year 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.
Time frame: 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).
Time frame: 1-year and 5-years postoperatively
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Holbaek Sygehus