THD Versus Open Haemorrhoidectomy
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.
|Hemorrhoids||Procedure: Transanal Haemorrhoidal Dearterialization Procedure: Open Haemorrhoidectomy|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.|
- Haemorrhoidal Symptoms [ Time Frame: 1-year 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 postoperatively.
- Postoperative pain [ Time Frame: 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 [ Time Frame: 1-year postoperatively ]Early and late complications are registered at 3 and 12 months follow up.
- Anal continence [ Time Frame: 1-year postoperatively ]Effect on anal continence is evaluated by Wexner Anal Incontinence Score and Revised Faecal Incotinence Score (RFIS) preoperatively, 3- and 12 months postoperatively.
- Quality of Life [ Time Frame: 1-year postoperatively ]QoL is evaluated using Short Form(SF)-36 and EQ-5D preoperatively and 1-year postoperatively.
- Health cost analysis [ Time Frame: 1-year 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).
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: Transanal Haemorrhoidal Dearterialization
Patients randomised to Transanal Haemorrhoidal Dearterialization.
Procedure: Transanal Haemorrhoidal Dearterialization
Other Name: Hemorrhoidal Artery Ligation
Active Comparator: Open Haemorrhoidectomy
Patients randomised to Open Haemorrhoidectomy
Procedure: Open Haemorrhoidectomy
Please refer to this study by its ClinicalTrials.gov identifier: NCT02061176
|Departement of Surgery, Holbaek County Hospital.|
|Holbaek, Denmark, 4300|
|Principal Investigator:||Gunnar Olaison, MD, Ph.D||Departement of Surgery, Holbaek County Hospital|