THD Versus Open Haemorrhoidectomy
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|ClinicalTrials.gov Identifier: NCT02061176|
Recruitment Status : Unknown
Verified December 2017 by Per Olov Gunnar Olaison, Holbaek Sygehus.
Recruitment status was: Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : December 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Procedure: Transanal Haemorrhoidal Dearterialization Procedure: Open Haemorrhoidectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.|
|Actual Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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
- Haemorrhoidal Symptoms [ Time Frame: 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.
- 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 and 5-years postoperatively ]Early and late complications are registered at 3 and 12 months and 5 years follow up.
- Anal continence [ Time Frame: 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 [ Time Frame: 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.
- Health cost analysis [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061176
|Departement of Surgery, Holbaek County Hospital.|
|Holbaek, Denmark, 4300|
|Principal Investigator:||Gunnar Olaison, MD, Ph.D||Departement of Surgery, Holbaek County Hospital|