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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transanal Haemorrhoidal Dearterialization | Experimental | Patients randomised to Transanal Haemorrhoidal Dearterialization. |
|
| Open Haemorrhoidectomy | Active Comparator | Patients randomised to Open Haemorrhoidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal Haemorrhoidal Dearterialization | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-year and 5-years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days postoperatively |
| Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Olaison, MD, Ph.D | Departement of Surgery, Holbaek County Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Surgery, Holbaek County Hospital. | Holbæk | 4300 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31996581 | Derived | 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. |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D061865 | Hemorrhoidectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Open Haemorrhoidectomy | Procedure |
|
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Early and late complications are registered at 3 and 12 months and 5 years follow up. |
| 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. | 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. | 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). | 1-year and 5-years postoperatively |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |