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| Name | Class |
|---|---|
| Ethicon Endo-Surgery | INDUSTRY |
| Chief Scientist Office of the Scottish Government | OTHER_GOV |
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The aim of this study is to determine the role of stapled anopexy in the treatment of haemorrhoids by comparing it to the current gold standard treatment, which is excisional haemorrhoidectomy.
The current gold standard treatment of haemorrhoids namely, excisional haemorrhoidectomy is associated with severe postoperative pain and prolonged recovery period. Methods aiming at improving the outcome of excisional surgery included mainly modifications of the existing technique. Alternative instruments other than scissors have been used for the actual excision of haemorrhoids with a view to reducing the postoperative pain. However, with the wound in the sensitive anoderm following excisional haemorrhoidectomy, pain continues to be a major problem irrespective of the method of excision or of the instrument employed.
The new technique of stapled anopexy introduced in 1998 uses a radically different approach to treat haemorrhoids. The prolapsed anal cushion is repositioned and fixed without actually excising the haemorrhoidal pedicle thereby avoiding an external wound. This should result in reduction of the postoperative pain and subsequently should improve the recovery time. Further potential advantages of the technique should include a more physiological approach to the treatment of the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapled Anopexy | Experimental | Circular stapled anopexy |
|
| Conventional Haemorrhoidectomy | Active Comparator | Closed diathermy haemorrhoidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circular stapled anopexy | Procedure | Patients receiving stapled anopexy to treat haemorrhoids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | ||
| global haemorrhoidal symptom control | ||
| complication rates |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery | ||
| Time to return to work | ||
| Re-treatment rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert JC Steele, MD | University of Dundee | Principal Investigator |
| Mohamed A Thaha, MRCS | University of Dundee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ninewells Hospital & Medical School | Dundee | Scotland | DD1 9SY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15584064 | Result | Thaha MA, Irvine LA, Steele RJ, Campbell KL. Postdefaecation pain syndrome after circular stapled anopexy is abolished by oral nifedipine. Br J Surg. 2005 Feb;92(2):208-10. doi: 10.1002/bjs.4773. | |
| 19091821 | Result | Thaha MA, Campbell KL, Kazmi SA, Irvine LA, Khalil A, Binnie NR, Hendry WS, Walker A, Staines HJ, Steele RJ. Prospective randomised multi-centre trial comparing the clinical efficacy, safety and patient acceptability of circular stapled anopexy with closed diathermy haemorrhoidectomy. Gut. 2009 May;58(5):668-78. doi: 10.1136/gut.2008.151266. Epub 2008 Dec 17. |
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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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| Closed diathermy haemorrhoidectomy | Procedure | Conventional haemorrhoidectomy as described by Ferguson method |
|
| Day case surgeries |
| Quality of life changes |
| Patient satisfaction |
| Cost effectiveness |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |