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Unavailability of Triembutine maleate
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Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm.
A randomized trial will be carried out to investigate the effect of trimebutine on pain after Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which usually occurs after excisional hemorrhoidectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemorrhoidectomy | Sham Comparator | Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before |
|
| trimebutine | Active Comparator | Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimebutine | Drug | Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment assessed using visual analogue score from 0-10 | Anal pain will be assessed using visual analogue score from 0-10 | Pain will be assessed at 12 hours after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameh H Emile, M.D. | Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura university hospital | Al Mansurah | Dakahlia Governorate | Egypt |
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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 |
|---|---|
| D014287 | Trimebutine |
| D061865 | Hemorrhoidectomy |
| ID | Term |
|---|---|
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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|
| Hemorrhoidectomy | Procedure | Patients will undergo classic Milliagn-Morgan hemorrhoidectomy |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |