Pain Relief for Thrombosed External Haemorrhoids
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|ClinicalTrials.gov Identifier: NCT00717782|
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : July 18, 2008
|Condition or disease||Intervention/treatment||Phase|
|Thrombosed External Hemorrhoid||Procedure: injection of botulinum toxin Procedure: injection of saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial of Botulinum Toxin Injection for Pain Relief in Patients With Thrombosed External Haemorrhoids|
|Study Start Date :||January 2003|
|Primary Completion Date :||December 2005|
|Study Completion Date :||January 2006|
Patients were injected with 0·6 ml of a solution containing 30 units botulinum toxin A (Botox; Allergan, Ireland).
A 27-G needle was used to give two injections of equal volume (0·3 ml) into the internal anal sphincter, one on each side of the anterior midline of the sphincter.
Procedure: injection of botulinum toxin
Patients received a 0·6-ml injection of a solution containing 30 units botulinum toxin into the internal anal sphincter
Other Name: botox injection
Placebo Comparator: 2
Patients in the placebo group received a 0·6-ml injection of saline.
A27-G needle was used to give two injections of equal volume (0·3 ml) into the internal anal sphincter, one on each side of the anterior midline of the sphincter.
Procedure: injection of saline
Patients received a 0·6-ml injection of a saline solution into the internal anal sphincter
Other Name: saline injection
- evaluate the efficacy and safety of intrasphincteric injection of botulinum toxin for pain relief in patients with Thrombosed External Haemorrhoids. [ Time Frame: 1 ]
- evaluate the absence of side-effects and the simplicity of application [ Time Frame: 1 ]
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): NCT00717782
|Principal Investigator:||Gaetano Di Vita||A.O.U.P.|
|Study Chair:||Rosalia Patti||A.O.U.P.|