Pain Relief for Thrombosed External Haemorrhoids
|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 ]
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.|