Pain Relief for Thrombosed External Haemorrhoids
|Thrombosed External Hemorrhoid||Procedure: injection of botulinum toxin Procedure: injection of saline||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Trial of Botulinum Toxin Injection for Pain Relief in Patients With Thrombosed External Haemorrhoids|
- 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 ]
|Study Start Date:||January 2003|
|Study Completion Date:||January 2006|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717782
|Principal Investigator:||Gaetano Di Vita||A.O.U.P.|
|Study Chair:||Rosalia Patti||A.O.U.P.|