ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Relief for Thrombosed External Haemorrhoids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00717782
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : July 18, 2008
Sponsor:
Information provided by:
University of Palermo

July 16, 2008
July 18, 2008
July 18, 2008
January 2003
December 2005   (Final data collection date for primary outcome measure)
evaluate the efficacy and safety of intrasphincteric injection of botulinum toxin for pain relief in patients with Thrombosed External Haemorrhoids. [ Time Frame: 1 ]
Same as current
No Changes Posted
evaluate the absence of side-effects and the simplicity of application [ Time Frame: 1 ]
Same as current
Not Provided
Not Provided
 
Pain Relief for Thrombosed External Haemorrhoids
Randomized Clinical Trial of Botulinum Toxin Injection for Pain Relief in Patients With Thrombosed External Haemorrhoids
Thrombosed external haemorrhoids are one of the most frequent anorectal emergencies. They are associated with swelling and intense pain. This study evaluated the efficacy and safety of an intersphincteric injection of botulinum toxin for pain relief in patients with thrombosed external haemorrhoids
Background: Thrombosed external haemorrhoids are one of the most frequent anorectal emergencies. They are associated with swelling and intense pain. Internal sphincter hypertonicity plays a role in the aetiology of the pain. This study evaluated the efficacy and safety of an intersphincteric injection of botulinum toxin for pain relief in patients with thrombosed external haemorrhoids. Methods: Thirty patients with thrombosed external haemorrhoids who refused surgical operation were randomized into two groups. Patients received an intrasphincteric injection of either 0·6 ml saline or 0·6 ml of a solution containing 30 units botulinum toxin. Anorectal manometry was performed before treatment and 5 days afterwards.Results: After 5 days of treatment, the maximum resting pressure fell in both groups, but was significantly lower in the botulinum toxin group (P = 0·004). Pain intensity was significantly reduced within 24 h of botulinum toxin treatment (P < 0·001), but only after 1 week in the placebo group (P = 0·019). Conclusion: A single injection of botulinum toxin into the anal sphincter seems to be effective in rapidly controlling the pain associated with thrombosed external haemorrhoids, and could represent an effective conservative treatment for this •condition.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Thrombosed External Hemorrhoid
  • 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
  • Procedure: injection of saline
    Patients received a 0·6-ml injection of a saline solution into the internal anal sphincter
    Other Name: saline injection
  • Experimental: 1

    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.

    Intervention: Procedure: injection of botulinum toxin
  • 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.

    Intervention: Procedure: injection of saline
Patti R, Arcara M, Bonventre S, Sammartano S, Sparacello M, Vitello G, Di Vita G. Randomized clinical trial of botulinum toxin injection for pain relief in patients with thrombosed external haemorrhoids. Br J Surg. 2008 Nov;95(11):1339-43. doi: 10.1002/bjs.6236.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
January 2006
December 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • thrombosed external haemorrhoids disease
  • patients that refused surgery for fear of procedure related pain.

Exclusion Criteria :

  • previous anal surgery
  • third- and fourth-degree haemorrhoids
  • anal fissure
  • anal fistula
  • presumed or confirmed pregnancy.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00717782
UNIPA001
No
Not Provided
Not Provided
Gaetano Di Vita, University of Palermo
University of Palermo
Not Provided
Principal Investigator: Gaetano Di Vita A.O.U.P.
Study Chair: Rosalia Patti A.O.U.P.
University of Palermo
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP