Clinical trial NCT00717782: Pain Relief for Thrombosed External Haemorrhoids
Official title: Randomized Clinical Trial of Botulinum Toxin Injection for Pain Relief in Patients With Thrombosed External Haemorrhoids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thrombosed External Hemorrhoid
Keywords: botulinum toxin
thrombosed external haemorrhoids
pain
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2008-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: evaluate the efficacy and safety of intrasphincteric injection of botulinum toxin for pain relief in patients with Thrombosed External Haemorrhoids.
timeFrame: 1
Secondary outcomes:
measure: evaluate the absence of side-effects and the simplicity of application
timeFrame: 1
Other outcomes:
Locations:
Study officials:
affiliation: A.O.U.P.
name: Gaetano Di Vita
role: PRINCIPAL_INVESTIGATOR
affiliation: A.O.U.P.
name: Rosalia Patti
role: STUDY_CHAIR
References:
citation: 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.