Pain Relief for Thrombosed External Haemorrhoids

Phase 4

Completed

• Conditions: Thrombosed External Hemorrhoid
• Interventions: Procedure: injection of botulinum toxin; Procedure: injection of saline

• Registration Number: NCT00717782
• Lead Sponsor: University of Palermo

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2005-12
• Study Completion: 2006-01
• Status Verified: 2008-07
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-17
• Last Update Submitted: 2008-07-17
• Study First Posted: 2008-07-18
• Last Update Posted: 2008-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	injection of botulinum toxin	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.
2	injection of saline	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.

Primary Outcome Measures

Name	Time	Method
evaluate the efficacy and safety of intrasphincteric injection of botulinum toxin for pain relief in patients with Thrombosed External Haemorrhoids.	1

Secondary Outcome Measures

Name	Time	Method
evaluate the absence of side-effects and the simplicity of application	1