Pain Relief for Thrombosed External Haemorrhoids

Thrombosed External Hemorrhoid Clinical Trial

Official title:

Randomized Clinical Trial of Botulinum Toxin Injection for Pain Relief in Patients With Thrombosed External Haemorrhoids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717782
• Other study ID #: UNIPA001
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2008
• Last updated: July 17, 2008
• Start date: January 2003
• Est. completion date: January 2006

Study information

• Verified date: July 2008
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• Thrombosed External Hemorrhoid
• Thrombosis

Intervention

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
• injection of saline
Patients received a 0·6-ml injection of a saline solution into the internal anal sphincter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the efficacy and safety of intrasphincteric injection of botulinum toxin for pain relief in patients with Thrombosed External Haemorrhoids.		1	Yes
Secondary	evaluate the absence of side-effects and the simplicity of application		1	Yes