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Pain Relief for Thrombosed External Haemorrhoids

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00717782
Enrollment
30
Registered
2008-07-18
Start date
2003-01-31
Completion date
2006-01-31
Last updated
2008-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosed External Hemorrhoid

Keywords

botulinum toxin, thrombosed external haemorrhoids, pain

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.

Interventions

PROCEDUREinjection of botulinum toxin

Patients received a 0·6-ml injection of a solution containing 30 units botulinum toxin into the internal anal sphincter

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

Sponsors

University of Palermo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
evaluate the absence of side-effects and the simplicity of application1

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026