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Completed

NCT Number: NCT00717782

Pain Relief for 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

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Key information

Conditions

Thrombosed External Hemorrhoid Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

injection of botulinum toxin

Procedure

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

Other names: botox injection

Injection of saline

Procedure

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

Other names: saline injection

Primary outcomes

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

    Time frame: 1

Secondary outcomes

  1. evaluate the absence of side-effects and the simplicity of application

    Time frame: 1

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2006
First posted
Jul 18, 2008
Registry last updated
Jul 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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