Pain Relief for Thrombosed External Haemorrhoids

Sponsor

University of Palermo (Other)

Overall Status

Completed

CT.gov ID

NCT00717782

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Thrombosed External Hemorrhoid	Procedure: injection of botulinum toxin Procedure: injection of saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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.	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 Other Names: botox injection
Placebo Comparator: 2 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.	Procedure: injection of saline Patients received a 0·6-ml injection of a saline solution into the internal anal sphincter Other Names: saline injection

Arm

Intervention/Treatment

Experimental: 1

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.

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

Other Names:

botox injection

Placebo Comparator: 2

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.

Procedure: injection of saline

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

Other Names:

saline injection

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

evaluate the absence of side-effects and the simplicity of application [1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Palermo

Investigators

Principal Investigator: Gaetano Di Vita, A.O.U.P.
Study Chair: Rosalia Patti, A.O.U.P.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00717782

Other Study ID Numbers:

UNIPA001

First Posted:

Jul 18, 2008

Last Update Posted:

Jul 18, 2008

Last Verified:

Jul 1, 2008

Keywords provided by , ,

botulinum toxin

thrombosed external haemorrhoids

pain

Additional relevant MeSH terms:

Hemorrhoids

Thrombosis

Botulinum Toxins

Study Results

No Results Posted as of Jul 18, 2008