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Pain Relief for Thrombosed External Haemorrhoids

NCT ID: NCT00717782

Last Updated: 2008-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Thrombosed External Hemorrhoid

Keywords

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botulinum toxin thrombosed external haemorrhoids pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

injection of botulinum toxin

Intervention Type PROCEDURE

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

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.

Group Type PLACEBO_COMPARATOR

injection of saline

Intervention Type PROCEDURE

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

Interventions

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injection of botulinum toxin

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

Intervention Type PROCEDURE

injection of saline

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

Intervention Type PROCEDURE

Other Intervention Names

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botox injection saline injection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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University of Palermo

Principal Investigators

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Gaetano Di Vita

Role: PRINCIPAL_INVESTIGATOR

A.O.U.P.

Rosalia Patti

Role: STUDY_CHAIR

A.O.U.P.

References

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Patti R, Arcara M, Bonventre S, Sammartano S, Sparacello M, Vitello G, Di Vita G. Randomized clinical trial of botulinum toxin injection for pain relief in patients with thrombosed external haemorrhoids. Br J Surg. 2008 Nov;95(11):1339-43. doi: 10.1002/bjs.6236.

Reference Type DERIVED
PMID: 18844269 (View on PubMed)

Other Identifiers

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UNIPA001

Identifier Type: -

Identifier Source: org_study_id