Pain Relief for Thrombosed External Haemorrhoids

NCT00717782 | Completed Phase 4

• 1 other identifier: UNIPA001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Thrombosed External Hemorrhoid

Keywords

botulinum toxin; thrombosed external haemorrhoids; pain

Outcome Measures

Primary Outcomes (1)

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

  1

Secondary Outcomes (1)

• evaluate the absence of side-effects and the simplicity of application

  1

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

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

Also known as: botox injection

1

injection of saline PROCEDURE

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

Also known as: saline injection

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• thrombosed external haemorrhoids disease
• patients that refused surgery for fear of procedure related pain.

You may not qualify if:

• previous anal surgery
• third- and fourth-degree haemorrhoids
• anal fissure
• anal fistula
• presumed or confirmed pregnancy.

Sponsors & Collaborators

• University of Palermo: lead

Related Publications (1)

• 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.

  PMID: 18844269 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gaetano Di Vita

  A.O.U.P.

  PRINCIPAL INVESTIGATOR

• Rosalia Patti

  A.O.U.P.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: January 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: January 1, 2006
• Last Updated: July 18, 2008

Record last verified: 2008-07