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Pain Relief for Thrombosed External Haemorrhoids

This study has been completed.
Sponsor:
Information provided by:
University of Palermo
ClinicalTrials.gov Identifier:
NCT00717782
First received: July 16, 2008
Last updated: July 17, 2008
Last verified: July 2008
History of Changes
  Purpose

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 Intervention Phase
Thrombosed External Hemorrhoid
 Procedure: injection of botulinum toxin
Procedure: injection of saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Botulinum Toxin Injection for Pain Relief in Patients With Thrombosed External Haemorrhoids

Resource links provided by NLM:

MedlinePlus related topics: Botox Hemorrhoids
U.S. FDA Resources

Further study details as provided by University of Palermo:

Primary Outcome Measures:
  • evaluate the efficacy and safety of intrasphincteric injection of botulinum toxin for pain relief in patients with Thrombosed External Haemorrhoids. [ Time Frame: 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • evaluate the absence of side-effects and the simplicity of application [ Time Frame: 1 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2003
Study Completion Date: January 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: saline injection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717782

Sponsors and Collaborators
University of Palermo
Investigators
Principal Investigator: Gaetano Di Vita A.O.U.P.
Study Chair: Rosalia Patti A.O.U.P.
  More Information

No publications provided by University of Palermo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gaetano Di Vita, University of Palermo
ClinicalTrials.gov Identifier: NCT00717782     History of Changes
Other Study ID Numbers: UNIPA001
Study First Received: July 16, 2008
Last Updated: July 17, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by University of Palermo:
botulinum toxin
thrombosed external haemorrhoids
pain

Additional relevant MeSH terms:
Hemorrhoids
Thrombosis
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
 Cardiovascular Diseases
Embolism and Thrombosis
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013