Pain Relief for Thrombosed External Haemorrhoids - Full Text View

Sponsored by:	University of Palermo
Information provided by:	University of Palermo
ClinicalTrials.gov Identifier:	NCT00717782

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 IV

MedlinePlus related topics: Hemorrhoids

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Clinical Trial of Botulinum Toxin Injection for Pain Relief in Patients With Thrombosed External Haemorrhoids

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

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

Publications indexed to this study:

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.

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

Keywords provided by University of Palermo:

botulinum toxin
thrombosed external haemorrhoids
pain

Study placed in the following topic categories:

Embolism and Thrombosis
Botulinum Toxins
Digestive System Diseases
Embolism
Gastrointestinal Diseases
Vascular Diseases

Hemorrhoids
Pain
Botulinum Toxin Type A
Intestinal Diseases
Rectal Diseases
Thrombosis

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Therapeutic Uses
Cardiovascular Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009