Pain Relief for Thrombosed External Haemorrhoids
Primary Purpose
Thrombosed External Hemorrhoid
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
injection of botulinum toxin
injection of saline
Sponsored by
About this trial
This is an interventional treatment trial for Thrombosed External Hemorrhoid focused on measuring botulinum toxin, thrombosed external haemorrhoids, pain
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
evaluate the efficacy and safety of intrasphincteric injection of botulinum toxin for pain relief in patients with Thrombosed External Haemorrhoids.
Secondary Outcome Measures
evaluate the absence of side-effects and the simplicity of application
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00717782
Brief Title
Pain Relief for Thrombosed External Haemorrhoids
Official Title
Randomized Clinical Trial of Botulinum Toxin Injection for Pain Relief in Patients With Thrombosed External Haemorrhoids
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Palermo
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosed External Hemorrhoid
Keywords
botulinum toxin, thrombosed external haemorrhoids, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
injection of botulinum toxin
Other Intervention Name(s)
botox injection
Intervention Description
Patients received a 0·6-ml injection of a solution containing 30 units botulinum toxin into the internal anal sphincter
Intervention Type
Procedure
Intervention Name(s)
injection of saline
Other Intervention Name(s)
saline injection
Intervention Description
Patients received a 0·6-ml injection of a saline solution into the internal anal sphincter
Primary Outcome Measure Information:
Title
evaluate the efficacy and safety of intrasphincteric injection of botulinum toxin for pain relief in patients with Thrombosed External Haemorrhoids.
Time Frame
1
Secondary Outcome Measure Information:
Title
evaluate the absence of side-effects and the simplicity of application
Time Frame
1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Di Vita
Organizational Affiliation
A.O.U.P.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosalia Patti
Organizational Affiliation
A.O.U.P.
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
18844269
Citation
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.
Results Reference
derived
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Pain Relief for Thrombosed External Haemorrhoids
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