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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
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosed External Hemorrhoid focused on measuring botulinum toxin, thrombosed external haemorrhoids, pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 16, 2008
    Last Updated
    July 17, 2008
    Sponsor
    University of Palermo
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    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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