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Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00927849
First received: March 23, 2009
Last updated: May 7, 2009
Last verified: May 2009

March 23, 2009
May 7, 2009
September 2002
April 2008   (final data collection date for primary outcome measure)
  • Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Relieve of Anal Pain [ Time Frame: one year after the procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00927849 on ClinicalTrials.gov Archive Site
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Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy
Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Idiopathic hypertensive anal canal is a fact and already exists presented by anal pain aggravated by defecation. It can be managed safely by closed lateral sphincterotomy but chemical sphincterotomy had a minor role in its management.

Patient and methods: Sixty three patients complaining of anal pain without any anal pathology and 10 healthy volunteers were examined. All patients underwent clinical evaluation, neurological examination, anorectal manometry, and measurement of pudendal nerve terminal motor latency (PNTML). All patients with hypertensive anal canal were randomized into three groups. Group I (surgical group) underwent closed lateral sphincterotomy LS, group II using nitroglycerine ointment (GTN) and group III received injection of botulinum toxin in internal sphincter. Post procedures data were recorded at follow up period.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hypertensive Anal Canal
  • Procedure: lateral internal sphincterotomy (LIS)
    closed lateral internal sphincterotomy was done under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
    Other Name: lateral INTERNAL sphincterotomy (LIS)
  • Drug: Glycerin trinitrate (GTN)
    All were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
    Other Name: GTN ointment
  • Drug: botulinum toxin injection (BTX A)
    All were injected with botulinum toxin injection (BTX- A) in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
    Other Name: BTX A
  • Active Comparator: surgical group lateral sphincterotomy
    underwent closed lateral internal sphincterotomy (LIS) under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
    Intervention: Procedure: lateral internal sphincterotomy (LIS)
  • Active Comparator: Glycerin trinitrate group
    all were instructed to apply the Glycerin trinitrate group (GTN) ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
    Intervention: Drug: Glycerin trinitrate (GTN)
  • Active Comparator: botulinum toxin injection
    All were injected with botulinum toxin injection (BTX- A) in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
    Intervention: Drug: botulinum toxin injection (BTX A)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
May 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients with hypertensive anal canal

Exclusion Criteria:

  • patients who had any pathological anorectal lesions such as anal fissure, piles, rectal prolapse, intussusception, anismus, cancer, patients with normal anal pressure
  • patients who previously had anorectal surgery, chemical or surgical sphincterotomy, anal dilatation, IBD, venereal disease, neurological disorder or systemic gastrointestinal disease
Both
18 Years to 61 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT00927849
hypertensive anal canal
Yes
ayman el nakeeb, Mansoura University hospital
Mansoura University
Not Provided
Principal Investigator: ayman elnakeeb, MD mansoura university hospital
Mansoura University
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP