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
  Purpose

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.


Condition Intervention
Hypertensive Anal Canal
Procedure: lateral internal sphincterotomy (LIS)
Drug: Glycerin trinitrate (GTN)
Drug: botulinum toxin injection (BTX A)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 63
Study Start Date: September 2002
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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.
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
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00927849

Locations
Egypt
Ayman Elnakeeb
Mansoura, Egypt, 335111
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: ayman elnakeeb, MD mansoura university hospital
  More Information

Publications:
Responsible Party: ayman el nakeeb, Mansoura University hospital
ClinicalTrials.gov Identifier: NCT00927849     History of Changes
Other Study ID Numbers: hypertensive anal canal
Study First Received: March 23, 2009
Results First Received: March 23, 2009
Last Updated: May 7, 2009
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
anal hypertonia
sphincterotomy
incontinence
manometry

Additional relevant MeSH terms:
Botulinum Toxins
Glycerol
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014