Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Conditions
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Hypertensive Anal Canal

Intervention / Treatment
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* Procedure: lateral internal sphincterotomy (LIS)
* Drug: Glycerin trinitrate (GTN)
* Drug: botulinum toxin injection (BTX A)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 61 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgical group lateral sphincterotomy<br>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)<br>* closed lateral internal sphincterotomy was done under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.<br>|
| Active Comparator: Glycerin trinitrate group<br>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)<br>* 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.<br>* Other names: GTN ointment;|
| Active Comparator: botulinum toxin injection<br>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)<br>* 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.<br>* Other names: BTX A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal | effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery | one year | 
| Relieve of Anal Pain | using a visual analog scale (VAS) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 ( severe pain) | one year after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal hypertonia, sphincterotomy, incontinence, manometry