Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Mansoura University

Status: Completed

Conditions: Hypertensive Anal Canal

Treatments: Drug: botulinum toxin injection (BTX A); Procedure: lateral internal sphincterotomy (LIS); Drug: Glycerin trinitrate (GTN)

Study type: Interventional

Funder types: Other

Identifiers

NCT00927849

hypertensive anal canal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 61 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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63 participants in 3 patient groups

surgical group lateral sphincterotomy

Active Comparator group

Description:

underwent closed lateral internal sphincterotomy (LIS) under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.

Treatment:

Procedure: lateral internal sphincterotomy (LIS)

Glycerin trinitrate group

Active Comparator group

Description:

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.

Treatment:

Drug: Glycerin trinitrate (GTN)

botulinum toxin injection

Active Comparator group

Description:

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.

Treatment:

Drug: botulinum toxin injection (BTX A)