Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Not Applicable

Completed

• Conditions: Hypertensive Anal Canal
• Interventions: Drug: Glycerin trinitrate (GTN); Procedure: lateral internal sphincterotomy (LIS); Drug: botulinum toxin injection (BTX A)

• Registration Number: NCT00927849
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2008-04
• Study Completion: 2008-05
• Study First Submitted: 2009-03-23
• Results First Submitted: 2009-03-23
• Status Verified: 2009-05
• Study First Submitted QC: 2009-05-07
• Results First Submitted QC: 2009-05-07
• Last Update Submitted: 2009-05-07
• Study First Posted: 2009-06-25
• Results First Posted: 2009-06-25
• Last Update Posted: 2009-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glycerin trinitrate group	Glycerin trinitrate (GTN)	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.
surgical group lateral sphincterotomy	lateral internal sphincterotomy (LIS)	underwent closed lateral internal sphincterotomy (LIS) under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
botulinum toxin injection	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.

Primary Outcome Measures

Name	Time	Method
Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal	one year	effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery
Relieve of Anal Pain	one year after the procedure	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)

Trial Locations

Locations (1)

Ayman Elnakeeb; 🇪🇬 Mansoura, Egypt