Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2008

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.

Interventions

  • 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.
  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal
    • Time Frame: one year
    • effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery
  • Relieve of Anal Pain
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 61 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • ayman el nakeeb, Mansoura University hospital
  • Overall Official(s)
    • ayman elnakeeb, MD, Principal Investigator, Mansoura University Hospital

Citations Reporting on Results

Aysan E, Aren A, Ayar E. A prospective, randomized, controlled trial of primary wound closure after lateral internal sphincterotomy. Am J Surg. 2004 Feb;187(2):291-4. doi: 10.1016/j.amjsurg.2003.11.011.

Brisinda G, Maria G, Bentivoglio AR, Cassetta E, Gui D, Albanese A. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med. 1999 Jul 8;341(2):65-9. doi: 10.1056/NEJM199907083410201. Erratum In: N Engl J Med 1999 Aug 19;341(8):624.

Orsay C, Rakinic J, Perry WB, Hyman N, Buie D, Cataldo P, Newstead G, Dunn G, Rafferty J, Ellis CN, Shellito P, Gregorcyk S, Ternent C, Kilkenny J 3rd, Tjandra J, Ko C, Whiteford M, Nelson R; Standards Practice Task Force; American Society of Colon and Rectal Surgeons. Practice parameters for the management of anal fissures (revised). Dis Colon Rectum. 2004 Dec;47(12):2003-7. doi: 10.1007/s10350-004-0785-7. No abstract available.

Neill ME, Swash M. Chronic perianal pain: an unsolved problem. J R Soc Med. 1982 Feb;75(2):96-101. doi: 10.1177/014107688207500205.

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