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NCT00927849 Clinical Trial

Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Hypertensive Anal Canal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00927849
Other study ID # hypertensive anal canal
Secondary ID
Status Completed
Phase N/A
First received March 23, 2009
Last updated May 7, 2009
Start date September 2002
Est. completion date May 2008

Study information
Verified date May 2009
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date May 2008
Est. primary completion date April 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 61 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Egypt Ayman Elnakeeb Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. Erratum in: N Engl J Med — View Citation

Neill ME, Swash M. Chronic perianal pain: an unsolved problem. J R Soc Med. 1982 Feb;75(2):96-101. — View Citation

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 Re — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal one year Yes
Primary Relieve of Anal Pain one year after the procedure Yes

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