Clinical trial NCT00927849: Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy
Official title: Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertensive Anal Canal
Keywords: anal hypertonia
sphincterotomy
incontinence
manometry
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal
timeFrame: one year
measure: Relieve of Anal Pain
timeFrame: one year after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ayman Elnakeeb
Study officials:
affiliation: Mansoura University Hospital
name: ayman elnakeeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1056/NEJM199907083410201.
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 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.
citation: Neill ME, Swash M. Chronic perianal pain: an unsolved problem. J R Soc Med. 1982 Feb;75(2):96-101. doi: 10.1177/014107688207500205.