Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

NCT ID: NCT00927849

Last Updated: 2009-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2008-05-31

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.

Conditions

Hypertensive Anal Canal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

lateral internal sphincterotomy (LIS)

Intervention Type: PROCEDURE

closed lateral internal sphincterotomy was done under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.

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.

Group Type: ACTIVE_COMPARATOR

Glycerin trinitrate (GTN)

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

botulinum toxin injection (BTX A)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

GTN ointment; BTX A

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mansoura University hospital

Principal Investigators

ayman elnakeeb, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Ayman Elnakeeb

Al Mansurah, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 14769323 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10395629 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15657647 (View on PubMed)

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

Reference Type: RESULT

PMID: 7069679 (View on PubMed)

Other Identifiers

hypertensive anal canal

Identifier Type: -

Identifier Source: org_study_id