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Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

NCT00927849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2009-06-25

Study results available
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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.

Conditions

  • Hypertensive Anal Canal

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • ayman elnakeeb, MD · Mansoura University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2008-04-30
Completion
2008-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00927849 on ClinicalTrials.gov