CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Glycerin trinitrate (GTN) +2 moredrug
Likely dose
botulinum toxin injection (BTX A) 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00927849
NCT00927849N/ACompleted

Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Mansoura University·interventional·Posted Jun 25, 2009·Updated Jun 25, 2009

In Brief

A clinical study evaluating lateral internal sphincterotomy (LIS), Glycerin trinitrate (GTN), and 1 other intervention for Hypertensive Anal Canal. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2009
Enrollment StartSep 1, 2002
Primary CompletionApr 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 17.0 years ago

Interventions

lateral internal sphincterotomy (LIS)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 (GTN)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 (BTX A)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.