Official Title

Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy
  • Phase

    N/A
  • Study Type

    Interventional
  • Intervention/Treatment

    glycerin rimabotulinumtoxinB ...
  • Study Participants

    63
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.
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.
Study Started
Sep 30
2002
Primary Completion
Apr 30
2008
Study Completion
May 31
2008
Results Posted
Jun 25
2009
Estimate
Last Update
Jun 25
2009
Estimate

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.

  • Other names: GTN ointment

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.

  • Other names: BTX A

surgical group lateral sphincterotomy Active Comparator

underwent closed lateral internal sphincterotomy (LIS) under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.

Glycerin trinitrate group Active Comparator

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.

botulinum toxin injection Active Comparator

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.

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

Summary

Surgical Group Lateral Sphincterotomy

Glycein Trinitrate Group

Botilinium Toxin Injection

All Events

Event Type Organ System Event Term

Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal

effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery

Outcome Measure Data Not Reported

Relieve of Anal Pain

using a visual analog scale (VAS) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 ( severe pain)

Surgical Group Lateral Sphincterotomy

4.16
score in scale (Mean)
Standard Deviation: 2.32

Glycein Trinitrate Group

4.18
score in scale (Mean)
Standard Deviation: 2.52

Botilinium Toxin Injection

4.2
score in scale (Mean)
Standard Deviation: 2.42

Total

63
Participants

Age Continuous

41
years (Mean)
Standard Deviation: 6.5

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Surgical Group Lateral Sphincterotomy

Glycein Trinitrate Group

Botilinium Toxin Injection