Hypertensive Anal Canal
Conditions
Keywords
anal hypertonia, sphincterotomy, incontinence, manometry
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.
Interventions
closed lateral internal sphincterotomy was done under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
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.
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
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 61 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal | one year | effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery |
| Relieve of Anal Pain | one year after the procedure | 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) |
Countries
Egypt
Participant flow
Recruitment details
completed , mansoura university hospital
Participants by arm
| Arm | Count |
|---|---|
| Surgical Group Lateral Sphincterotomy underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line. | 21 |
| Glycein Trinitrate Group (21) 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. | 21 |
| Botilinium Toxin Injection All were injected with 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. | 21 |
| Total | 63 |
Baseline characteristics
| Characteristic | Glycein Trinitrate Group | Botilinium Toxin Injection | Surgical Group Lateral Sphincterotomy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 1 Participants | 4.0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 20 Participants | 59.0 Participants |
| Age Continuous | 40 years STANDARD_DEVIATION 7.5 | 40.5 years STANDARD_DEVIATION 3.5 | 41 years STANDARD_DEVIATION 5.5 | 41 years STANDARD_DEVIATION 6.5 |
| Region of Enrollment Egypt | 21 participants | 21 participants | 21 participants | 63.0 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 16 Participants | 47.0 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 5 Participants | 16.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | — / — | — / — | — / — |
| serious Total, serious adverse events | — / — | — / — | — / — |
Outcome results
Primary
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
Time frame: one year
Primary
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)
Time frame: one year after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surgical Group Lateral Sphincterotomy | Relieve of Anal Pain | 4.16 score in scale | Standard Deviation 2.32 |
| Glycein Trinitrate Group | Relieve of Anal Pain | 4.18 score in scale | Standard Deviation 2.52 |
| Botilinium Toxin Injection | Relieve of Anal Pain | 4.2 score in scale | Standard Deviation 2.42 |