Trial Outcomes & Findings for Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy (NCT NCT00927849)
NCT ID: NCT00927849
Last Updated: 2009-06-25
Results Overview
effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
one year
Results posted on
2009-06-25
Participant Flow
completed , mansoura university hospital
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy
Baseline characteristics by cohort
| Measure |
Surgical Group Lateral Sphincterotomy
n=21 Participants
underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
|
Glycein Trinitrate Group
n=21 Participants
(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.
|
Botilinium Toxin Injection
n=21 Participants
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.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4.0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
59.0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0.0 Participants
n=4 Participants
|
|
Age Continuous
|
41 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
40 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
41 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
47.0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16.0 Participants
n=4 Participants
|
|
Region of Enrollment
Egypt
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
63.0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one yeareffect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: one year after the procedureusing 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)
Outcome measures
| Measure |
Surgical Group Lateral Sphincterotomy
n=21 Participants
underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
|
Glycein Trinitrate Group
n=21 Participants
(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.
|
Botilinium Toxin Injection
n=21 Participants
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.
|
|---|---|---|---|
|
Relieve of Anal Pain
|
4.16 score in scale
Standard Deviation 2.32
|
4.18 score in scale
Standard Deviation 2.52
|
4.2 score in scale
Standard Deviation 2.42
|
Adverse Events
Surgical Group Lateral Sphincterotomy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glycein Trinitrate Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Botilinium Toxin Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place