Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00927849
First received: March 23, 2009
Last updated: May 7, 2009
Last verified: May 2009
Results First Received: March 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Hypertensive Anal Canal
Interventions: Procedure: lateral internal sphincterotomy (LIS)
Drug: Glycerin trinitrate (GTN)
Drug: botulinum toxin injection (BTX A)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
completed , mansoura university hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Surgical Group Lateral Sphincterotomy     Glycein Trinitrate Group     Botilinium Toxin Injection  
STARTED     21     21     21  
COMPLETED     21     21     21  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Surgical Group Lateral Sphincterotomy     Glycein Trinitrate Group     Botilinium Toxin Injection     Total  
Number of Participants  
[units: participants]
  21     21     21     63  
Age  
[units: participants]
       
<=18 years     1     2     1     4  
Between 18 and 65 years     20     19     20     59  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41  ± 5.5     40  ± 7.5     40.5  ± 3.5     41  ± 6.5  
Gender  
[units: participants]
       
Female     16     15     16     47  
Male     5     6     5     16  
Region of Enrollment  
[units: participants]
       
Egypt     21     21     21     63  



  Outcome Measures

1.  Primary:   Relieve of Anal Pain   [ Time Frame: one year after the procedure ]

2.  Primary:   Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal   [ Time Frame: one year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: ayman elnakeeb
Organization: Mansoura university hospital
phone: 0020106752021
e-mail: elnakeebayman@yahoo.com


Publications of Results:

Responsible Party: ayman el nakeeb, Mansoura University hospital
ClinicalTrials.gov Identifier: NCT00927849     History of Changes
Other Study ID Numbers: hypertensive anal canal
Study First Received: March 23, 2009
Results First Received: March 23, 2009
Last Updated: May 7, 2009
Health Authority: Egypt: Institutional Review Board