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

History of Changes

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
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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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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 ]

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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

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Other Adverse Events

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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:

Aysan E, Aren A, Ayar E. A prospective, randomized, controlled trial of primary wound closure after lateral internal sphincterotomy. Am J Surg. 2004 Feb;187(2):291-4.

Brisinda G, Maria G, Bentivoglio AR, Cassetta E, Gui D, Albanese A. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med. 1999 Jul 8;341(2):65-9. Erratum in: N Engl J Med 1999 Aug 19;341(8):624.

Orsay C, Rakinic J, Perry WB, Hyman N, Buie D, Cataldo P, Newstead G, Dunn G, Rafferty J, Ellis CN, Shellito P, Gregorcyk S, Ternent C, Kilkenny J 3rd, Tjandra J, Ko C, Whiteford M, Nelson R; Standards Practice Task Force; American Society of Colon and Rectal Surgeons. Practice parameters for the management of anal fissures (revised). Dis Colon Rectum. 2004 Dec;47(12):2003-7. No abstract available.

Neill ME, Swash M. Chronic perianal pain: an unsolved problem. J R Soc Med. 1982 Feb;75(2):96-101.

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

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