Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00927849
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 3
• Duration (Months): 68
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertensive Anal Canal	Procedure: lateral internal sphincterotomy (LIS); Drug: Glycerin trinitrate (GTN); Drug: botulinum toxin injection (BTX A)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: surgical group lateral sphincterotomy underwent closed lateral internal sphincterotomy (LIS) under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.	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.
Active Comparator: Glycerin trinitrate group 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.	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
Active Comparator: botulinum toxin injection 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.	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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 61 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ayman Elnakeeb	Mansoura		Egypt	335111

Sponsors and Collaborators

• Mansoura University

Investigators

• Principal Investigator: ayman elnakeeb, MD, Mansoura University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mansoura university

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00927849
• Other Study ID Numbers: hypertensive anal canal
• First Posted: Jun 25, 2009
• Last Update Posted: Jun 25, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: anal hypertonia; sphincterotomy; incontinence; manometry
• Additional relevant MeSH terms: Nitroglycerin; Botulinum Toxins; Glycerol

Study Results

Participant Flow

Recruitment Details	completed , mansoura university hospital

Arm/Group Title	Surgical Group Lateral Sphincterotomy	Glycein Trinitrate Group	Botilinium Toxin Injection
Arm/Group Description	underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.	(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.	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.
Period Title: Overall Study
STARTED	21	21	21
COMPLETED	21	21	21
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Surgical Group Lateral Sphincterotomy	Glycein Trinitrate Group	Botilinium Toxin Injection	Total
Arm/Group Description	underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.	(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.	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 of all reporting groups
Overall Participants	21	21	21	63
Age (Count of Participants)
<=18 years	1 4.8%	2 9.5%	1 4.8%	4.0 6.3%
Between 18 and 65 years	20 95.2%	19 90.5%	20 95.2%	59.0 93.7%
>=65 years	0 0%	0 0%	0 0%	0.0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (5.5)	40 (7.5)	40.5 (3.5)	41 (6.5)
Sex: Female, Male (Count of Participants)
Female	16 76.2%	15 71.4%	16 76.2%	47.0 74.6%
Male	5 23.8%	6 28.6%	5 23.8%	16.0 25.4%
Region of Enrollment (participants) [Number]
Egypt	21 100%	21 100%	21 100%	63.0 100%

Outcome Measures

1. Primary Outcome

Title	Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal
Description	effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Primary Outcome

Title	Relieve of Anal Pain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surgical Group Lateral Sphincterotomy	Glycein Trinitrate Group	Botilinium Toxin Injection
Arm/Group Description	underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.	(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.	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.
Measure Participants	21	21	21
Mean (Standard Deviation) [score in scale]	4.16 (2.32)	4.18 (2.52)	4.2 (2.42)

Adverse Events

Arm/Group Title	Surgical Group Lateral Sphincterotomy		Glycein Trinitrate Group		Botilinium Toxin Injection
Arm/Group Description	underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.		(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.		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.

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.