Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgical group lateral sphincterotomy | Active Comparator | underwent closed lateral internal sphincterotomy (LIS) under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line. |
|
| Glycerin trinitrate group | Active Comparator | 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. |
|
| botulinum toxin injection | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lateral internal sphincterotomy (LIS) | Procedure | closed lateral internal sphincterotomy was done under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year |
| 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) | one year after the procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ayman elnakeeb, MD | Mansoura University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayman Elnakeeb | Al Mansurah | 335111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14769323 | Result | 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. doi: 10.1016/j.amjsurg.2003.11.011. | |
| 10395629 | Result | 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. doi: 10.1056/NEJM199907083410201. |
Not provided
Not provided
Not provided
completed , mansoura university hospital
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Glycein Trinitrate Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Not Posted | Mean | Standard Deviation | mmhg | 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) | Posted | Mean | Standard Deviation | score in scale |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ayman elnakeeb | Mansoura university hospital | 0020106752021 | elnakeebayman@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D000074722 | Lateral Internal Sphincterotomy |
| D005996 | Nitroglycerin |
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000074432 | Sphincterotomy |
| D000074433 | Myotomy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Glycerin trinitrate (GTN) | Drug | 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. |
|
|
| botulinum toxin injection (BTX A) | Drug | 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. |
|
|
| 15657647 | Result | 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. doi: 10.1007/s10350-004-0785-7. No abstract available. |
| 7069679 | Result | Neill ME, Swash M. Chronic perianal pain: an unsolved problem. J R Soc Med. 1982 Feb;75(2):96-101. doi: 10.1177/014107688207500205. |
(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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| one year after the procedure |
|
|
|
| EG001 | 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. |
| EG002 | 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. |
Not provided
Not provided
Not provided
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |