Partial Lateral Internal Sphincterotomy Versus Combined Botulinum Toxin A Injection and Topical Application of Diltiazem in treatment of chronic anal fissure
Objectives: A randomized control trial is performed to compare efficacy and complications of combined topical diltiazem (DTZ) gel and botulinum toxin A injection (BTA) versus partial lateral internal sphincterotomy (PLIS).management of chronic anal fissure remains a challenging issue. PLIS provides high cure rate with the expense of considerable risk of incontinence. DTZ and BTA have been widely used for medical sphincterotomy. However, no study has compared the effectiveness of combined DTZ and BTA with PLIS.Setting: This study conducts at Sina hospital. Design and intervention: 99 patients will randomly assigned to receive combined topical DTZ ointment and BTA injection or partial lateral internal incterotomy (PLIS) . Participants including major eligibility criteria: Diagnosis of chronic anal fissure on physical examination (based on having indurations at the edges and having at least two criteria of these three including skin tag, hypertrophied anal papillae and exposed internal sphincter muscle fiber) by an experienced
colorectal surgeon associated with painful defecation for at least 2 month.
Main outcome measure variables: Efficacy and complications following each treatment will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042812294N3
Registration date:2013-10-21, 1392/07/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-21, 1392/07/29
Registrant information
Name
Reza Heydari
Name of organization / entity
School of Medicine, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7780 7967
Email address
heydari@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Partial Lateral Internal Sphincterotomy Versus Combined Botulinum Toxin A Injection and Topical Application of Diltiazem in treatment of chronic anal fissure
Public title
Partial Lateral Internal Sphincterotomy Versus Combined Botulinum Toxin A Injection and Topical Application of Diltiazem in Treatment of Chronic Anal Fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of chronic anal fissure on physical examination (based on having indurations at the edges and having at least two criteria of these three including skin tag; hypertrophied anal papillae and exposed internal sphincter muscle fiber) by an experienced
colorectal surgeon associated with painful defecation for at least 2 month; age between 18 and 100 years old.
Exclusion criteria:
acute anal fissure (experiencing symptoms less than two months); pregnancy; secondary anal fissure; hypersensitivity to DTZ or BTA; cardiovascular disease; previous history of anal surgery; atypical fissure and chronic headache.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences.
Street address
1136746911, Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
Induration, hypertrophied papilla, exposing internal anal sphincter,skin tag
Timepoint
before and after surgery
Method of measurement
physical examination
3
Description
pain
Timepoint
before treatment, 1 week, 1,2,6 and 12 months postoperatively
Method of measurement
visual analog scale
4
Description
chronicity of fissure
Timepoint
before treatment
Method of measurement
history taking
5
Description
fissure localization
Timepoint
before treatment
Method of measurement
physical examination
6
Description
bleeding
Timepoint
before treatment, 1 week, 1,2,6 and 12 months postoperatively
Method of measurement
history taking
7
Description
pain at night
Timepoint
before treatment, 1 week, 1,2,6 and 12 months postoperatively
Method of measurement
history taking
8
Description
recurrence
Timepoint
1 ,2,6 and 12 month postoperatively
Method of measurement
history taking and physical examination
Intervention groups
1
Description
Intervention group: Under local anesthesia (with lidocaine 5% gel) on left sided or knee elbow position. BTA is injected into the internal anal sphincter on the both sides of anterior midline in equal doses. These patients will be advised to receive 2% DTZ ointment three times daily for six weeks which applied to the perianal region and anus.
Category
Treatment - Drugs
2
Description
Control group:
under spinal anesthesia in the lithotomy position; internal sphincter muscle fibers were partially
cut at 3 o’clock position under direct visualization with a transverse incision up to the height of
the fissure apex using a cautery. In this study, skin tags and hypertrophied anal papillae were also
removed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Ahmadi-amoli
Street address
1136746911, Sina Hospital, Hasanabad Sq.,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotouhi
Street address
1417613151, Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Medical School
Full name of responsible person
Reza Heydari
Position
Medical student
Other areas of specialty/work
Street address
1136746911, Sina Hospital, Hasanabad Sq.,Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
heidari.reza1@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Sina Hospital, Surgery Department
Full name of responsible person
Dr Ahmadiamoli
Position
Associate Professor
Other areas of specialty/work
Street address
1136746911, Sina Hospital, Hasanabad Sq.,Tehran
City
Tehran
Postal code
Phone
+98 912 105 5822
Fax
Email
ahmadiam@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences,School of medicine
Full name of responsible person
Atefeh Zeinoddini
Position
medical Student
Other areas of specialty/work
Street address
1136746911, Sina Hospital, Hasanabad Sq.,Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
atefe.zeinoddini@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)