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Effect of mitomycine C on DCR (Dacryosystorhinostomy) with endonasal endoscopic guidance in lacrimal duct stenosis referring to medical center affiliated to Kashan university of medical sciences

Protocol summary

Summary
Effect of Mitomycine C on DCR (Dacryosystorhinostomy) with endonasal endoscopic guidance examine in a double blind accidental survey. Patients with lacrimal duct stenosis referring to medical centers affiliated to Kashan university of medical sciences who aged 35-65 years old and tearing along with (Recurrent acute dacryocystitis, increase in lacrimal minisc, have a reflux when the pressure on the lacrimal sac, Confirmed the diagnosis of nasolacrimal lavage selected. Patient with history: tearing at birth, trauma to face and nose, Nasal and sinus surgery, Mucosal lacrimal sac, canalicole obstruction, Coagulation disorders, hemophilia, other external nasal disease, lacrimal sac neoplasm, Corneal ulcers or foreign body on cornea, abnormality in ponctum position are excluded from study. Sample size 92 patients calculate (46 for each group). During surgery sponge impregnated with 0.02 precent mitomycin C use in osteotomy site for five minutes and then Washed with 50 cc normal saline and clean with endonasal endoscopic guidance. For control group use placebo instead of Mitomycine C. epiphoria follow.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014010816136N1
Registration date: 2014-05-18, 1393/02/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-05-18, 1393/02/28
Registrant information
Name
Fatemeh Rangraz Jeddi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 8883
Email address
rangrazejeddi_f@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mitomycine C on DCR (Dacryosystorhinostomy) with endonasal endoscopic guidance in lacrimal duct stenosis referring to medical center affiliated to Kashan university of medical sciences
Public title
Effect of mitomycine C on DCR (Dacryosystorhinostomy)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 35-65 years old and tearing along with (Recurrent acute dacryocystitis); increase in lacrimal minisc; have a reflux when the pressure on the lacrimal sac; confirmed the diagnosis of nasolacrimal lavage selected. Patient with history of tearing at birth, trauma to face and nose, nasal and sinus surgery, mucosal lacrimal sac, canalicole obstruction, coagulation disorders, hemophilia, other external nasal disease, lacrimal sac neoplasm, corneal ulcers or foreign body on cornea, abnormality in ponctum position are excluded from study.
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ravand avenue
City
Kashan
Postal code
Approval date
2013-08-13, 1392/05/22
Ethics committee reference number
29/5/1/1869

Health conditions studied

1

Description of health condition studied
Stenosis of lacrimal passages
ICD-10 code
H04.5
ICD-10 code description
Stenosis and insufficiency of lacrimal passages

Primary outcomes

1

Description
Tearing
Timepoint
One week, one month, six months after surgery
Method of measurement
yes/no

Secondary outcomes

1

Description
Tearing reflex
Timepoint
One day, one week, one month and six months
Method of measurement
no/ purulent/ aqueous

Intervention groups

1

Description
During surgery sponge impregnated with 0.02 precent mitomycin C use in osteotomy site for five minutes and then Wash with 50 cc normal saline and clean with endonasal endoscopic guidance.
Category
Treatment - Drugs

2

Description
For control group Dacryosystorhinostomy under general anesthesia is routinely performed with placebo instead of Mitomycine C
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical centers affiliated to Kashan University of Medical Sciences
Full name of responsible person
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Kashan University of Medical Sciences, research deputy- Ravand avenue
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Rangraz Jeddi
Position
Facuty member
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ravand avenue
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
+98 36 1555 8883
Email
angrazejeddi_f@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Shaeri
Position
Ophtalmologist
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ravand avenue
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
shaeri_m@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Rangraz Jeddi
Position
PhD of Health Information Management
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ravand avenue
City
Kashan
Postal code
Phone
+98 36 1555 8883
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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