History
# Registration date Revision Id
2 2024-07-31, 1403/05/10 310124
1 2020-08-11, 1399/05/21 146686
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  • Protocol summary

    Clinical trial with control group, with parallel group, double-blind, randomized on 164 patients.
    Clinical trial with control group, with parallel group, double-blind, randomized on 72 patients.
    کارآزمایی بالینی دارای گروه کنترل، با گروه موازی، دو سویه کور، تصادفی شده، بر ۱۶۴ بیمار،
    کارآزمایی بالینی دارای گروه کنترل، با گروه موازی، دو سویه کور، تصادفی شده، بر 72 بیمار،
    164 patients who have referred to the department of AmirAl-Momenin hospital in Rasht with diagnosis of primary acquired lacrimal duct obstruction are randomly divided into 2 groups. Both groups will be operated on endoscopically by a specific surgeon.The first postoperative visit will take place in the first week and then in months 1st, 3th, 6th and 12th. All the studied outcomes are examined in all visits.The blinding method was such that during the study period, the surgeon and patients did not have access to random numbers in each block .
    72 patients who have referred to the department of AmirAl-Momenin hospital in Rasht with diagnosis of primary acquired lacrimal duct obstruction are randomly divided into 2 groups. Both groups will be operated on endoscopically by a specific surgeon.The first postoperative visit will take place in the first week and then in months 1st, 3th, 6th and 12th. All the studied outcomes are examined in all visits.The blinding method was such that during the study period, the surgeon and patients did not have access to random numbers in each block .
    164 بیمار که با تشخیص انسداد مجرای اشکی اکتسابی اولیه به بیمارستان امیرالمومنین (ع) رشت مراجعه کرده اند به صورت تصادفی به ۲ گروه مداخله و کنترل تقسیم می شوند. دو گروه توسط یک جراح به روش اندوسکوپی تحت جراحی قرار خواهند گرفت. اولین ویزیت بعد از عمل، در هفته ی اول و سپس در ماههای 1، 3، 6 و 12 صورت خواهد گرفت. تمامی پیامدهای مورد مطالعه، در تمامی ویزیت ها مورد بررسی قرار میگیرند. روش کور‌سازی بدین صورت بود که در مدت زمان اجرای مطالعه، جراح و بیماران به شماره های تصادفی در هر بلوک دسترسی نداشتند.
    72 بیمار که با تشخیص انسداد مجرای اشکی اکتسابی اولیه به بیمارستان امیرالمومنین (ع) رشت مراجعه کرده اند به صورت تصادفی به ۲ گروه مداخله و کنترل تقسیم می شوند. دو گروه توسط یک جراح به روش اندوسکوپی تحت جراحی قرار خواهند گرفت. اولین ویزیت بعد از عمل، در هفته ی اول و سپس در ماههای 1، 3، 6 و 12 صورت خواهد گرفت. تمامی پیامدهای مورد مطالعه، در تمامی ویزیت ها مورد بررسی قرار میگیرند. روش کور‌سازی بدین صورت بود که در مدت زمان اجرای مطالعه، جراح و بیماران به شماره های تصادفی در هر بلوک دسترسی نداشتند.
  • General information

    164
    72
    empty
    Due to the outbreak of the COVID-19 disease, the number of patients referred for DCR surgery decreased significantly, and due to the presence of the oculoplastic specialist, the number of patients referred to the ENT department decreased significantly. As a result, with the decision of the researchers, by changing the diagnostic accuracy of the study from 0.1 to 0.15, the sample size was reduced to 36 people in each group. This change was approved by the university's research committee.
    empty
    به خاطر وقوع بیماری کووید 19 مراجعه بیماران جهت عمل DCR بسیار کم شد و همچنین به خاطر حضور فوق تخصص اکولوپلاستی بیماران مراجعه کننده به بخش ENT بسیار کاهش یافت. در نتیجه با تصمیم محققین با تغییر دقت تشخیصی مطالعه از 0.1 به 0.15 حجم نمونه به 36 نفر در هر گروه کاهش یافت. این تغییر مورد تایید کمیته پژوهشی دانشگاه قرار گرفت.
    After obtaining the informed consent, the mentioned patients are randomly are divided into two groups with and without stenting for surgery. Block randomization method is used to divide patients using of PASS Software. Randomization is performed by a researcher who is not involved in the clinical stages of project. In this method, 164 patients are randomly divided into 41 blocks, with 4 patients in each block, of which 2 are operated with a stent and 2 without a stent. The order of placement of these 4 patients in each block Is also determined randomly. In cases of bilateral lacrimal duct obstruction, each eye is randomized separately. The first group will undergo endoscopic DCR surgery with a stent and second group will have no stent surgery by a specific surgeon. The blinding method was such that during the study, the surgeon and patients did not have access to random numbers in each block.
    After obtaining the informed consent, the mentioned patients are randomly are divided into two groups with and without stenting for surgery. Block randomization method is used to divide patients using of PASS Software. Randomization is performed by a researcher who is not involved in the clinical stages of project. In this method, 72 patients are randomly divided into 9 blocks, with 4 patients in each block, of which 2 are operated with a stent and 2 without a stent. The order of placement of these 4 patients in each block Is also determined randomly. In cases of bilateral lacrimal duct obstruction, each eye is randomized separately. The first group will undergo endoscopic DCR surgery with a stent and second group will have no stent surgery by a specific surgeon. The blinding method was such that during the study, the surgeon and patients did not have access to random numbers in each block.
    بعد از اخذ رضایت آگاهانه، بیماران مذکور جهت جراحی به صورت تصادفی در ۲ گروه با و بدون استنت‌گذاری تقسیم می‌شوند. برای تقسیم بیماران از روش تصادفی سازی بلوکی(Block Randomization) با استفاده از نرم افزار PASS استفاده می‌شود. تصادفی سازی توسط محققی که در مراحل بالینی طرح شرکت ندارد، صورت می‌گیرد. در این روش، ۱۶۴ بیمار مورد مطالعه به صورت تصادفی به ۴۱ بلوک تقسیم می‌شوند که در هر بلوک ۴ بیمار وجود دارد که از این بین ۲ تای آنها با استنت و ۲ تای آنها بدون استنت تحت جراحی قرار می‌گیرند. ترتیب قرارگیری این ۴ بیمار در هر بلوک نیز به صورت تصادفی تعیین می‌شود. در موارد انسداد دو طرفه مجرای اشکی، هر چشم به صورت جداگانه تحت تصادفی سازی قرار می‌گیرد.گروه اول تحت جراحی DCR اندوسکوپیک با استنت و گروه دوم تحت جراحی DCR بدون استنت و همگی توسط یک جراح قرار خواهندگرفت. روش کورسازی بدین صورت بود که در مدت زمان اجرای مطالعه، جراح و بیماران به شماره‌های تصادفی در هر بلوک دسترسی نداشتند.
    بعد از اخذ رضایت آگاهانه، بیماران مذکور جهت جراحی به صورت تصادفی در ۲ گروه با و بدون استنت‌گذاری تقسیم می‌شوند. برای تقسیم بیماران از روش تصادفی سازی بلوکی(Block Randomization) با استفاده از نرم افزار PASS استفاده می‌شود. تصادفی سازی توسط محققی که در مراحل بالینی طرح شرکت ندارد، صورت می‌گیرد. در این روش، 72بیمار مورد مطالعه به صورت تصادفی به 9 بلوک تقسیم می‌شوند که در هر بلوک ۴ بیمار وجود دارد که از این بین ۲ تای آنها با استنت و ۲ تای آنها بدون استنت تحت جراحی قرار می‌گیرند. ترتیب قرارگیری این ۴ بیمار در هر بلوک نیز به صورت تصادفی تعیین می‌شود. در موارد انسداد دو طرفه مجرای اشکی، هر چشم به صورت جداگانه تحت تصادفی سازی قرار می‌گیرد.گروه اول تحت جراحی DCR اندوسکوپیک با استنت و گروه دوم تحت جراحی DCR بدون استنت و همگی توسط یک جراح قرار خواهندگرفت. روش کورسازی بدین صورت بود که در مدت زمان اجرای مطالعه، جراح و بیماران به شماره‌های تصادفی در هر بلوک دسترسی نداشتند.

Protocol summary

Study aim
Comparing of the results of primary endoscopic dacryocystorhinostomy surgery with and without silicon stenting in patients with epiphora
Design
Clinical trial with control group, with parallel group, double-blind, randomized on 72 patients.
Settings and conduct
72 patients who have referred to the department of AmirAl-Momenin hospital in Rasht with diagnosis of primary acquired lacrimal duct obstruction are randomly divided into 2 groups. Both groups will be operated on endoscopically by a specific surgeon.The first postoperative visit will take place in the first week and then in months 1st, 3th, 6th and 12th. All the studied outcomes are examined in all visits.The blinding method was such that during the study period, the surgeon and patients did not have access to random numbers in each block .
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients 18 years of age and older with persistent epiphora or recurrent ocular discharge with primary diagnosis of acquired nasolacrimal duct obstruction. Exclusion Criteria: previous history of nasolacrimal duct surgery؛ suspicion of lacrimal sac malignancy؛ canalicular obstruction requires membranectomy؛ presence of punctum and eyelid ectropion and facial nerve palsy and lid lag؛ history of radiotherapy and trauma and important disease in examined side of the nose and orbit؛ immunodeficiency and uncontrolled systemic diseases؛ congenital dacryocystitis؛ presence of abnormal bleeding disorders.
Intervention groups
The intervention group undergoing endoscopic DCR surgery with a stent and the control group undergoing endoscopic DCR surgery without a stent.
Main outcome variables
Improvement of symptoms; nasolacrimal duct and ostium opening; No dacryocystitis

General information

Reason for update
Due to the outbreak of the COVID-19 disease, the number of patients referred for DCR surgery decreased significantly, and due to the presence of the oculoplastic specialist, the number of patients referred to the ENT department decreased significantly. As a result, with the decision of the researchers, by changing the diagnostic accuracy of the study from 0.1 to 0.15, the sample size was reduced to 36 people in each group. This change was approved by the university's research committee.
Acronym
Dacryocystorhinostomy (DCR)
IRCT registration information
IRCT registration number: IRCT20200718048126N1
Registration date: 2020-08-11, 1399/05/21
Registration timing: prospective

Last update: 2024-08-03, 1403/05/13
Update count: 1
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
Maryam Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3322 5242
Email address
m.akbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing results of primary endoscopic Dacryocystorhinostomy (DCR) surgery with and without silicon stenting in patients with epiphora
Public title
Results of primary endoscopic Dacryocystorhinostomy surgery with and without silicon stenting in patients with epiphora
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 years of age and older with persistent epiphora or recurrent ocular discharge with primary diagnosis of acquired nasolacrimal duct obstruction referred to Amir Al-Momenin hospital of Rasht
Exclusion criteria:
Previous history of nasolacrimal duct surgery, suspicion of lacrimal sac malignancy, canalicular obstruction requires membranectomy, presence of punctum and eyelid ectropion and facial nerve palsy and lid lag, history of Radiotherapy and trauma and important disease in examined side of the nose and orbit, immunodeficiencies and uncontrolled systemic disease, congenital dacryocystitis, presence of abnormal bleeding disorder
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining the informed consent, the mentioned patients are randomly are divided into two groups with and without stenting for surgery. Block randomization method is used to divide patients using of PASS Software. Randomization is performed by a researcher who is not involved in the clinical stages of project. In this method, 72 patients are randomly divided into 9 blocks, with 4 patients in each block, of which 2 are operated with a stent and 2 without a stent. The order of placement of these 4 patients in each block Is also determined randomly. In cases of bilateral lacrimal duct obstruction, each eye is randomized separately. The first group will undergo endoscopic DCR surgery with a stent and second group will have no stent surgery by a specific surgeon. The blinding method was such that during the study, the surgeon and patients did not have access to random numbers in each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
During the study period, the surgeon and patients did not have access to random numbers in each block . Also evaluation in months 1, 3, 6 and 12 by a resident who was unaware of allocation of individuals to the two groups.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
The Old Building of the Faculty of Health, in front of 17 Shahrivar Hospital, Shahid Siadati Ave., Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
4139637459
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.GUMS.REC.1399.086

Health conditions studied

1

Description of health condition studied
Primary acquired nasoLacrimal duct obstruction
ICD-10 code
H04.55
ICD-10 code description
Acquired stenosis of nasolacrimal duct

Primary outcomes

1

Description
Improvement of symptoms; nasolacrimal duct and ostium opening in endoscopy; No dacryocystitis
Timepoint
Patients will be followed up for 12 months. The first postoperative visit will take place in the first week and then in the 1st, 3rd, 6th and 12th months. All the consequences studies are examined in the all Visits. If patients have a stent, it will be removed during the third month visit.
Method of measurement
The studied variables are examined by physical examination and nasal endoscopy in the first week after surgery and then 1st, 3rd, 6th and 12th months.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients undergoing endoscopic DCR surgery with stents placement
Category
Treatment - Surgery

2

Description
Control group: Patients undergoing endoscopic DCR surgery without stents placement
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Akbari Maryam
Street address
Amir Al-Momenin Hospital, 17 Shahrivar Ave., Imam Khomeini Ave.
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 41 3963 7459
Email
M.akbari@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Naghipur Mohammad Reza
Street address
Namjoo, Blvd.Shahid Siadati Ave, Opposite of Sepah Bank, Vice-chancellor for Research Building
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Akbari Maryam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Al-Momenin Hospital, 17 Shahrivar Ave., Imam Khomeini Ave.
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
0098 13 4139637459
Email
M.akbari@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Akbari Maryam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Al-Momenin Hospital, 17 Shahrivar Ave., Imam Khomeini Ave.
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
0098 13 4139637459
Email
M.akbari@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Akbari Maryam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Al-Momenin Hospital, 17 Shahrivar Ave.,Imam Khomeini Ave.
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
0098 13 4139637459
Email
M.akbari@gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
after the end of the study period
When the data will become available and for how long
after the end of the study period
To whom data/document is available
After the end of the study period, the results will be available to the public in the form of articles
Under which criteria data/document could be used
If published as an article
From where data/document is obtainable
ENT Research Center of Guilan University of Medical Sciences
What processes are involved for a request to access data/document
In-person referral or electronic request to the ENT Research Center of Guilan University of Medical Sciences
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