Protocol summary

Summary
Comparison of the results of endoscopic sinus surgery and Concurrent Endoscopic Sinus Surgery and Rhinoplasty with or without ''Tongue In Groove'' technique . This study is randomised, not blinded, without placebo, interventional and will done with 45 chronic rhinosinusitis patients undergoing rhinoplasty divided in 3 groups of 15 individuals. The first group will be treated by endoscopic sinus surgery alone. The second group will be treated by Concurrent Endoscopic Sinus Surgery and Rhinoplasty with ''Tongue In Groove'' technique and the third group will be treated by Concurrent Endoscopic Sinus Surgery and Rhinoplasty without ''Tongue In Groove'' technique. Inclusion criteria: CRS with or without nasal polyps; no Response to medical treatment; age 15 - 60 Exclusion criteria: Acute infection; Failure to complete medical treatment; immune system disorders; systemic disorders like hypertension, diabetes mellitus, chronic kidney disease and malignancy; pregnancy All three groups will undergo surgery. Patients before surgery and 1, 3 and 6 months after surgery will be evaluated in terms of the width of the middle meatus, edema of the nasal mucosa, Lund Kennedy score in endoscopy, patient satisfaction from the nose, surgeon satisfaction of the nose, difficulty breathing, nasal congestion. The intraoperative blood loss and the duration of surgery will be recorded. Recurrent nasal polyps in the examination 1, 3 and 6 months after surgery will be discussed. Finally, the data will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051128006N1
Registration date: 2017-07-13, 1396/04/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-13, 1396/04/22
Registrant information
Name
Mohamad Sadeghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1628
Email address
sadeghih@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences,Vice chancellor for research
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the results of endoscopic sinus surgery and Concurrent Endoscopic Sinus Surgery and rhinoplasty with or without ''Tongue In Groove'' technique in patients undergoing Endoscopic Sinus Surgery
Public title
Comparing two surgical procedures for Sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: CRS with or without nasal polyps; no Response to medical treatment; age 15 - 60 Exclusion criteria: Acute infection; Failure to complete medical treatment; immune system disorders; systemic disorders like hypertension, diabetes mellitus, chronic kidney disease and malignancy; pregnancy
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization for three interventional groups will done by balanced blocks.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran/ Keshavarz s./ 16azar s./ Tehran university of medical sciences
City
Tehran
Postal code
Approval date
2016-07-24, 1395/05/03
Ethics committee reference number
IR.TUMS.VCR.REC.1395.348

Health conditions studied

1

Description of health condition studied
Chronic rhinosinusitis with or without polyposis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis

Primary outcomes

1

Description
Edema of the nasal mucosa
Timepoint
One day before surgery and 1, 3 and 6 months after that
Method of measurement
Nasal Endoscopy

2

Description
The width of the middle meatus
Timepoint
One day before surgery and 1, 3 and 6 months after that
Method of measurement
Clinical examination and Nasal Endoscopy

3

Description
Endoscopic assessment of the nose
Timepoint
One day before surgery and 1, 3 and 6 months after that
Method of measurement
Nasal endoscopy by the Lund Kennedy scoring system

4

Description
Patient satisfaction from the nose
Timepoint
One day before surgery and 1, 3 and 6 months after that
Method of measurement
Questionnaire

5

Description
Surgeon satisfaction of the nose
Timepoint
One day before surgery and 1, 3 and 6 months after that
Method of measurement
Questionnaire

6

Description
Difficulty breathing
Timepoint
One day before surgery and 1, 3 and 6 months after that
Method of measurement
Questionnaire

Secondary outcomes

1

Description
The duration of surgery
Timepoint
Intraoperative
Method of measurement
The report surgery

2

Description
Blood lost during surgery
Timepoint
Intraoperative
Method of measurement
Questionnaire

3

Description
Recurrent nasal polyps
Timepoint
1,3 and 6 months after surgery
Method of measurement
Nasal endoscopy

4

Description
Nasal congestion
Timepoint
One day before surgery and after that
Method of measurement
Questionnaire

Intervention groups

1

Description
lnterventional group 1: Endoscopic sinus surgery alone
Category
Treatment - Surgery

2

Description
Intervention group 2: Endoscopic sinus surgery and rhinoplasty at the same time, with ''Tongue In Groove'' Technique
Category
Treatment - Surgery

3

Description
Intervention group 3: Endoscopic sinus surgery and rhinoplasty at the same time, without ''Tongue In Groove'' Technique.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Fateme Tavakolnejad
Street address
ENT department, Emam Khomeini hospital, Keshavarz st, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Masud Yunesian
Street address
Office building of Tehran University of Medical Sciences, Keshavarz s., Tehran
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Vice chancellor for research
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
Full name of responsible person
Fateme Tavakolnejad
Position
Assistant ENT
Other areas of specialty/work
Street address
Emam Khomeini hospital, Keshavarz s., Tehran
City
Tehran
Postal code
1419733141
Phone
+98 21 61190
Fax
Email
F.tavakolnejad@gmai.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mmohamad Sadeghi
Position
Faculty member of ENT departmenr
Other areas of specialty/work
Street address
ENT department, Emam Khomeini hospital, Keshavarz s., Tehran
City
Tehran
Postal code
1419733141
Phone
+98 21 61190
Fax
Email
sadeghih@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Tavakolnejad
Position
Resident of ENT department
Other areas of specialty/work
Street address
ENT department, Emam Khomeini hospital, Keshavarz s., Tehran
City
Tehran
Postal code
1419733141
Phone
+98 21 61190
Fax
Email
F.tavakolnejad@gmai.com
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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