• Investigating the Results of Betamethasone Ophthalmic Ointment in Polypoid Frontal Sinus in Endoscopic Sinus Surgery and Its Effect in Reducing the Recurrence of Polyposis After Surgery
The results of using betamethasone ophthalmic ointment in polypoid frontal sinus in endoscopic sinus surgery and its effect in reducing polyp recurrence after surgery.
Design
• Two arm parallel group randomized trial with blinded postoperative care and outcome assessment with generating random numbers in 30 patients
Settings and conduct
30 patients with bilateral polypoid frontal sinuses with almost the same size were selected in a certain period of time in two teaching hospitals of Iran University of Medical Sciences. Two visits are made after surgery. The first visit is one and a half months and the second visit is after three months in order to check the endoscopic indicators of discharge/inflammation/polyps (DIP) and sinus CT scan. In this study, betamethasone ophthalmic ointment is placed inside the sinus using frontal sinus suction after opening the frontal recess on the side of intervention. The patient and outcome evaluator are blinded by double masked blind method.
Participants/Inclusion and exclusion criteria
Bilateral polypoid frontal sinus,
The size of frontal sinuses should be approximately the same in each patient,
No allergy to corticosteroides,
No previous surgery of frontal sinus
Intervention groups
In one patient, one frontal sinus is considered as the control group and the other side as the intervention group. In the intervention group, betamethasone ophthalmic ointment is used after polyp removal. In the control group, only the polyp is removed.
Main outcome variables
Polyp; Inflammation; Edema; Discharge; Opacification in CT Scan; Soft tissue density ratio in CT Scan
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220510054810N1
Registration date:2023-05-21, 1402/02/31
Registration timing:retrospective
Last update:2023-05-21, 1402/02/31
Update count:0
Registration date
2023-05-21, 1402/02/31
Registrant information
Name
Zeinab Emamgholizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3362 0386
Email address
l.med.tbz90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
2022-09-23, 1401/07/01
Actual recruitment end date
2023-04-19, 1402/01/30
Trial completion date
2023-05-10, 1402/02/20
Scientific title
• Investigating the Results of Betamethasone Ophthalmic Ointment in Polypoid Frontal Sinus in Endoscopic Sinus Surgery and Its Effect in Reducing the Recurrence of Polyposis After Surgery
Public title
•" Investigating the Effect of Betamethasone Ophthalmic Ointment in Reducing the Recurrence of Polyposis After Frontal Sinus Surgery"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Bilateral Polypoid Frontal sinus
The size of the frontal sinuses should be approximately the same in each patient.
No allergy to corticosteroides
Exclusion criteria:
Previous surgery of the frontal sinus
Allergy to corticosteroides
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Randomly, in one participant, one frontal sinus is the control sample and the other sinus is the intervention sample.
Actual sample size reached:
30
More than 1 sample in each individual
Actual sample size in each individual:
2
Randomly, in one participant, one frontal sinus is the control sample and the other sinus is the intervention sample
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is by random number generation method so that right frontal sinus is selected with odd numbers and left frontal sinus with even numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients know that betamethasone ointment is used in sinus surgery, but they don't know if it is left or right.
The evaluator of the result does not know which side the betamethasone ointment was used on.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical science
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-04-06, 1400/01/17
Ethics committee reference number
IR.IUMS.FMD.REC.1400.037
Health conditions studied
1
Description of health condition studied
Polyp recurrence after sinus surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Polyp recurrence
Timepoint
After surgery, two visits are performed, the first one after one and a half months and the second one after three months in order to check the endoscopic parameters including polyps/inflammation/discharges and CT scan indicators of the sinuses.
Method of measurement
Using endoscopic examination and polyp, inflammation, discharge ( PID) criteria and sinus CT scan to measure soft tissue density ratio (STDR)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients with bilateral frontal sinus polyps are selected according to the initial CT scan. Right or left sinus is randomly selected as intervention group. Betamethasone ophthalmic ointment of Iran Najo Pharmaceutical Company 0.1%, 3 grams is used in all patients, which contains 3 milligrams of corticosteroids. After performing Draf 2a surgery in both the control and interventional frontal sinuses in all patients, 3 grams of betamethasone ophthalmic ointment is placed inside the frontal sinus suction and enters the interventional side at the end of the surgery. Ointment is not used in the control sinus. In post-surgery treatment, patients receive budesonide intranasal corticosteroid spray every 12 hours and washing serum. None of the patients receive oral corticosteroids after surgery.
Category
Treatment - Drugs
2
Description
Control group: In this group, during endoscopic sinus surgery, only polyps are removed, and we perform draf 2 a surgery. Betamethasone ointment is not used.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Zeinab Emamgholizadeh
Street address
Rasool Akram Hospital, Niyayesh St., Sattarkhan St.