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IRCT20151123025202N47 IRCT 2025-08-08 Hamedan University of Medical Sciences Adhesion of the middle nasal meatus and position of the middle turbinate in patients with chronic sinusitis with polyposis, after surgery Comparison of middle nasal meatus adhesion and middle turbinate position in patients with chronic sinusitis with polyposis, after functional endoscopic sinus surgery (FESS) in the modified splint and control groups 2025-09-06 anticipated 53 Recruiting https://irct.ir/trial/85368 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a card number is prepared and 53 letters are written on IR and 53 letters are written on IL, each of which is placed in an envelope with an aluminum cover, the lid is taped and placed in a box. When the patients arrive, one of the envelopes will be randomly selected and opened by the ward nurse. If the selected letters are IR, the right nostril will be corrected by the splint and the left will be the control group. If the selected letters are IL, the left nostril will be corrected by the splint and the right will be the control group. 2-3 Chronic sinusitis with polyposis. Intervention 1: Intervention group: A modified splint is used on the intervention side. A phenylephrine-impregnated patch is placed in the nose to establish hemostasis, and then it is removed during recovery. In these patients, a 2 mm thick Richard brand silastic splint is used. After the surgery is completed, the distance from the columella edge to the axilla is measured using a surgical ruler, and then the splint is cut half to one centimeter longer than the measurement from the distal end. The upper edge of the splint is resected to locate the maximum thickness of the splint in the middle meatus (spacer). After the splint is cut and trimmed, it is inserted under the vision of the endoscope in such a way that the distal part of the middle meatus space is completely subaxillary. Then the splint is sutured and fixed at two points using 3-0 nylon cut sutures, and then it is evaluated again by the endoscope to ensure correct placement. Then a phenylephrine-impregnated patch is inserted to establish hemostasis. It is removed during recovery. Intervention 2: Control group: In the control group or contralateral nose, the modified splint is not used. Yes - There is a plan to make this available What will be shared: All data can be shared except for authors names When: From 2026 onwards it is permissible To whom: Clinical professionals and Researchers in all fields Conditions: For treatment of patients and develop research and science Where to obtain: Correspond to the email address of the scientific responsible for the study How to obtain: Send and receive email Comments:
public Abbas Moradi
Shahid Fahmideh
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0557 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Javaneh Jahanshahi
Shahid Beheshti Blv
Hamadan Iran (Islamic Republic of) 6514845411 009881338274184 Besat@Umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Chronic sinusitis with bilateral nasal polyps Failure to respond to drug treatment Age 18 years and above Patient consent to participate in the study 18 years no limit Both Previous history of endoscopic sinus surgery Allergic fungal sinusitis Known cases of primary immunodeficiency Patients requiring septoplasty Need more packing with mesh J32 Chronic sinusitis Treatment - Devices Rehabilitation Intervention group: A modified splint is used on the intervention side. A phenylephrine-impregnated patch is placed in the nose to establish hemostasis, and then it is removed during recovery. In these patients, a 2 mm thick Richard brand silastic splint is used. After the surgery is completed, the distance from the columella edge to the axilla is measured using a surgical ruler, and then the splint is cut half to one centimeter longer than the measurement from the distal end. The upper edge of the splint is resected to locate the maximum thickness of the splint in the middle meatus (spacer). After the splint is cut and trimmed, it is inserted under the vision of the endoscope in such a way that the distal part of the middle meatus space is completely subaxillary. Then the splint is sutured and fixed at two points using 3-0 nylon cut sutures, and then it is evaluated again by the endoscope to ensure correct placement. Then a phenylephrine-impregnated patch is inserted to establish hemostasis. It is removed during recovery. Control group: In the control group or contralateral nose, the modified splint is not used. Adhesions of the middle nasal meatus. Timepoint: 7 days, 1 month, and 3 months after surgery. Method of measurement: Nasal endoscopy and viewing endoscopic images. Nasal discharge and crusting. Timepoint: 7 days, 1 month, and 3 months after surgery. Method of measurement: Ask the patient about an intranasal examination. Recurrence of sinusitis. Timepoint: One month and 3 months after surgery. Method of measurement: Clinical examination, patient questioning, sinus endoscopy. Hamedan University of Medical Sciences Approved 2025-05-24 Ethics committee of Hamadan Univercity of Medical Science Sahahid Fahmideh Hamadan Hamadan Iran (Islamic Republic of)