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Comparing two surgical procedures for Sinusitis

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017051128006N1
Enrollment
45
Registered
2017-07-13
Start date
2016-08-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic rhinosinusitis with or without polyposis. Chronic sinusitis

Interventions

Intervention 1: lnterventional group 1: Endoscopic sinus surgery alone. Intervention 2: Intervention group 2: Endoscopic sinus surgery and rhinoplasty at the same time, with ''Tongue In Groove'' Techn
Treatment - Surgery
lnterventional group 1: Endoscopic sinus surgery alone
Intervention group 2: Endoscopic sinus surgery and rhinoplasty at the same time, with ''Tongue In Groove'' Technique
Intervention group 3: Endoscopic sinus surgery and rhinoplasty at the same time, without ''Tongue In Groove'' Technique.

Sponsors

Tehran University of Medical Sciences, Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Edema of the nasal mucosa. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Nasal Endoscopy.;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.;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.;Patient satisfaction from the nose. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Questionnaire.;Surgeon satisfaction of the nose. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Questionnaire.;Difficulty breathing. Timepoint: One day before surgery and 1, 3 and 6 months after that. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
The duration of surgery. Timepoint: Intraoperative. Method of measurement: The report surgery.;Blood lost during surgery. Timepoint: Intraoperative. Method of measurement: Questionnaire.;Recurrent nasal polyps. Timepoint: 1,3 and 6 months after surgery. Method of measurement: Nasal endoscopy.;Nasal congestion. Timepoint: One day before surgery and after that. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Tavakolnejad

Tehran University of Medical Sciences

F.tavakolnejad@gmai.com+98 21 61190

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026