Endoscopic Direct "Draf IIa" (Carolyn's Window Approach) Versus Endoscopic Angled "Draf IIa"Approach in Chronic Rhinosinusitis With Frontal Sinus Affection ( A Comparative Study ).

NCT06668844 | Not Yet Recruiting DMC

• 1 other identifier: Endoscopic direct Draf IIa
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with chronic rhinosinusitis with frontal sinus affection indicated for sinuscopy will be randomly categorized in 2 groups: group A will have endoscopic directDraf IIa frontal sinusotomy and group B will have endoscopic angled Draf IIa frontal sinusotomy, the two groups will be compared according to ostium patency and perioperative morbidity

Conditions

Chronic Rhinosinusitis (CRS); Frontal Sinusitis; Draf I or IIa; Functional Endoscopic Sinus Surgery (FESS)

Keywords

Frontal sinusitis; Direct Draf; Endoscopic sinus surgery

Outcome Measures

Primary Outcomes (1)

• Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy.

  Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy assessment will be done radiologically after 6 months : it will be considered patent if ostium more than 5mm

  2 years

Secondary Outcomes (1)

• Assess perioperative morbidity of endoscopic direct Draf IIa approach compared to endoscopic Draf IIa frontal sinusotomy with an angled endoscope and instrumentation

  2 years

Study Arms (2)

First arm

EXPERIMENTAL

Endoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy

Procedure: Endoscopic direct Draf IIa

Second arm

ACTIVE COMPARATOR

Endoscopic angled Draf IIa frontal sinuaotomy

Procedure: Endoscopic angled Draf IIa

Interventions

Endoscopic direct Draf IIa PROCEDURE

Endoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy

First arm

Endoscopic angled Draf IIa PROCEDURE

Group BFrontal sinusotomy using angled endoscopeand instruments

Second arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients (aged 18 and above) with chronic rhino sinusitis affecting the frontal sinus with or without nasal polyps confirmed by nasal endoscopy and CT scan.
• Unilateral or bilateral cases.
• Denovo or recurrent cases.

You may not qualify if:

• Individuals younger than 18 year-old.
• Neoplasms

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Barham HP, Hall CA, Hernandez SC, Zylicz HE, Stevenson MM, Zito BA, Harvey RJ. Impact of Draf III, Draf IIb, and Draf IIa frontal sinus surgery on nasal irrigation distribution. Int Forum Allergy Rhinol. 2020 Jan;10(1):49-52. doi: 10.1002/alr.22447. Epub 2019 Dec 11.

  PMID: 31826329 BACKGROUND

• Spielman DB, Kim M, Overdevest J, Gudis DA. Zero-Degree Endoscopic Visualization of the Frontal Sinus Predicts Improved Topical Irrigation Delivery. Laryngoscope. 2021 Feb;131(2):250-254. doi: 10.1002/lary.28654. Epub 2020 Apr 11.

  PMID: 32277702 BACKGROUND

• Seresirikachorn K, Sit A, Png LH, Kalish L, Campbell RG, Alvarado R, Harvey RJ. Carolyn's Window Approach to Unilateral Frontal Sinus Surgery. Laryngoscope. 2023 Oct;133(10):2496-2501. doi: 10.1002/lary.30569. Epub 2023 Jan 18.

  PMID: 36651461 BACKGROUND

• Weber R, Draf W, Kratzsch B, Hosemann W, Schaefer SD. Modern concepts of frontal sinus surgery. Laryngoscope. 2001 Jan;111(1):137-46. doi: 10.1097/00005537-200101000-00024.

  PMID: 11192882 BACKGROUND

• Hajbeygi M, Nadjafi A, Amali A, Saedi B, Sadrehosseini SM. Frontal Sinus Patency after Extended Frontal Sinusotomy Type III. Iran J Otorhinolaryngol. 2016 Sep;28(88):337-343.

  PMID: 27738610 BACKGROUND

• Pagella F, Maiorano E, Turri-Zanoni M, Ferrari M, Carena P, Zoia C, Czaczkes C, Conti C, Schreiber A, Battaglia P, Emanuelli E, Pelucchi S, Bignami M, Nicolai P, Castelnuovo P. The role of the osteoplastic flap in the endoscopic era: a retrospective multicentre experience on revision surgery. Acta Otorhinolaryngol Ital. 2023 Apr;43(Suppl. 1):S34-S40. doi: 10.14639/0392-100X-suppl.1-43-2023-04.

  PMID: 37698098 BACKGROUND

• Wormald PJ, Bassiouni A, Callejas CA, Kennedy DW, Citardi MJ, Smith TL, Orlandi RR, Kaschke O, Siow JK, Szczygielski K, Lund V, Fokkens W, Psaltis AJ. The International Classification of the radiological Complexity (ICC) of frontal recess and frontal sinus. Int Forum Allergy Rhinol. 2017 Apr;7(4):332-337. doi: 10.1002/alr.21893. Epub 2016 Dec 5.

  PMID: 27918154 BACKGROUND

MeSH Terms

Conditions

Frontal Sinusitis

Condition Hierarchy (Ancestors)

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Hazem Gamal Noreldin, Assistant lecturer

CONTACT

01024806122; Hazzmnoreldin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share