NCT03880890

Brief Summary

To study the outcome of different two endoscopic sphenoid procedure for management of allergic fungal sphenoidal sinusitis : sphenoidotomy versus sphenoid nasalization with posterior septectomy .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 17, 2019

Last Update Submit

March 17, 2019

Conditions

Fungal Sinusitis

Keywords

sphenoid nasalization

Outcome Measures

Primary Outcomes (1)

  • rate of recurrence

    To assess the effect of nasalization of sphenoid sinus on recurrence rate of allergic fungal sinusitis Recurrence will be evaluated by clinical endoscopic evaluationof regular endoscopic examination first visit after one week,the second after 3 weeks and after 3month. CT nose and paranasal sinus will be done after 3 and 6 months.

    6 month

Secondary Outcomes (1)

  • Type of caustive organism

    2weeks

Study Arms (2)

sphenoidotomy (group A)

ACTIVE COMPARATOR

sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus

Procedure: sphenoidotomy versus sphenoid nasalisation

sphenoid nasalization (group B)

ACTIVE COMPARATOR

sphenoid nasalization in which bilateral extended sphenoidotomy, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway .

Procedure: sphenoidotomy versus sphenoid nasalisation

Interventions

sphenoidotomy versus sphenoid nasalisationPROCEDURE

sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus sphenoid nasalization in which bilateral extended sphenoidotomy, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway .

sphenoid nasalization (group B)sphenoidotomy (group A)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any age.
  • Any case of allergic fungal sinusitis unilateral or bilateral involving the sphenoid sinus

You may not qualify if:

  • Acute invasive fungal sinusitis.
  • Previous Sinonasal surgery.
  • Unfit patient for surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71516, Egypt

Location

Related Publications (6)

  • Chakrabarti A, Denning DW, Ferguson BJ, Ponikau J, Buzina W, Kita H, Marple B, Panda N, Vlaminck S, Kauffmann-Lacroix C, Das A, Singh P, Taj-Aldeen SJ, Kantarcioglu AS, Handa KK, Gupta A, Thungabathra M, Shivaprakash MR, Bal A, Fothergill A, Radotra BD. Fungal rhinosinusitis: a categorization and definitional schema addressing current controversies. Laryngoscope. 2009 Sep;119(9):1809-18. doi: 10.1002/lary.20520.

    PMID: 19544383RESULT

  • Rodrigues J, Caruthers C, Azmeh R, Dykewicz MS, Slavin RG, Knutsen AP. The spectrum of allergic fungal diseases of the upper and lower airways. Expert Rev Clin Immunol. 2016;12(5):531-50. doi: 10.1586/1744666X.2016.1142874. Epub 2016 Feb 19.

    PMID: 26776889RESULT

  • Lee TJ, Huang SF, Chang PH. Characteristics of isolated sphenoid sinus aspergilloma: report of twelve cases and literature review. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):211-7. doi: 10.1177/000348940911800309.

    PMID: 19374153RESULT

  • Kwon MO, Kim KS. Headache induced by isolated sphenoid fungal sinusitis: sinus headache? J Headache Pain. 2009 Dec;10(6):473-6. doi: 10.1007/s10194-009-0153-z. Epub 2009 Sep 10.

    PMID: 19763769RESULT

  • Kieff DA, Busaba N. Treatment of isolated sphenoid sinus inflammatory disease by endoscopic sphenoidotomy without ethmoidectomy. Laryngoscope. 2002 Dec;112(12):2186-8. doi: 10.1097/00005537-200212000-00011.

    PMID: 12461338RESULT

  • Eloy JA, Marchiano E, Vazquez A. Extended Endoscopic and Open Sinus Surgery for Refractory Chronic Rhinosinusitis. Otolaryngol Clin North Am. 2017 Feb;50(1):165-182. doi: 10.1016/j.otc.2016.08.013.

    PMID: 27888912RESULT

Central Study Contacts

hoda abdelkader mohamed, master

CONTACT

+201095974700hoda_abdelhader@yahoo.com

mohammed Azzam Abd ElrazaK, profossor

CONTACT

+201000005651mohammadazzam@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group (A): sphenoidotomy. Group (B): Endoscopic sphenoid nasalization with posterior septectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ENTspechilist

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 19, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2022

Study Completion

October 1, 2022

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

EG(1)