Nasal Packing Duration and Development of Pharyngitis Aft... | NCT06291402

Studies
Nasal Packing Duration and Development of Pharyngitis After Septorhinoplasty Surgery

NCT06291402

Sponsor

Al-Azhar University

Status

Recruiting

Last Update Posted

Jan 6, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Rhinitis

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2024Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Feb 26, 2024

First Submission Date that Met QC Criteria

Feb 26, 2024

First Posted Date

Mar 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2026

Last Update Posted Date

Jan 6, 2026Actual

Name	Class
Benha University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Septoplasty or septal reconstruction is a corrective surgical procedure performed to straighten the nasal septum. It may be associated with numerous complications. To minimize these complications, both nasal cavities are frequently packed with different types of nasal packing. In our study we will try to find relationship between duration of nasal packing and postrhinoplasty sore throat and pharyngitis.

Detailed Description

Nasal packing affects swallowing by different mechanisms. It may affect swallowing as a result of nasal congestion, constant mouth breathing, throat dryness and pharyngitis.

Postoperative sore throat causes patient dissatisfaction and poor pain control. Several interventions could be performed to reduce sore throat and pharyngitis and increase patient satisfaction , which may not be convenient for all patients, such as gargling or sprays

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sore throat	The incidence of Sore throat will be graded as 0 = Nil, 1 = Mild, 2 = Moderate and 3 = Severe as possible.	48 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Dysphagia	The incidence of Dysphagia will be recorded	48 hours postoperatively
Throat irritation	The incidence of throat irritation will be recorded

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I and II patients
aged from 20 to 40 years old
undergo septorhinoplasty

Exclusion Criteria:

Bleeding disorders
Uncontrolled hypertension
Cardiovascular diseases
Uncontrolled diabetes mellitus
Collagen disorders
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

100 ASA I and II patients aged from 20 to 40 years old will undergo septorhinoplasty in Benha university hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Neveen Kohaf, Ph.D	Contact	+201060383012		nevenabdo@azhar.edu.eg
Neveen Kohaf	Contact	+201060383012		nevenabdo@azhar.edu.eg

Overall Officials

Name	Affiliation	Role
Neveen Kohaf, ph.d	Al-Azhar University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neveen Kohaf	Recruiting	Tanta	Egypt	11865	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be shared upon reasonable request from the principle investigator

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012220	Rhinitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided