Subjective and Objective Outcome of Septoplasty With or W... | NCT05698940

Studies
Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy

NCT05698940

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Dec 1, 2023Actual

Enrollment

35Estimated

Phase

Not Applicable

Conditions

Nasal Blockage
Nasal Obstruction
Septum; Deviation

Interventions

Infundibultomy

Countries

Switzerland

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2016Actual

Primary Completion Date

Jul 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 27, 2022

First Submission Date that Met QC Criteria

Jan 16, 2023

First Posted Date

Jan 26, 2023Actual

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

Nov 30, 2023

Last Update Posted Date

Dec 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 is one of the most common procedures in rhinology. In many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. Often the reason given for this is the improvement of the functional outcome in terms of better nasal breathing, although there is no evidence for this. If a significantly better outcome can be shown, one would have a first evidence for the extended procedure.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infundibulotomy	Active Comparator	Infundibulotomy on one side of sinuses	Procedure: Infundibultomy
No Infundibultomty	Sham Comparator	No Intervention on other side of sinuses	Procedure: Infundibultomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infundibultomy	Procedure	Infundibultomy on one side of patient	Infundibulotomy No Infundibultomty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Single sided VAS Scores for breathing impairment	Rating of nasal breating on a 0-10 scale	3 months

Secondary Outcomes

Measure	Description	Time Frame
SNOT Score	Quality of Life Measure from 0-110	3 months
NOSE Score	Nasal symptom questionnaire	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral breathing impairment due to septal deviation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zurich University Hospital	Recruiting	Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015508	Nasal Obstruction

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D000402	Airway Obstruction
D012131	Respiratory Insufficiency

Browse Leaves

Not provided

Browse Branches

Not provided