Nasal Resonance Change After Endoscopic Endonasal Transsp... | NCT02828514

Studies
Nasal Resonance Change After Endoscopic Endonasal Transsphenoidal Skull Base Surgery: Analysis of Quality of Voice

NCT02828514

Sponsor

Khon Kaen University

Status

Unknown status

Last Update Posted

Feb 3, 2017Estimated

Enrollment

46Estimated

Phase

Not provided

Conditions

Voice Quality
Endoscopic Pituitary Surgery

Interventions

Not provided

Countries

Thailand

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

Feb 2017

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

Sep 2015Actual

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Jul 2, 2016

First Submission Date that Met QC Criteria

Jul 7, 2016

First Posted Date

Jul 11, 2016Estimated

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

Feb 2, 2017

Last Update Posted Date

Feb 3, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pornthep Kasemsiri, Department of Otorhinolaryngology, Khon Kaen UniversityPrincipal Investigator

Lead Sponsor

Khon Kaen UniversityOTHER

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this study is to determine nasal resonance change after endoscopic endonasal transsphenoidal skull base surgery. Furthermore, the quality of voice is assessed, also.

Detailed Description

Not provided

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

46Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nasal resonance change after endoscopic endonasal transsphenoidal surgery which was assessed by computer speech lab		Two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent endoscopic endonasal transsphenoidal skull base surgery

Exclusion Criteria:

Patients under 18 year
Patients cannot following command including loss of conscious
Patients cannot speak including patient on tracheostomy tube
Patients who has nasal tumor, nasal polyp, sinusitis
Patients who has cleft lip cleft palate or submucosal cleft
Patients who underwent adenotonsillectomy or palatoplasty in same setting with endoscopic pituitary surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent endoscopic endonasal transsphenoidal skull base surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pornthep Kasemsiri, MD.	Contact			Pkasemsiri99@gmail.com
Cattleya Thongrong, MD.	Contact			Jupiters66@gmail.com

Overall Officials

Name	Affiliation	Role
Pornthep Kasemsiri, MD.	Khon Kaen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Khon Kaen University	Recruiting	Khon Kaen	Khon Kean	40002	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34938862	Derived	Kasemsiri P, Duangthongphon P, Prathanee B, Thongrong C. Nasal resonance changes after endoscopic endonasal transsphenoidal skull base surgery: Analysis of voice quality. Laryngoscope Investig Otolaryngol. 2021 Nov 19;6(6):1275-1282. doi: 10.1002/lio2.701. eCollection 2021 Dec.