NCT02828514

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.

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
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

July 2, 2016

Last Update Submit

February 2, 2017

Conditions

Voice QualityEndoscopic Pituitary Surgery

Outcome Measures

Primary Outcomes (1)

  • Nasal resonance change after endoscopic endonasal transsphenoidal surgery which was assessed by computer speech lab

    Two years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent endoscopic endonasal transsphenoidal skull base surgery

You may qualify if:

  • Patients who underwent endoscopic endonasal transsphenoidal skull base surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen University

Khon Kaen, Khon Kean, 40002, Thailand

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34938862DERIVED

Study Officials

  • Pornthep Kasemsiri, MD.

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pornthep Kasemsiri, MD.

CONTACT

Pkasemsiri99@gmail.com

Cattleya Thongrong, MD.

CONTACT

Jupiters66@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Otorhinolaryngology

Study Record Dates

First Submitted

July 2, 2016

First Posted

July 11, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

TH(1)