NCT03070808

Brief Summary

The rate of obesity and bariatric surgery is rising steadily. Though Bariatric Surgery Influences on aspects such as endocrin analysis, finance, etc are well tested, quantitative and quality voice impacts have not been evaluated. The aim of the study is to recruit 50 patients who underwent bariatric surgery and compare voice quality in each of these patients before and after surgery.

Trial Health

35
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 all trials

Timeline
Completed

Started Mar 2017

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

February 21, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

March 6, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

February 21, 2017

Last Update Submit

March 3, 2017

Conditions

Obesity, MorbidVoice Alteration

Keywords

obesityvoice

Outcome Measures

Primary Outcomes (1)

  • Stroboscopic evaluation of the larynx

    A visual examination of the larynx

    2/16-2/20

Secondary Outcomes (14)

  • Dysphagia handicap Index

    2/16-2/20

  • EAT 10

    2/16-2/20

  • Voice Handicap Index

    2/16-2/20

  • Average Fundamental frequency

    2/16-2/20

  • Mean Fundamental frequency

    2/16-2/20

  • +9 more secondary outcomes

Eligibility Criteria

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

Adults, 18 years and over, entended for Bariatric Surgery at Kaplan Medicle Center.

You may qualify if:

  • Morbid obese
  • Candidates for bariatric Surgery

You may not qualify if:

  • History of benign \\ malignant disease of the larynx.
  • History of head and neck tumors
  • History of radiation therapy of the neck
  • BMI under 30 pre-surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, MorbidDysphoniaObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVoice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 21, 2017

First Posted

March 6, 2017

Study Start

March 15, 2017

Primary Completion

March 15, 2018

Study Completion

September 15, 2018

Last Updated

March 6, 2017

Record last verified: 2017-02