UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016938
Receipt number R000019661
Scientific Title Anatomical variety of the posterior wall of nasopharynx
Date of disclosure of the study information 2015/04/10
Last modified on 2015/03/27 13:43:15

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Basic information

Public title

Anatomical variety of the posterior wall of nasopharynx

Acronym

Anatomical variety of nasopharynx

Scientific Title

Anatomical variety of the posterior wall of nasopharynx

Scientific Title:Acronym

Anatomical variety of nasopharynx

Region

Japan


Condition

Condition

diseases of neck to the head region

Classification by specialty

Oto-rhino-laryngology Oral surgery Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim is to verify whether recesses on the posterior wall of pharynx contribute retropharyngeal dissection by measurement of multiplanar CT images.

Basic objectives2

Others

Basic objectives -Others

Anatomical characteristics

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

incidence of recesses on the posterior wall of pharynx including orifice of the Eustachian tube, the fossa of Rosenmuller and pharyngeal bursa and pharyngeal tonsil

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

CT images including the neck to the head regions of patients those were examined in departments of oral and maxillofacial surgery, otolaryngology or plastic surgery of Kinki University Hospital

Key exclusion criteria

CT images revealing tumor, swelling or malformation of nasopharyngeal region

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Takasugi

Organization

Kinki University Faculty of Medicine

Division name

Department of Anesthesiology

Zip code


Address

377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan

TEL

072-366-0221

Email

dzc01654@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Takasugi

Organization

Kinki University Faculty of Medicine

Division name

Department of Anesthesiology

Zip code


Address

377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan

TEL

072-366-0221

Homepage URL


Email

dzc01654@nifty.com


Sponsor or person

Institute

Department of Anesthesiology, Kinki University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kinki University Faculty of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 07 Month 16 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This retrospective observation study revealed as follows; the orifice of Eustachian tube and the fossa of Rosenmuller were located at mean distance of 11.1 mm and 7.0 mm from sagittal plane laterally, 6.9 mm and 8.4 mm from nasal base plane vertically, respectively; the shape of the orifice of Eustachian tube was vertically-long ellipse with longitudinal diameter of 9.3 mm and transverse diameter of 6.6 mm; the fossa of Rosenmuller, identified in 89 % of the subjects, was the fossa with 17.8 mm long and 12.7 mm depth. Pharyngeal bursa was found in 15 % of the subjects. The fossa of Rosenmuller is located close to the pathway of insertion of the nasotracheal tube via the nasal cavity, and may contribute to retropharyngeal dissection.


Management information

Registered date

2015 Year 03 Month 27 Day

Last modified on

2015 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019661


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name