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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039054
Receipt No. R000044538
Scientific Title Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions
Date of disclosure of the study information 2020/01/05
Last modified on 2020/01/05

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Basic information
Public title Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions
Acronym Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions
Scientific Title Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions
Scientific Title:Acronym Utility of the sliding lung sign for the prediction of preoperative intrathoracic adhesions
Region
Japan

Condition
Condition To assess the potential of the ultrasonographic sliding lung sign to detect severe intrathoracic adhesions before surgery.
Classification by specialty
Surgery in general Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the potential of the ultrasonographic sliding lung sign to detect severe intrathoracic adhesions before surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess the potential of the ultrasonographic sliding lung sign to detect severe intrathoracic adhesions before surgery.
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria all patients aged 20 to 89 years who were admitted for elective thoracic surgery
Key exclusion criteria pneumothorax, hydrothorax, hemothorax, pyothorax, chylothorax, median sternotomy, psychiatric disorders that inhibited participation, and inappropriate participation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Homma
Organization Joetsu General Hospital
Division name Division of Thoracic Surgery
Zip code 9438507
Address 616 Daido-Fukuda, Joetsu, Niigata
TEL 025-524-3000
Email hommat@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Homma
Organization Joetstu General Hospital
Division name Division of Thoracic Surgery
Zip code 9438507
Address 616 Daido-Fukuda, Joetsu, Niigata
TEL 025-524-3000
Homepage URL
Email hommat@med.u-toyama.ac.jp

Sponsor
Institute Joestu General Hospital
Institute
Department

Funding Source
Organization None
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 Joetsu General Hospital
Address 616 Daido-Fukuda, Joetsu, Niigata
Tel 025-524-3000
Email hommat@med.u-toyama.a.jp

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
2020 Year 01 Month 05 Day

Related information
URL releasing protocol https://joetsu-hp.jp
Publication of results Partially published

Result
URL related to results and publications https://joetsu-hp.jp
Number of participants that the trial has enrolled 168
Results
 All 15 patients without the sliding lung sign had hard severe adhesions [specificity 100%, sensitivity 88.2%, positive predictive value 100%, negative predictive value 98.7%, and area under curve 0.94]. There were two false-negative results, both of which were soft adhesions.  Thoracotomy frequency, intraoperative bleeding, operative time, and postoperative hospitalization were significantly greater in these patients than in those with non-severe adhesions.  
Results date posted
2020 Year 01 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In total, 269 patients were assessed for eligibility, 101 of whom were excluded after the application of exclusion criteria. A total of 168 patients consented to participate and were enrolled. No patient withdrew from the study
Participant flow
In total, 269 patients were assessed for eligibility, 101 of whom were excluded after the application of exclusion criteria. A total of 168 patients consented to participate and were enrolled. No patient withdrew from the study
Adverse events
nothing
Outcome measures
The ultrasound sliding lung sign could be used to predict severe intrathoracic adhesions before surgery. Preoperative confirmation of the ultrasound sliding lung sign is important for planning surgical approaches and implementing appropriate safety management.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
2013 Year 04 Month 01 Day
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2020 Year 01 Month 05 Day
Last modified on
2020 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044538

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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