Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000312741
Ethics application status
Approved
Date submitted
26/12/2012
Date registered
20/03/2013
Date last updated
24/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Are self-retained laryngoscope and rigid endoscopy more useful than traditional methods for extracting foreign bodies in the entrance of the esophagus?
Scientific title
Are self-retained laryngoscope and rigid endoscopy more useful than traditional methods for extracting foreign bodies in the entrance of the esophagus?
Secondary ID [1] 281494 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracting foreign bodies in the entrance of esophagus 287765 0
Condition category
Condition code
Surgery 288106 288106 0 0
Surgical techniques
Oral and Gastrointestinal 288107 288107 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients who satisfy the inclusion criteria and accept the new type of operation will be divided to the experimental group.The foreign bodies in the entrance of esophagus of the patients will be extracted by self-retained laryngoscope(8587 A, P and KK) and rigid endoscopy(0 degree or 30 degrees Karl Storz Hopkin 8713 AA and BA).The operation will be taken as soon as possible after the routine examinations are done and the approximate duration of the surgical procedure will be about 30 minutes.
Intervention code [1] 286007 0
Treatment: Surgery
Comparator / control treatment
The patients who reject the new type of operation will be divided to the control group.The foreign bodies in the entrance of esophagus of the patients will be extracted by direct laryngoscopy. The operation will be taken as soon as possible after the routine examinations are done and the approximate duration of the surgical procedure will be about 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 288312 0
Foreign bodies are successfully drawn off and the esophagography shows there is no residual foreign body after the operation.
Timepoint [1] 288312 0
24 hours after the operation.
Secondary outcome [1] 299845 0
Foreign bodies slippe down into the stomach in the operation and the gastroscopy or colonoscopy shows the foreign bodies are in the gastrointestinal tract.
Timepoint [1] 299845 0
24 hours after the operation.

Eligibility
Key inclusion criteria
1, Informed consent of patients.
2.Foreign bodies in the entrance of esophagus, especially for those small Sharp-pointed objects embedded in submucosa.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.The patients who had serious preoperative dyspnea.
2.The objects lodged below this entrance of the esophagus.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4667 0
China
State/province [1] 4667 0
Guangdong

Funding & Sponsors
Funding source category [1] 286280 0
Government body
Name [1] 286280 0
National Natural Science Foundation of China
Country [1] 286280 0
China
Primary sponsor type
Individual
Name
Lei wenbin
Address
Zhong shan 2nd Road 58,
Guangzhou 510080
Country
China
Secondary sponsor category [1] 285073 0
Individual
Name [1] 285073 0
Wen weiping
Address [1] 285073 0
Zhong shan 2nd Road 58,
Guangzhou 510080
Country [1] 285073 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288350 0
Institutional Review Board of the First Affiliated Hospital of Sun Yat-sen University
Ethics committee address [1] 288350 0
Zhong shan 2nd Road 58,
Guangzhou 510080.
Ethics committee country [1] 288350 0
China
Date submitted for ethics approval [1] 288350 0
Approval date [1] 288350 0
Ethics approval number [1] 288350 0

Summary
Brief summary
Foreign bodies in the entrance of esophagus, especially for those small Sharp-pointed objects embedded in submucosa are formidable clinical emergency. Currently, flexible endoscopy is usually use for objects lodged below this area. Rigid esophagoscopy or direct laryngoscopy are alternative surgical methods, but neither of them could smooth the crimping mucosa and expose the area completely, nor combine with an rigid endoscopy expediently. Improvements in surgical methods are therefore necessary for foreign bodies at this area.Self-retained laryngoscope combine with rigid endoscopy are common used in laryngeal lesion treatment. Self-retained Karl Storz laryngoscope(8587 A, P and KK )have a long lip which can support the cricoid lamina, and expose the entrance of esophagus,completely, then 0 degree or 30 degrees Karl Storz Hopkins rigid endoscopy (8713 AA and BA) are used to check the area carefully. Small Foreign bodies even the sharp-pointed objects embedded in submucosa will be found easily.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34917 0
Prof Lei wenbin
Address 34917 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Country 34917 0
China
Phone 34917 0
+86-20-87333733
Fax 34917 0
+86-20-87333733
Email 34917 0
[email protected]
Contact person for public queries
Name 18164 0
Prof Lei wenbin
Address 18164 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Country 18164 0
China
Phone 18164 0
+86-20-87333733
Fax 18164 0
+86-20-87333733
Email 18164 0
[email protected]
Contact person for scientific queries
Name 9092 0
Prof Lei wenbin
Address 9092 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Country 9092 0
China
Phone 9092 0
+86-20-87333733
Fax 9092 0
+86-20-87333733
Email 9092 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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