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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010669
Receipt No. R000012476
Scientific Title SHOULD WE PERFORM ROUTINE UPPER GI ENDOSCOPY BEFORE CHOLECYSTECTOMY?
Date of disclosure of the study information 2013/05/10
Last modified on 2013/05/08

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Basic information
Public title SHOULD WE PERFORM ROUTINE UPPER GI ENDOSCOPY BEFORE CHOLECYSTECTOMY?
Acronym ENDOSCOPY BEFORE CHOLECYSTECTOMY: IS IT NECESSARY?
Scientific Title SHOULD WE PERFORM ROUTINE UPPER GI ENDOSCOPY BEFORE CHOLECYSTECTOMY?
Scientific Title:Acronym ENDOSCOPY BEFORE CHOLECYSTECTOMY: IS IT NECESSARY?
Region
Asia(except Japan) Europe

Condition
Condition In some patients,there isn't any symptomatic relief after cholecystectomy due to the overlap of the symptoms of biliary and gastroduodenal pathologies. This condition is also known as postcholecystectomy syndrome. The usual reason for the lack of relief after cholecystectomy is the incorrect diagnosis of chronic cholecystitis. The one and only characteristic symptom of chronic cholecystitis is biliary colic. The reasons for the syndrome are gastroduodenitis, inadequate stone extraction, biliary stasis, inflammation and strictures.
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effectiveness of upper gastrointestinal endoscopy in all patients with epigastric and abdominal pain in the right upper quadrant regardless of ultrasound findings.
Basic objectives2 Others
Basic objectives -Others Basic objective is to evaluate the effectiveness of upper GI endoscopy before cholecystectomy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The main outcome of the study is to evaluate the necessity of performing routine upper GI endoscopy before cholecystectomy. Our results show that it isn't because if you take biliary colic as the one and only symptom of indication for cholecystectomy, the ratio of post-cholecystectomy syndrome is %3-5 and the reason is %50 organic.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Patients underwent upper GI endoscopy before cholecystectomy/Patients underwent cholecystectomy without preoperative endoscopy
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
19 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria Patients with cholelithiasis who underwent preoperative upper GI endoscopy and not.
Key exclusion criteria Patients underwent upper GI endoscopy without cholelithiasis.
Target sample size 194

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Emre Gunay
Organization Haydarpasa Numune Research and Training Hospital
Division name General Surgery
Zip code
Address T&#305;bbiye Cad. Haydarpasa Numune Hastanesi Uskudar Istanbul Turkey
TEL 902164144502
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Haydarpasa Numune Research and Training Hospital
Division name General Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Haydarpasa Numune Research and Training Hospital
Institute
Department

Funding Source
Organization Haydarpasa Numune Research and Training Hospital
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
2013 Year 05 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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 08 Day
Last modified on
2013 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012476

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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