UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010669 |
|---|---|
| Receipt number | 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 15:46:13 |
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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
Tıbbiye Cad. Haydarpasa Numune Hastanesi Uskudar Istanbul Turkey
TEL
902164144502
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
Sponsor or person
Institute
Haydarpasa Numune Research and Training Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012476
