Exploration of Standard Surgical Indication in Gallbladder Benign Disease
Study Details
Study Description
Brief Summary
This study evaluates life quality of patients who were diagnosed with gallbladder benign disease through Gastrointestinal Quality of Life Index (GIQLI) scale. Researchers will establish a database including 20,000 patients. Through observational followup and statistic analysis，identifing a model or scale to standardized surgical indication, help surgeons and patients determine the best treatment decision.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The incidence of gallbladder benign diseases are increasing today. Most patients are accepting cholecystectomy. Is it better postoperation for this sort of patients? In other words, there is no specific indication for cholecystectomy in gallbladder benign diseases. Investigators want to explore the specific surgical indication for these patients so that surgeons could help patients make the best decision according to our evaluation model. This model may be a scale that summarizes and quantizes correlative factors of individual, which will be discussed by statisticians and experts of biliary surgery.
Study Design
Outcome Measures
Primary Outcome Measures
- Life Quality (Through GIQLI:Gastrointestinal Quality of Life Index) [Every three months, up to 18 months]
Patients with surgery must including preoperative score
Secondary Outcome Measures
- The Rate of Accidentally Gallbladder Carcinoma During Cholecystectomy [Through study completion, an average of 18 months]
- The Rate of Abdominal Pain After Cholecystectomy [Through study completion, an average of 18 months]
- The Rate of Diarrhea After Cholecystectomy [Through study completion, an average of 18 months]
- The Rate of Abdominal Distension After Cholecystectomy [Through study completion, an average of 18 months]
- Hospital Stay [Through study completion, an average of 18 months]
- Total Expense of Patients Including Medication、Operating Costs and Check-Up Expense [Through study completion, an average of 18 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with gallbladder benign disease, including gallbladder stone、cholecystitis and polypoid lesions of gallbladder from December 2016 to September 2018.
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Have been clearly informed the purpose of this study, methods and other information, voluntarily participate in this study and sign informed consent.
Exclusion Criteria:
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Complicated with bile duct stones and other biliary tract disease or suspected with gallbladder carcinoma、biliary tract cancer.
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Complicated with severe diseases such as organ dysfunction that cannot accept surgery
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Abdominal operation history.
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Pregnant or lactation.
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Coagulopathy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhang Yong | Shanghai | Shanghai | China | 200092 |
Sponsors and Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Shanghai Shen Kang Hospital Development Center
Investigators
- Principal Investigator: Zhaohui Tang, Phd, MD, Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XH-16-034