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Exploration of Standard Surgical Indication in Gallbladder Benign Disease

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Cholecystitis
Gallbladder Polyps
Gallbladder Stone

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT02951169
XH-16-034

Details and patient eligibility

About

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.

Full 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.

Enrollment

20,000 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients diagnosed with gallbladder benign disease, including gallbladder stone、cholecystitis and polypoid lesions of gallbladder from December 2016 to September 2018.
  • Have been clearly informed the purpose of this study, methods and other information, voluntarily participate in this study and sign informed consent.

Exclusion criteria

  • Complicated with bile duct stones and other biliary tract disease or suspected with gallbladder carcinoma、biliary tract cancer.
  • Complicated with severe diseases such as organ dysfunction that cannot accept surgery
  • Abdominal operation history.
  • Pregnant or lactation.
  • Coagulopathy.

Trial contacts and locations

1

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Central trial contact

Zhaohui Tang, Phd, MD

Data sourced from clinicaltrials.gov

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