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Exploration of Standard Surgical Indication in Gallbladder Benign Disease

Multicenter Cohort Study: To Explore the Standard Surgical Indication in Gallbladder Benign Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02951169
Enrollment
20000
Registered
2016-11-01
Start date
2016-12-31
Completion date
2018-12-31
Last updated
2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Gallbladder Polyps, Gallbladder Stone

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.

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.

Interventions

OTHERNo intervention

No intervention. Treatment are accordance with clinical practice.

Sponsors

Shanghai Shen Kang Hospital Development Center
CollaboratorOTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Life Quality (Through GIQLI:Gastrointestinal Quality of Life Index)Every three months, up to 18 monthsPatients with surgery must including preoperative score

Secondary

MeasureTime frame
The Rate of Abdominal Pain After CholecystectomyThrough study completion, an average of 18 months
The Rate of Diarrhea After CholecystectomyThrough study completion, an average of 18 months
The Rate of Accidentally Gallbladder Carcinoma During CholecystectomyThrough study completion, an average of 18 months
Hospital StayThrough study completion, an average of 18 months
Total Expense of Patients Including Medication、Operating Costs and Check-Up ExpenseThrough study completion, an average of 18 months
The Rate of Abdominal Distension After CholecystectomyThrough study completion, an average of 18 months

Countries

China

Contacts

Primary ContactZhaohui Tang, Phd, MD
tangzhaohui@ahoo.com+86 13601789458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026