Exploration of Standard Surgical Indication in Gallbladder Benign Disease

• Conditions: Cholecystitis; Gallbladder Polyps; Gallbladder Stone

• Registration Number: NCT02951169
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-28
• Last Update Submitted: 2016-10-28
• Study First Posted: 2016-11-01
• Last Update Posted: 2016-11-01
• Study Start: 2016-12
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Hospital Stay	Through study completion, an average of 18 months
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
Total Expense of Patients Including Medication、Operating Costs and Check-Up Expense	Through study completion, an average of 18 months

Trial Locations

Locations (1)

Zhang Yong; 🇨🇳 Shanghai, Shanghai, China