Exploration of Standard Surgical Indication in Gallbladder Benign Disease

Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02951169
• Other study ID #: XH-16-034
• Status: Not yet recruiting
• Phase: N/A
• First received: October 25, 2016
• Last updated: October 28, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Zhaohui Tang, Phd, MD
• Phone: +86 13601789458
• Email: tangzhaohui[@]ahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallbladder Polyps
• Gallbladder Stone
• Gallstones

Intervention

Other:
• No intervention
No intervention. Treatment are accordance with clinical practice.

Locations

Country	Name	City	State
China	Zhang Yong	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai Shen Kang Hospital Development Center

Country where clinical trial is conducted

China, 

References & Publications (3)

Cotton PB, Durkalski V, Romagnuolo J, Pauls Q, Fogel E, Tarnasky P, Aliperti G, Freeman M, Kozarek R, Jamidar P, Wilcox M, Serrano J, Brawman-Mintzer O, Elta G, Mauldin P, Thornhill A, Hawes R, Wood-Williams A, Orrell K, Drossman D, Robuck P. Effect of en — View Citation

da Costa DW, Bouwense SA, Schepers NJ, Besselink MG, van Santvoort HC, van Brunschot S, Bakker OJ, Bollen TL, Dejong CH, van Goor H, Boermeester MA, Bruno MJ, van Eijck CH, Timmer R, Weusten BL, Consten EC, Brink MA, Spanier BW, Bilgen EJ, Nieuwenhuijs VB — View Citation

Shabanzadeh DM, Sørensen LT, Jørgensen T. A Prediction Rule for Risk Stratification of Incidentally Discovered Gallstones: Results From a Large Cohort Study. Gastroenterology. 2016 Jan;150(1):156-167.e1. doi: 10.1053/j.gastro.2015.09.002. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Life Quality (Through GIQLI:Gastrointestinal Quality of Life Index)	Patients with surgery must including preoperative score	Every three months, up to 18 months	No
Secondary	The Rate of Accidentally Gallbladder Carcinoma During Cholecystectomy		Through study completion, an average of 18 months	No
Secondary	The Rate of Abdominal Pain After Cholecystectomy		Through study completion, an average of 18 months	No
Secondary	The Rate of Diarrhea After Cholecystectomy		Through study completion, an average of 18 months	No
Secondary	The Rate of Abdominal Distension After Cholecystectomy		Through study completion, an average of 18 months	No
Secondary	Hospital Stay		Through study completion, an average of 18 months	No
Secondary	Total Expense of Patients Including Medication?Operating Costs and Check-Up Expense		Through study completion, an average of 18 months	No