Clinical trial NCT02951169: Exploration of Standard Surgical Indication in Gallbladder Benign Disease
Official title: Multicenter Cohort Study: To Explore the Standard Surgical Indication in Gallbladder Benign Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gallbladder Stone
Cholecystitis
Gallbladder Polyps
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Shen Kang Hospital Development Center
First posted: 2016-11-01
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Diagnosed with Gallbladder Benign Disease.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Life Quality (Through GIQLI:Gastrointestinal Quality of Life Index)
timeFrame: Every three months, up to 18 months
Secondary outcomes:
measure: The Rate of Accidentally Gallbladder Carcinoma During Cholecystectomy
timeFrame: Through study completion, an average of 18 months
measure: The Rate of Abdominal Pain After Cholecystectomy
timeFrame: Through study completion, an average of 18 months
measure: The Rate of Diarrhea After Cholecystectomy
timeFrame: Through study completion, an average of 18 months
measure: The Rate of Abdominal Distension After Cholecystectomy
timeFrame: Through study completion, an average of 18 months
measure: Hospital Stay
timeFrame: Through study completion, an average of 18 months
measure: Total Expense of Patients Including Medication、Operating Costs and Check-Up Expense
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhang Yong
state: Shanghai
Study officials:
affiliation: Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University
name: Zhaohui Tang, Phd, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 BWM, Bilgen EJS, Nieuwenhuijs VB, Hofker HS, Rosman C, Voorburg AM, Bosscha K, van Duijvendijk P, Gerritsen JJ, Heisterkamp J, de Hingh IH, Witteman BJ, Kruyt PM, Scheepers JJ, Molenaar IQ, Schaapherder AF, Manusama ER, van der Waaij LA, van Unen J, Dijkgraaf MG, van Ramshorst B, Gooszen HG, Boerma D; Dutch Pancreatitis Study Group. Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1261-1268. doi: 10.1016/S0140-6736(15)00274-3.
citation: Shabanzadeh DM, Sorensen LT, Jorgensen 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. Epub 2015 Sep 14.
citation: 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 endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial. JAMA. 2014 May;311(20):2101-9. doi: 10.1001/jama.2014.5220.