Exploration of Standard Surgical Indication in Gallbladder Benign Disease

NCT02951169 | Unknown DMC

• 1 other identifier: XH-16-034
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallbladder Stone; Cholecystitis; Gallbladder Polyps

Outcome Measures

Primary Outcomes (1)

• Life Quality (Through GIQLI:Gastrointestinal Quality of Life Index)

  Patients with surgery must including preoperative score

  Every three months, up to 18 months

Secondary Outcomes (6)

• 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

• Hospital Stay

  Through study completion, an average of 18 months

Interventions

No intervention OTHER

No intervention. Treatment are accordance with clinical practice.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients Diagnosed with Gallbladder Benign Disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Shen Kang Hospital Development Center: collaborator

Study Sites (1)

Zhang Yong

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (3)

• 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.

  PMID: 26460661 RESULT

• 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.

  PMID: 26375367 RESULT

• 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.

  PMID: 24867013 RESULT

MeSH Terms

Conditions

Cholecystolithiasis; Cholecystitis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• Zhaohui Tang, Phd, MD

  Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Tang, Phd, MD

CONTACT

+86 13601789458; tangzhaohui@ahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: November 1, 2016
• Study Start: December 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 1, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)