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| ID | Type | Description | Link |
|---|---|---|---|
| DVO005 2555-CV1837 | Other Identifier | Universidad del Rosario Research Ethics Committee |
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| Name | Class |
|---|---|
| Universidad del Rosario | OTHER |
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The BACILO study was designed with the objective of having robust data on local epidemiological bacterial colonisation information on bile cultures with patients taken to laparoscopic cholecystectomy in our institution to find which predictive factors are associated with culture positivity and antibiotic resistance patterns. Secondary endpoints include evaluating demographical, clinical and surgical variables and establishing comparison between both positive and negative bile cultures and between antibiotic sensitive and resistant microorganism strain isolations.
BACILO is single-centre, observational, analytical, prospective study with a prognostic prediction model with the objective of identifying predictive factors associated with microbial and antibiotic resistance patterns in bile cultures of patients taken to laparoscopic cholecystectomy in our institution. Primary outcomes are bile culture positivity and phenotypical resistance antibiogram patterns while secondary outcomes include demographic, clinical and surgical characteristics and surgical outcomes. The main objective is to determine predictive factors using a prediction model, variables included are: Age, diabetes mellitus, C-reactive protein test, choledocholithiasis/ERCP, cholecystitis and severity of cholecystitis according to the 2018 Tokyo guidelines.This in the nature of describing the relationship between bile culture positivity and phenotypical antibiogram resistance patterns in our institution, and establish thus better treatment strategies based on higher quality local evidence.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bile culture and phenotypic antibiogram resistance test | Diagnostic Test | Extraction of 3-5ml of bile from surgical specimen (gallbladder) to be taken for bacterial culture testing and phenotypical antibiogram resistance if positive |
| Measure | Description | Time Frame |
|---|---|---|
| Bile culture positivity | Bile culture is tested positive for at least one (1) microorganism | Perioperatively, during the procedure and immediately after the intervention |
| Phenotypical antibiogram resistance | If bile culture is positive, evaluation for possible antibiotic resistance vs sensitivity | Perioperatively, during the procedure and immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial characteristics | To describe the microbial characteristics of the bile cultures and their phenotypical antibiogram resistance | Immediately after the intervention |
| Bile culture and antibiotic resistance relationship |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that are over 18 years that have an indication for laparoscopic cholecystectomy in our institution without any of the exclusion criteria, which had bile cultures taken from the surgical specimen (gallbladder) during the surgery and attended the postoperative15 day follow-up appointment after hospital discharge.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Mayor-Méderi | Bogota | Cundinamarca | 111221 | Colombia | ||
| Hospital Universitario Méderi Barrios Unidos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31586461 | Background | Dyrhovden R, Ovrebo KK, Nordahl MV, Nygaard RM, Ulvestad E, Kommedal O. Bacteria and fungi in acute cholecystitis. A prospective study comparing next generation sequencing to culture. J Infect. 2020 Jan;80(1):16-23. doi: 10.1016/j.jinf.2019.09.015. Epub 2019 Oct 2. | |
| 33153472 | Background | Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppaniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x. |
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Data obtained and input into the database is anonymous, without any individual or identifying characteristics will be stored in a dataset from the Centro de Recursos para el Aprendizaje y la Investigación, property of and administered by the Universidad del Rosario as a plan of data management. Moreover, the different codes used in the analysis will be stored in this dataset.
It is in our plans once we obtain a register number from Clinical Trials in order to publish the protocol, statistical analysis plan and clinical study report in a scientific journal so it will be available to all people interested.
It is in our plans to be published in a scientific journal available to all people interested.
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3-5cm of bile will be extracted from the surgical specimen (gallbladder), during laparoscopic cholecystectomy to be taken for bacterial cultures and phenotypical antibiogram resistance pattern if it is positive.
Explore the relationship between positive bile cultures and phenotypical antibiogram resistance with surgical outcomes
| Immediately after the intervention |
| Demographical and clinical characteristics | To describe and compare the demographic and clinical characteristics of the study population. | Pre-intervention |
| Surgical characteristics and outcomes | To describe and compare the surgical characteristics and outcomes of the study population | During the 15 day postoperative follow-up appointment |
| Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis) | To determine demographic and clinical predictive factors for positive bile cultures and phenotypical antibiogram resistance. | Through study completion, around 1 year and a half |
| Bogota |
| Cundinamarca |
| 111221 |
| Colombia |
| 18369670 | Background | Galili O, Eldar S Jr, Matter I, Madi H, Brodsky A, Galis I, Eldar S Sr. The effect of bactibilia on the course and outcome of laparoscopic cholecystectomy. Eur J Clin Microbiol Infect Dis. 2008 Sep;27(9):797-803. doi: 10.1007/s10096-008-0504-8. Epub 2008 Mar 28. |
| 34088947 | Background | Yoon JH, Paik KY, Chung HY, Oh JS. Clinical implication of bactibilia in moderate to severe acute cholecystitis undergone cholecystostomy following cholecystectomy. Sci Rep. 2021 Jun 4;11(1):11864. doi: 10.1038/s41598-021-91261-9. |
| 26328034 | Background | van der Linden YT, Bosscha K, Prins HA, Lips DJ. Single-port laparoscopic cholecystectomy vs standard laparoscopic cholecystectomy: A non-randomized, age-matched single center trial. World J Gastrointest Surg. 2015 Aug 27;7(8):145-51. doi: 10.4240/wjgs.v7.i8.145. |
| 29090866 | Background | Gomi H, Solomkin JS, Schlossberg D, Okamoto K, Takada T, Strasberg SM, Ukai T, Endo I, Iwashita Y, Hibi T, Pitt HA, Matsunaga N, Takamori Y, Umezawa A, Asai K, Suzuki K, Han HS, Hwang TL, Mori Y, Yoon YS, Huang WS, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, de Santibanes E, Shikata S, Noguchi Y, Wada K, Honda G, Supe AN, Yoshida M, Mayumi T, Gouma DJ, Deziel DJ, Liau KH, Chen MF, Liu KH, Su CH, Chan ACW, Yoon DS, Choi IS, Jonas E, Chen XP, Fan ST, Ker CG, Gimenez ME, Kitano S, Inomata M, Mukai S, Higuchi R, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):3-16. doi: 10.1002/jhbp.518. Epub 2018 Jan 9. |
| 33412630 | Background | Wu ZY, Wu XS, Yao WY, Wang XF, Quan ZW, Gong W. [Pathogens' distribution and changes of antimicrobial resistance in the bile of acute biliary tract infection patients]. Zhonghua Wai Ke Za Zhi. 2021 Jan 1;59(1):24-31. doi: 10.3760/cma.j.cn112139-20200717-00559. Chinese. |
| 33610257 | Background | Manrai M, Jha AA, Singh Shergill SP, Thareja S, Sood AK, Shukla R, Jain R, Dhiman P, Gaurab. Microbiology of bile in extrahepatic biliary obstruction: A tropical experience. Indian J Med Microbiol. 2021 Jan;39(1):54-58. doi: 10.1016/j.ijmmb.2020.10.002. Epub 2020 Dec 4. |
| 36804057 | Background | Lee JM, Kang JS, Choi YJ, Byun Y, Jin SH, Yoon KC, Lee HW, Jang JY, Lim CS. Suggested use of empirical antibiotics in acute cholecystitis based on bile microbiology and antibiotic susceptibility. HPB (Oxford). 2023 May;25(5):568-576. doi: 10.1016/j.hpb.2023.01.017. Epub 2023 Feb 3. |
| 33860354 | Background | Kaplan U, Handler C, Chazan B, Weiner N, Hatoum OA, Yanovskay A, Kopelman D. The Bacteriology of Acute Cholecystitis: Comparison of Bile Cultures and Clinical Outcomes in Diabetic and Non-Diabetic Patients. World J Surg. 2021 Aug;45(8):2426-2431. doi: 10.1007/s00268-021-06107-2. Epub 2021 Apr 15. |
| 34540214 | Background | Shafagh S, Rohani SH, Hajian A. Biliary infection; distribution of species and antibiogram study. Ann Med Surg (Lond). 2021 Sep 7;70:102822. doi: 10.1016/j.amsu.2021.102822. eCollection 2021 Oct. |
| 31359494 | Background | Jang DK, Kim J, Park WB, Yi SY, Lee JK, Yoon WJ. Increasing burden of biliary tract infection caused by extended-spectrum beta-lactamase-producing organisms in Korea: A nationwide population-based study. J Gastroenterol Hepatol. 2020 Jan;35(1):56-64. doi: 10.1111/jgh.14809. Epub 2019 Aug 13. |
| 39486833 | Derived | Ramirez-Giraldo C, Rodriguez Barbosa C, Isaza-Restrepo A, Avendano-Morales V, Rojas-Lopez S, Van-Londono I. Predictive factors associated with Bile culture positivity And phenotypiCal antIbiogram resistance patterns in patients taken to LaparOscopic cholecystectomy (BACILO): protocol for a prospective observational cohort study and development of a prognostic prediction model. BMJ Open. 2024 Nov 1;14(10):e086655. doi: 10.1136/bmjopen-2024-086655. |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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