Top

Langenbeck's Archives of Surgery

Published in:

Open Access 01-12-2020 | Cholecystitis | Controlled Clinical Trials

Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial

Authors: Gona Jaafar, Gabriel Sandblom, Lars Lundell, Folke Hammarqvist

Published in: Langenbeck's Archives of Surgery | Issue 8/2020

Abstract

Purpose

Evidence supporting the value of preoperative antibiotic prophylaxis (PAP) in surgery for acute cholecystitis is lacking. This study aimed to shed light on whether PAP in acute cholecystectomy for cholecystitis reduces the postoperative infectious complication (PIC) rate. Secondary outcomes were the prevalence of bacteriobilia, CRP values and leucocyte counts.

Methods

The study was performed as a single-centre, double-blinded, placebo-controlled, randomised study. Patients with acute cholecystitis amenable for acute laparoscopic cholecystectomy were randomly assigned to either PAP (piperacillin/ tazobactam) or placebo, and the subsequent clinical course was followed.

Results

A total of 106 patients were enrolled, 16 of whom were excluded due to protocol violation. PIC developed in 22 of the 90 patients included with no significant difference between the PAP and placebo groups (8 patients in the PAP group and 14 in the placebo arm, p = 0.193). The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups.

Conclusion

PAP does not affect the risk for PIC in patients with acute cholecystitis. The major risk factors determining PIC in these patients need defining, in particular, the impact of bacteriobilia.

Trial registration

The study was registered at clinicaltrials.gov (NCT02619149) December 2, 2015.

Lammert F, Gurusamy K, Ko CW, Miquel JF, Mendez-Sanchez N, Portincasa P et al (2016) Gallstones. Nat Rev Dis Primers 2:17CrossRef

Khalid S, Iqbal Z, Bhatti AA (2017) Early versus delayed laparoscopic cholecystectomy for acute cholecystitis. J Ayub Med Coll Abbottabad 29(4):570–573PubMed

Kolla SB, Aggarwal S, Kumar A, Kumar R, Chumber S, Parshad R, Seenu V (2004) Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective randomized trial. Surg Endosc 18(9):1323–1327CrossRef

Gutt CN, Encke J, Köninger J, Harnoss JC, Weigand K, Kipfmüller K, Schunter O, Götze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schön MR, Seitz HK, Daniel D, Stremmel W, Büchler MW (2013) Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg 258(3):385–393CrossRef

Enochsson L, Thulin A, Osterberg J, Sandblom G, Persson G (2013) The Swedish Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks): a nationwide registry for quality assurance of gallstone surgery. JAMA Surg 148(5):471–478CrossRef

Regimbeau JM, Fuks D, Pautrat K, Mauvais F, Haccart V, Msika S, Mathonnet M, Scotté M, Paquet JC, Vons C, Sielezneff I, Millat B, Chiche L, Dupont H, Duhaut P, Cossé C, Diouf M, Pocard M, FRENCH Study Group (2014) Effect of postoperative antibiotic administration on postoperative infection following cholecystectomy for acute calculous cholecystitis: a randomized clinical trial. Jama. 312(2):145–154CrossRef

Csendes A, Burdiles P, Maluenda F, Diaz JC, Csendes P, Mitru N (1996) Simultaneous bacteriologic assessment of bile from gallbladder and common bile duct in control subjects and patients with gallstones and common duct stones. Arch Surg 131(4):389–394CrossRef

Nitzan O, Brodsky Y, Edelstein H, Hershko D, Saliba W, Keness Y, Peretz A, Chazan B (2017) Microbiologic data in acute cholecystitis: ten years’ experience from bile cultures obtained during percutaneous cholecystostomy. Surg Infect 18(3):345–349CrossRef

Arminanzas C, Tigera T, Ferrer D, Calvo J, Herrera LA, Pajaron M et al (2016) Role of bacteriobilia in postoperative complications. Rev Esp Quimioterapia 29(3):123–129

10.

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 WSW, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, de Santibañes 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, Giménez ME, Kitano S, Inomata M, Mukai S, Higuchi R, Hirata K, Inui K, Sumiyama Y, Yamamoto M (2018) Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci 25(1):3–16CrossRef

11.

Darkahi B, Sandblom G, Liljeholm H, Videhult P, Melhus A, Rasmussen IC (2014) Biliary microflora in patients undergoing cholecystectomy. Surg Infect 15(3):262–265CrossRef

12.

Jaafar G, Darkahi B, Lindhagen L, Persson G, Sandblom G (2017) Disparities in the regional, hospital and individual levels of antibiotic use in gallstone surgery in Sweden. BMC Surg 17(1):128CrossRef

13.

Sarkut P, Kilicturgay S, Aktas H, Ozen Y, Kaya E (2017) Routine use of prophylactic antibiotics during laparoscopic cholecystectomy does not reduce the risk of surgical site infections. Surg Infect 18:603–609CrossRef

14.

Passos MA, Portari-Filho PE (2016) Antibiotic prophylaxis in laparoscopic cholecistectomy: is it worth doing? Arq Bras Cir Dig 29(3):170–172CrossRef

15.

Vohra RS, Hodson J, Pasquali S, Griffiths EA, Chole SSG (2017) West Midlands Res C. Effectiveness of antibiotic prophylaxis in non-emergency cholecystectomy using data from a population-based cohort study. World J Surg 41(9):2231–2239CrossRef

16.

Murri R, De Belvis AG, Fantoni M, Tanzariello M, Parente P, Marventano S et al (2016) Impact of antibiotic stewardship on perioperative antimicrobial prophylaxis. Int J Qual Health Care 28(4):502–507CrossRef

17.

Ansaloni L, Pisano M, Coccolini F, Peitzmann AB, Fingerhut A, Catena F, Agresta F, Allegri A, Bailey I, Balogh ZJ, Bendinelli C, Biffl W, Bonavina L, Borzellino G, Brunetti F, Burlew CC, Camapanelli G, Campanile FC, Ceresoli M, Chiara O, Civil I, Coimbra R, de Moya M, di Saverio S, Fraga GP, Gupta S, Kashuk J, Kelly MD, Khokha V, Jeekel H, Latifi R, Leppaniemi A, Maier RV, Marzi I, Moore F, Piazzalunga D, Sakakushev B, Sartelli M, Scalea T, Stahel PF, Taviloglu K, Tugnoli G, Uraneus S, Velmahos GC, Wani I, Weber DG, Viale P, Sugrue M, Ivatury R, Kluger Y, Gurusamy KS, Moore EE (2016) 2016 WSES guidelines on acute calculous cholecystitis. World J Emerg Surg 11:25CrossRef

18.

Liang B, Dai M, Zou ZH (2016) Safety and efficacy of antibiotic prophylaxis in patients undergoing elective laparoscopic cholecystectomy: a systematic review and meta-analysis. J Gastroenterol Hepatol 31(5):921–928CrossRef

19.

Bari H, Khan MR, Shariff AH (2017) Antibiotics in acute calculous cholecystitis - do Tokyo guidelines influence the surgeons' practices? J Pak Med Assoc 67(5):670–676PubMed

20.

Probst P, Zaschke S, Heger P, Harnoss JC, Hüttner FJ, Mihaljevic AL, Knebel P, Diener MK (2019) Evidence-based recommendations for blinding in surgical trials. Langenbeck's Arch Surg 404(3):273–284CrossRef

21.

Loozen CS, Kortram K, Kornmann VN, van Ramshorst B, Vlaminckx B, Knibbe CA et al (2017) Randomized clinical trial of extended versus single-dose perioperative antibiotic prophylaxis for acute calculous cholecystitis. Br J Surg 104(2):e151–e1e7CrossRef

22.

Kim EY, Yoon YC, Choi HJ, Kim KH, Park JH, Hong TH (2017) Is there a real role of postoperative antibiotic administration for mild-moderate acute cholecystitis? A prospective randomized controlled trial. J Hepatobiliary Pancreat Sci 24(10):550–558CrossRef

23.

de Santibanes M, Glinka J, Pelegrini P, Alvarez FA, Elizondo C, Giunta D et al (2018) Extended antibiotic therapy versus placebo after laparoscopic cholecystectomy for mild and moderate acute calculous cholecystitis: a randomized double-blind clinical trial. Surgery.

24.

Reuken PA, Torres D, Baier M, Loffler B, Lubbert C, Lippmann N et al (2017) Risk Factors for multi-drug resistant pathogens and failure of empiric first-line therapy in acute cholangitis. PLoS One 12(1):e0169900CrossRef

25.

Kwon JS, Han J, Kim TW, Oh JH, Kwon HH, Jung JT et al (2014) Changes in causative pathogens of acute cholangitis and their antimicrobial susceptibility over a period of 6 years. The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi 63(5):299–307CrossRef

26.

European Centre for Disease Prevention and Control. Antimicrobial survillance in Europe 2014. Annual Report of the European Antimicrobial Resistance Survillance Network (EARS-Net) 2015

Title: Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial
Authors: Gona Jaafar
Gabriel Sandblom
Lars Lundell
Folke Hammarqvist
Publication date: 01-12-2020
Publisher: Springer Berlin Heidelberg
Keywords: Cholecystitis
Antibiotic
Cholecystectomy
Piperacillin
Published in: Langenbeck's Archives of Surgery / Issue 8/2020
Print ISSN: 1435-2443
Electronic ISSN: 1435-2451
DOI: https://doi.org/10.1007/s00423-020-01977-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

Please log in to get access to this content

Other articles of this Issue 8/2020

Irrigation and passive drainage of pancreatic stump after distal pancreatectomy in high-risk patients: an innovative approach to reduce pancreatic fistula

Is an enhanced recovery program (ERP) after rectal surgery as feasible as after colonic surgery? A multicentre Francophone study of 870 rectal resections

Outcomes of esophageal bypass surgery and self-expanding metallic stent insertion in esophageal cancer: reevaluation of bypass surgery as an alternative treatment

Disinfection with single or double usage of new antiseptic olanexidine gluconate in general surgery: a randomized study

Robotic resection for benign primary retroperitoneal tumors via the transperitoneal approach

Loop ileostomy versus loop colostomy as temporary deviation after anterior resection for rectal cancer