The Effect of Prophylactic Antibiotics on Post Laparoscopic Cholecystectomy Infectious Complications

A Double-Blinded Clinical Trial

Authors

  • Farhad Bagherian Assistant Professor, Clinical Research Development Center, Shahid Beheshti Hospital, Babol University of Medical Sciences, Babol, Iran

Keywords:

Antibiotic prophylaxis, Surgical wound infection, Laparoscopic cholecystectomy

Abstract

Background: Laparoscopic cholecystectomy (LC) is one of the most common surgeries in laparoscopic surgery. Although, it is believed that LC has low-risk for post-operative infectious complications, the use of a prophylactic antibiotic is still controversial in elective LC. 

Objective: To determine the impact of prophylactic antibiotics on postoperative infection complications in elective laparoscopic cholecystectomy.

Methods: In this double-blind, placebo-controlled, randomized, clinical trial, patients who were candidates for elective LC, from March 2012 to 2015, in four hospitals in Babol, Iran, were studied. Patients were allocated randomly to two groups, i.e., group C: Cefazolin (n = 182) and group P: placebo (n = 247). Group C received 1 g of Cefazolin 30 minutes before anesthesia and and then, six and 12 hours after anesthesia. Group P patients received 10 ml of isotonic sodium chloride solution. Age, gender, type of gallbladder diseases (stone, polyp, or hydrops), the length of post-operative hospitalization, frequency of gallbladder rupture, the duration of surgery, and the kinds of complications associated with infections were collected for each patient in the two groups. The data were analyzed by IBM-SPSS version 20, using the t-test and the chi-squared test, and a p-value < 0.05 was considered as significant.

Results: There were no significant differences between the two groups in terms of gender (C versus P: 18 (9.9%) male versus 22 (9%); p = 0.74), age (C versus P: 43.75 + 13.30 years versus 40.91 + 13.05; p = 0.20), and duration of surgery (C versus P: 34.97 ± 8.25 min versus 34.11 ± 8.39; p = 0.71). There were no significant differences between the two groups in the incidences of post-operative infection (C versus P: 3 (1.7%) versus 5 (2%); p = 0.99) and rupture of the gallbladder (C versus P: 14 (7.8%) versus 17 (6.8%); p = 0.85).  No other post-operative systemic infectious complications (e.g., sepsis, pneumonia, or urinary tract infection) were found in either group. 

Conclusion: For patients who underwent laparoscopic cholecystectomy (LC), prophylactic antibiotics had no important role in the prevention of infections; so these antibiotics apparently are not necessary in treatment, and they are not recommended for patients with laparoscopic cholecystectomy as low-risk selective antibiotics.

Trial registration: The trial was registered at the Iranian Clinical Trial Registry (http://www.irct.ir) with the IRCT identification number IRCT2013070413865N1. 

Funding: This research was supported financially by the Research Council of Babol University of Medical Sciences.

 

References

Shea JA, Berlin JA, Bachwich DR, Staroscik RN, Malet PF, McGuckin M, et al. Indications for and

outcomes of cholecystectomy: a comparison of the pre and post laparoscopiceras. Ann Surg. 1998; 227:

–50. doi: 10.1097/00000658-199803000-00005. PMID: 9527056, PMCID: PMC1191271.

McGuckin M, Shea JA, Schwartz JS. Infection and antimicrobial use in laparoscopic cholecystectomy.

Infect Control Hosp Epidemiol. 1999; 20: 624–6. doi: 10.1086/501685. PMID: 10501264.

Shea JA, Healey MJ, Berlin JA, Clarke JR, Malet PF, Staroscik RN, et al. Mortality and complications

associated with laparoscopic cholecystectomy. A meta-analysis. Ann Surg. 1996; 224: 609–20. doi:

1097/00000658-199611000-00005, PMID: 8916876, PMCID: PMC1235438.

Chang WT, Lee KT, Chuang SC, Wang SN, Kuo KK, Chen JS, et al. The impact of prophylactic antibiotics

on postoperative infection complication in elective laparoscopic cholecystectomy: a prospective

randomized study. Am J Surg. 2006; 191: 721–25. doi: 10.1016/j.amjsurg.2006.01.050. PMID: 16720138.

Koc M, Zulfikarog˘lu B, Kece C, Ozalp N. A prospective randomized study of prophylactic antibiotics in

elective laparoscopic cholecystectomy. Surg Endosc. 2003; 17: 1716 –18. doi: 10.1007/s00464-002-8866- y. PMID: 12802644.

Mahatharadol V. A reevaluation of antibiotic prophylaxis in laparoscopic cholecystectomy: a randomized

controlled trial. J Med Assoc Thai. 2001; 84: 105–8. PMID: 11281486.

Tocchi A, Lepre L, Costa G, Liotta G, Mazzoni G, Maggiolini F. The need for antibiotic prophylaxis in

elective laparoscopic cholecystectomy: a prospective randomized study. Arch Surg. 2000; 135: 67–70. doi:

1001/archsurg.135.1.67. PMID: 10636350.

Higgins A, London J, Charland S, Ratzer E, Clark J, Haun W, et al. Prophylactic antibiotics for elective

laparoscopic cholecystectomy: are they necessary? Arch Surg. 1999; 134: 611–4. doi:

1001/archsurg.134.6.611. PMID: 10367869.

Harling R, Moorjani N, Perry C, MacGowan AP, Thompson MH. A prospective, randomized trial of

prophylactic antibiotics versus bag extraction in the prophylaxis of wound infection in laparoscopic

cholecystectomy. Ann R Coll Surg Engl. 2000; 82: 408–10. PMID: 11103159, PMCID: PMC2503474.

Illig KA, Schmidt E, Cavanaugh J, Krusch D, Sax HC. Are prophylactic antibiotics required for elective

laparoscopic cholecystectomy? J Am Coll Surg. 1997; 184: 353–6. PMID: 9100679.

Dobay KJ, Freier DT, Albear P. The absent role of prophylactic antibiotics in low-risk patients undergoing

laparoscopic cholecystectomy. Am Surg. 1999; 65: 226–8. PMID: 10075297.

Kuthe SA, Kaman L, Verma GR, Singh R. Evaluation of the role of prophylactic antibiotics in elective

laparoscopic cholecystectomy: a prospective randomized trial. Trop Gastroenterol. 2006; 27: 54–7. PMID:

Lippert H, Gastinger J. Antimicrobial prophylaxis in laparoscopic and conventional cholecystectomy.

Conclusions of a large prospective multicenter quality assurance study in Germany. Chemotherapy. 1998;

: 355–63. doi: 10.1159/000007135. PMID: 9732152.

Uchiyama K, Kawai M, Onishi H, Tani M, Kinoshita H, Ueno M, et al. Preoperative antimicrobial

administration for prevention of postoperative infection in patients with laparoscopic cholecystectomy. Dig

Dis Sci. 2003; 48: 1955–9. doi: 10.1023/A:1026114203622. PMID: 14627340.

Shindholimath VV, Seenu V, Parshad R, Chaudhry R, Kumar A. Factors influencing wound infection

following laparoscopic cholecystectomy. Trop Gastroenterol. 2003; 24: 90 –2. PMID: 14603831.

Dervisoglou A, Tsiodras S, Kanellakopoulou K, Pinis S, Galanakis N, Pierakakis S, et al. The value of

chemoprophylaxis against Enterococcus species in elective cholecystectomy: a randomized study of

cefuroxime vs ampicillin-sulbactam. Arch Surg. 2006; 141: 1162–7. doi: 10.1001/archsurg.141.12.1162.

PMID: 17178957.

Sarli L, Pietra N, Costi R, Grattarola M. Gallbladder perforation during laparoscopic cholecystectomy.

World J Surg. 1999; 23: 1186–90. doi: 10.1007/s002689900644. PMID: 10501883.

Westphal JF, Brogard JM. Biliary tract infections: a guide to drug treatment. Drugs. 1999; 57(1): 81-91.

doi: 10.2165/00003495-199957010-00007.

Munro R, Sorrell TC. Biliary sepsis. Reviewing treatment options. Drugs. 1986; 31(5): 449-54. doi:

2165/00003495-198631050-00004. PMID: 3086069.

Wittmann DH, Condon RE. Prophylaxis of postoperative infections. Infection. 1991; 19(Suppl 6): S337–

doi: 10.1007/BF01715775. PMID: 1791080.

Kellum JM, Duma RJ, Gorbach SL, Sugerman HJ, Haynes BW Jr, Gervin A, et al. Single-dose antibiotic

prophylaxis for biliary surgery. Cefazolin vs moxalactam. Arch Surg. 1987; 122: 918–22. doi:

1001/archsurg.1987.01400200068012. PMID: 3115228.

Nichols RL. Preventing surgical site infections. Clin Med Res. 2004; 2: 115–8. doi: 10.3121/cmr.2.2.115.

PMID: 15931344, PMCID: PMC1069080.

Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site

infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol.

; 20: 250 –78. doi: 10.1086/501620. PMID: 10219875.

Catarci M, Mancini S, Gentileschi P, Camplone C, Sileri P, Grassi GB. Antibiotic prophylaxis in elective

laparoscopic cholecystectomy. Lack of need or lack of evidence? Surg Endosc. 2004; 18: 638–41. doi:

1007/s00464-003-9090-0. PMID: 14752639.

Den Hoed PT, Boelhouwer RU, Veen HF, Hop WC, Bruining HA. Infections and bacteriological data after

laparoscopic and open gallbladder surgery. J Hosp Infect. 1998; 39: 27–37. doi: 10.1016/S0195- 6701(98)90240-7.

Page CP, Bohnen JM, Fletcher JR, McManus AT, Solomkin JS, Wittmann DH. Antimicrobial prophylaxis

for surgical wounds. Guidelines for clinical care. Arch Surg. 1993; 128(1): 79-88. doi:

1001/archsurg.1993.01420130087014. PMID: 8418785.

Meijer WS, Schmitz PI, Jeekel J. Meta-analysis of randomized, controlled clinical trials of antibiotic

prophylaxis in biliary tract surgery. Br J Surg. 1990; 77(3): 283-90. doi: 10.1002/bjs.1800770315. PMID:

Yan RC, Shen SQ, Chen ZB, Lin FS, Riley J. The role of prophylactic antibiotics in laparoscopic

cholecystectomy in preventing postoperative infection: a meta- analysis. J Laparoendosc Adv Surg Tech A.

; 21(4): 301-6. doi: 10.1089/lap.2010.0436. PMID: 21443433.

Sanabria A, Dominguez LC, Valdivieso E, Gomez G. Antibiotic prophylaxis for Patients undergoing

elective laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010; (12): CD005265. doi:

1002/14651858.cd005265.pub2.

Mir MA, Malik UY, Wani H, Bali BS. Prevalence, pattern, sensitivity and resistance to antibiotics of

different bacteria isolated from port site infection in low risk patients after elective laparoscopic

cholecystectomy for symptomatic cholelithiasis at tertiary care hospital of Kashmir. Int Wound J. 2013;

(1): 110-3. doi: 10.1111/j.1742-481X.2012.00963.x. PMID: 22414004.

Hardy KJ, Miller H, Fletcher DR, Jones RM, Shulkes A, McNeil JJ. An evaluation of laparoscopic versus

open cholecystectomy. Med J Aust. 1994; 160(2): 58-62. PMID: 8309369.

Constant E, Janssen P, Nys JM, el Fouly PE, Lemmens F, Hachez L, et al. Prospective analysis of 192

consecutive cholecystectomies: a comparative study between laparoscopy and laparotomy. Acta Chir Belg.

; 95(6): 254-60. PMID: 8571715.

Berggren U, Gordh T, Grama D, Haglund U, Rastad J, Arvidsson D. Laparoscopic versus open

cholecystectomy: hospitalization, sick leave, analgesia and trauma responses. Br J Surg. 1994; 81(9): 1362- 5.

Uludag M, Yetkin G, Citgez B. The role of prophylactic antibiotics in elective laparoscopic

cholecystectomy. JSLS. 2009; 13(3): 337-41. PMID: 19793473, PMCID: PMC3015970.

Gold-Deutch R, Mashiach R, Boldur I, Ferszt M, Negri M, Halperin Z, et al. How does infected bile affect

the postoperative course of patients undergoing laparoscopic cholecystectomy? Am J Surg. 1996; 172:

– 4. doi: 10.1016/S0002-9610(96)00105-5. PMID: 8862082.

Colizza S, Rossi S, Picardi B, Carnuccio P, Pollicita S, Rodio F, et al. Surgical infections after laparoscopic

cholecystectomy: ceftriaxone vs ceftazidime antibiotic prophylaxis. A prospective study. Chir Ital. 2004;

: 397–402. PMID: 15287637.

Goldfaden A, Birkmeyer JD. Evidence-based practice in laparoscopic surgery: perioperative care. Surg

Innov. 2005; 12: 51–61. doi: 10.1177/155335060501200108. PMID: 15846447.

Suh SW, Park JM, Lee SE, Choi YS. Accidental gallbladder perforation during laparoscopic

cholecystectomy: does it have an effect on the clinical outcomes? J Laparoendosc Adv Surg Tech A. 2012;

(1):40-5. doi: 10.1089/lap.2011.0219. PMID: 22044492.

Emin Turk, Erdal Karagulle, Kivanc Serefhanoglu, Hale Turan, Gokhan Moray. Effect of Cefazolin

Prophylaxis on Postoperative Infectious Complication in Elective Laparoscopic Cholecystectomy: A

Prospective Randomized Study. Iranian red cresent med j. 2013; 15(7): 581-6. PMCID: PMC3871745.

Published

2022-03-07

Issue

Section

Articles