Abstract
Background
Laparoscopic cholecystectomy (LC) is the most common surgery done in general surgical practice worldwide. Despite clear guidelines recommending against the routine use of antibiotic prophylaxis (ABP) for elective LC by professional entities such as the Scottish Intercollegiate Guidelines Network (SIGN), Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) etc., most surgeons are not convinced about omitting ABP in low-risk LC. Thus, this study aimed at capturing the practice of administering ABP in elective LC among surgeons of Armed Forces Medical Services (AFMS).
Methods
This was a survey based on an electronic, cross-sectional, self-completion questionnaire that was designed and disseminated amongst 184 surgeons of the AFMS, online, and the data was collated centrally.
Results
64% of surgeons completed the survey. The majority (85%) of surgeons used ABP routinely in elective LC. In the univariate analysis, only the number of years of surgical experience and the total number of LC done in an entire career, and in the multivariate analysis age group of the surgeon, surgical experience and designation were significant factors for avoiding routine ABP in elective LC. Amongst the surgeons administering ABP, only 30% administered a single dose, 73% chose a single agent and Cefotaxime (57%) was the commonest antibiotic used.
Conclusion
This study found that there is a high prevalence of use of antibiotic prophylaxis in elective laparoscopic cholecystectomy amongst the surgeons of the AFMS. There was a wide variation in terms of choice of antibiotics, administering single or multiple doses and as a single agent or combination therapy.
Registered with clinical trials registry of India
CTRI/2019/03/018092.
Keywords: Cholecystectomy, Laparoscopic, Clean contaminated, Antibiotic prophylaxis, Survey, Port site infection, Surgical site infection
Introduction
It is an endeavor of every surgeon to see that their patients make an uneventful recovery from the surgery they have performed. Surgical site infection (SSI) is a major cause of morbidity in surgical patients that adversely impacts the quality of life and adds to the cost of patient care.1 Guidelines exist for interventions to minimize SSIs; and one such intervention is antibiotic prophylaxis (ABP), which is deemed mandatory for clean-contaminated, contaminated, and some specific categories of clean surgeries.2 However, inappropriate use of antibiotics brings with it problems like increased health-care costs, antibiotic resistance, allergic and anaphylactic reactions, side-effects and antibiotic-induced diarrhea.3
Gallstone disease is a common surgical condition, and cholecystectomy is the most common surgery done in general surgical practice world-wide.4 Designated as a clean-contaminated surgery, surgeons routinely gave ABP especially in the era of open cholecystectomy. Henry et al have reported an SSI rate of 2% in the open cholecystectomy era.5 Currently, laparoscopic cholecystectomy (LC) is the gold standard for gall stone disease. Some advantages of a laparoscopic approach are small incisions, minimal tissue manipulation and exposure to the environment, shorter duration of surgery and hospital stay thus resulting in lesser SSI. Therefore, the indiscriminate practice of ABP in all cases of elective LC has been questioned. In fact, there are clear guidelines from the Scottish Intercollegiate Guidelines Network (SIGN)6 and Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)7 that recommend ABP in only cases with risk factors.8,9
We observed that there was a disconnect between what the guidelines said and what the actual practice was. Further, there is at least one randomized trial from a tertiary center of Armed Forces Medical Services (AFMS) which has shown no benefit of routine ABP in LC.10 Despite this, we believe, most surgeons both in the civil and AFMS are not convinced about omitting ABP in low-risk LC. There are two studies from the west that have looked at the practice of ABP in LC but none from India.11,12 The aim of present study was to know the current practice of ABP in elective LC among surgeons of the AFMS with a primary objective to know the prevalence of ABP in elective LC and a secondary objective to identify the pattern of antibiotic usage for the ABP.
Material and methods
Conduct of study
We conducted the study in accordance with the World Medical Association Declaration of Helsinki and the American Association for Public Opinion Research best practices for survey research. We took institutional ethical committee clearance, and we registered the study with the Clinical Trials Registry of India.
Development of survey questionnaire
This was a survey based on an electronic, cross-sectional, self-completion questionnaire designed on Google Docs. We kept the questionnaire short to enhance the response rates and its quality. This comprised 15 close-ended and open-ended questions, along with a box for answers other than those offered in the close-ended questions (see Supplementary material). We framed the questions after going through guidelines and the published literature. We took the pilot work by sending the questionnaire to 10 surgeons to assess the quality of the questionnaire for clarity and to weed out any ambiguity before we finalized the questionnaire. The target population for the survey was a cluster sample 184 surgeons amongst all surgeons of the AFMS.
Dissemination of survey and data collection
We sent the questionnaire over the electronic media to surgeons of the AFMS with a single reminder at the end of one week. We offered no incentive except for the fact that they would take part in a survey that could help change practice. We maintained confidentiality of the participants. We centrally collated the received responses and analyzed the data.
Statistical analysis
We tabulated the collected data and analyzed it in MS Excel and IBM statistical package for social sciences (SPSS)-version 23. Chi-square test, Student’s t-test for univariate analysis and Fisher’s exact test for multivariate analysis were used to determine the p-value for the test of significance under a 95% confidence interval. P-value < 0.05 was considered statistically significant.
Results
We sent the questionnaire to 184 surgeons, and 117 (63.6%) responded. The margin of error was 5.48% assuming a confidence level of 95%. The cumulative experience amounted to approximately 43,400 LC procedures done over 1118 surgeon-years. Table 1 gives the characteristics of the participants.
Table 1.
Participants related variables.
| Variable | Groups | n (%) |
|---|---|---|
| Age group (Years) | 30–40 40–50 >50 |
64 (54.7) 35 (29.9) 18 (15.4) |
| Surgical experience (Years) | <5 5–10 10–15 15–20 >20 |
48 (41) 17 (14.5) 17 (14.5) 17 (14.5) 18 (15.5) |
| Designation | Graded Specialist Classified specialist Senior advisor Consultant Senior consultant Other |
52 (44.5) 30 (25.6) 22 (18.8) 2 (1.7) 5 (4.3) 6 (5.1) |
| Specialty | General Surgeon GI Surgeon Other |
71 (60.7) 30 (25.6) 16 (13.7) |
| No. of LC done per year | <50 50–100 100–150 150–200 >200 |
57 (48.7) 31 (26.5) 18 (15.4) 9 (7.7) 2 (1.7) |
| No. of LC done in entire career | <100 100–500 500–1000 >1000 |
48 (41.1) 30 (25.6) 28 (23.9) 11 (9.4) |
The prevalence of ABP in elective LC was 84.6% (99 out of 117 surgeons) (Fig. 1). Some 63 (63.6%) of this subgroup of surgeons prescribed three doses, while 30 (30.3%) of them administered a single dose, and 06 (6.1%) administered more than three doses (Fig. 2). Further 17 (17.2%) surgeons prescribed oral antibiotics on discharge.
Fig. 1.
The proportion of Surgeons routinely using prophylactic antibiotics in elective laparoscopic cholecystectomy.
Fig. 2.
Summary of the survey.
Out of these, 27 (27.3%) surgeons used a combination (either with amikacin or metronidazole) while the rest preferred a single agent. Two respondents preferred a combination of three antibiotics (cefotaxime, amikacin, and metronidazole). Cefotaxime (56.6%) was the most preferred agent, followed by ceftriaxone (24.2%) and fluoroquinolones (16.2%).
Of all the factors studied, in the univariate analysis, the number of years of surgical experience and the total number of LC done in the entire career was significant for avoiding routine prophylactic antibiotics in elective LC (Table 2). In the multivariate analysis, the age of the surgeon, and surgical experience and designation were significant factors for not using prophylactic antibiotics routinely (Table 3).
Table 2.
Univariate analysis of various factors influencing prophylactic antibiotic use.
| Factors | Groups | Frequency (%) | 95% confidence interval | t-test | p-value |
|---|---|---|---|---|---|
| Age group | 30–40 40–50 >50 |
64 (54.7) 35 (29.9) 18 (15.4) |
46.2–64.1 21.4–37.6 9.4–22.2 |
2.904 | 0.102 |
| Surgical experience | <5 5–10 10–15 15–20 >20 |
48 (41.0) 17 (14.5) 17 (14.5) 17 (14.5) 18 (15.4) |
32.5–50.4 8.5–21.5 8.5–21.4 8.5–21.4 9.4–22.2 |
3.803 | 0.019∗ |
| Designation | Graded Specialist Classified Specialist Senior Advisor Consultant Senior Consultant Other |
52 (44.4) 30 (25.6) 22 (18.8) 2 (1.7) 5 (4.3) 6 (5.1) |
35.9–53.8 17.9–33.3 12.0–25.6 0–4.3 0.9–8.5 1.7–9.4 |
2.468 | 0.056 |
| Speciality | General Surgeon GI Surgeon Other |
71 (60.7) 30 (25.6) 16 (13.7) |
51.3–69.2 17.9–34.2 7.7–20.5 |
2.226 | 0.142 |
| LCs done in one year | <50 50–100 100–500 500–1000 >1000 |
57 (48.7) 31 (26.5) 18 (15.4) 9 (7.7) 2 (1.7) |
39.3–58.1 17.9–35.0 9.4–22.2 2.6–12.8 0–4.3 |
2.413 | 0.073 |
| LCs done in entire surgical career | <100 100–500 500–1000 >1000 |
48 (4.0) 30 (25.6) 28 (23.9) 11 (9.4) |
32.5–50.4 17.1–33.3 16.2–31.6 4.3–15.4 |
3.866 | 0.031∗ |
Table 3.
Multivariate analysis of various factors influencing prophylactic antibiotic use.
| Factors | Standardized Coefficients |
df | F | p-value | |
|---|---|---|---|---|---|
| Beta | Bootstrap (1000) Estimate of Std. Error | ||||
| Age Group | −0.403 | 0.103 | 3 | 15.364 | 0.000 |
| Surgical Experience | −0.228 | 0.128 | 2 | 3.200 | 0.045 |
| Designation | −0.288 | 0.114 | 2 | 6.363 | 0.002 |
| Specialty | −0.283 | 0.194 | 1 | 2.130 | 0.148 |
| LCs done in one year | −0.182 | 0.154 | 2 | 1.409 | 0.249 |
| LCs done in entire surgical career | 0.156 | 0.191 | 3 | 0.669 | 0.573 |
Fig. 3 gives the breakup of the factors that would prompt surgeons, not routinely using prophylactic antibiotics, to use antibiotics. Of these 18 surgeons, 04 believed the rates of SSIs were lesser with the switching over to selective use of antibiotics policy while the remaining 14 thought the rates were the same as before.
Fig. 3.
Factors influencing administration of antibiotics among surgeons who did not routinely administer prophylactic antibiotics.
Discussion
This is the first study from India that has attempted to capture the practice of ABP in LC and surveyed a specific subgroup of surgeons practicing in the AFMS. To the best of our knowledge, there are only two studies that have attempted to address this issue, and both have come from the United Kingdom (UK).
The highlight of our study was that our survey could achieve a response rate of 64%. The two studies from the UK reported a response rate of 25% and 45% only.11,12 The key result that emanates from the present study is that an overwhelming 85% of surgeons routinely administer ABP in all cases of LC, even in the absence of any of the risk factors. This is in stark contrast with the results of the two studies which reported ABP rates of 36% and 31%.11,12 The Scottish Intercollegiate Guidelines Network (SIGN) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines have explicitly stated that ABP in LC is given only in cases with high-risk factors for SSI. These risk factors include age >60 years, diabetes, acute biliary colic within 30 days of operation, and those with jaundice, acute cholecystitis or cholangitis (SAGES; Level 1 evidence, Grade A recommendation)6 and intraoperative cholangiogram, bile spillage, conversion to laparotomy, acute cholecystitis/pancreatitis, jaundice, pregnancy, immunosuppression, insertion of prosthetic device (SIGN; Level 1+ evidence, Grade A recommendation).5
Of the seven meta-analyses to date on this issue, six have concluded that there is no clear benefit of ABP in elective LC.13, 14, 15, 16, 17, 18 The only study to come out in favor of ABP has been criticized for the exclusion of some studies.19 Interestingly, this meta-analysis, in a subgroup analysis, showed that two doses of antibiotics and 3–10 doses of antibiotic significantly reduced the incidence of surgical site infections while a single dose of antibiotic administration did not.
Our study also looked at the pattern of antibiotic use. Over 80% of the surgeons preferred a third-generation cephalosporin. Further, 27% of surgeons would exhibit a combination of antibiotics, and 17% would prescribe oral antibiotics on discharge. Also, of concern was the fact that 70% of the surgeons would administer more than one dose of antibiotics. Most guidelines recommend a first-generation cephalosporin like cephazolin as a single dose prior to incision.1,2 However, a meta-analysis did not find any particular antibiotic to be superior; be it a first, second, third-generation cephalosporin or amoxicillin-sulbactam or fluoroquinolones.18 In our study, we found that most of the surgeons recommending ABP were young by age and experience. This highlights the need to teach the correct guideline of ABP in the training phase of general surgery.
Participants had an option to provide additional free-text answers at the end of the questionnaire to have their views, and 29 participants used this option. Two surgeons remarked that they just followed the institutional antibiotic policy which mandated the use of ABP and one said that the choice of antibiotic depended on availability. Another participant commented that as surgeons, we are always mentored by senior surgeons and that we follow a lot of what we learn during training. Though he knew that level 1 evidence has shown no benefit of ABP in elective, low-risk LC, he went by what was the practice during his training. Another surgeon said that though he believed that ABP was not required, he was not too sure of other factors in the operation theater (OT), like sterility of lap instruments and operating room, and hence gave ABP. Bile spill is not an uncommon occurrence during LC. Seven surgeons remarked that they would give extended doses of antibiotics and/or add metronidazole in this scenario.
In 2010, Gaur et al published a randomized trial from a tertiary care center of AFMS which concluded that ABP was not needed in LC.10 Since then, at the same center, between successive GI surgeons, we have done over 1000 LCs. Our policy is to not to give ABP in elective LC routinely. Unlike the SAGES recommendation, advanced age, recent biliary colic, and well-controlled diabetes were not the indications for us to give prophylactic antibiotics. And our SSI rates in LC are less than 0.5% which compares favorably with world literature20 and are no different from the results of the general surgery counterparts at our center who routinely administer ABP in all cases of LC.
We would consider ABP in the following circumstances: Common bile duct (CBD) instrumentation, immunosuppression, recent acute cholecystitis, cholangitis or perforation during an empyema or conversion to open surgery. We prefer to administer a single dose of a third-generation cephalosporin at least 30 min prior to skin incision.
In most hospitals of AFMS, LC is the commonest surgery being done. Thus, judicious use of ABP will lead to a formidable reduction in health-care costs along with a considerable reduction in other negative consequences of inappropriate antibiotic use.
The strength of this study is in including heterogenous participants across the country from all levels of health care system which included 65 hospitals thus representing an unbiased, true picture of ABP practice in LC. The first limitation of this study is that it did not take into account the myriad of OT practices across the spectrum of the participating hospitals which include methods of sterilization of laparoscopic instruments and operating rooms, and their preoperative protocols including skin preparation. All these factors by itself or in combination can affect SSI following LC. Second, this study is survey-based and hence depended on the surgeon's memory. Consequently, it is liable to be imprecise in the collection of data for some variables.
In conclusion, this study found that there is a high prevalence of use of antibiotic prophylaxis in elective LC amongst the surgeons of the AFMS. There was a wide variation in terms of choice of antibiotics, administering single or multiple doses and as a single agent or combination therapy. The age group of the surgeon, surgical experience and designation were significant factors for avoiding routine ABP in elective LC. Implementation of a central AFMS policy keeping the current evidence in mind by all the AFMS surgeons will be beneficial to both the patient and the organization.
Disclosure of competing interest
The authors have none to declare.
Acknowledgments
Ms Anuradha Hazarika Medhi, Statistician, Department of Preventive and Social Medicine, Jorhat Medical College, Assam for the statistical analysis.
Footnotes
Supplementary data to this article can be found online at https://doi.org/10.1016/j.mjafi.2020.12.014.
Appendix A. Supplementary data
The following is the Supplementary data to this article:
Survey questionnaire.
References
- 1.Woods R.K., Dellinger E.P. Current guidelines for antibiotic prophylaxis of surgical wounds. Am Fam Physician. 1998;57(11):2731–2740. [PubMed] [Google Scholar]
- 2.Berríos-Torres S.I., Umscheid C.A., Bratzler D.W., et al. Healthcare infection control practices advisory committee. Centers for disease control and prevention guideline for the prevention of surgical site infection. JAMA Surg. 2017;152(8):784–791. doi: 10.1001/jamasurg.2017.0904. [DOI] [PubMed] [Google Scholar]
- 3.Cosgrove S.E. The relationship between antimicrobial resistance and patient outcomes: mortality, length of hospital stay, and health care costs. Clin Infect Dis. 2006;42(suppl 2):S82–S89. doi: 10.1086/499406. [DOI] [PubMed] [Google Scholar]
- 4.Decker M.R., Dodgion C.M., Kwok A.C., et al. Specialization and the current practices of general surgeons. J Am Coll Surg. 2014;218(1):8–15. doi: 10.1016/j.jamcollsurg.2013.08.016. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Henry M.L., Carey L.C. Complications of cholecystectomy. Surg Clin North Am. 1983;63(6):1191–1204. doi: 10.1016/s0039-6109(16)43182-8. [DOI] [PubMed] [Google Scholar]
- 6.Scottish Intercollegiate Guidelines Network . SIGN; Edinburgh: 2014. Antibiotic Prophylaxis in Surgery: A National Clinical Guideline (SIGN Guideline 104) [Google Scholar]
- 7.Society of American Gastrointestinal and Endoscopic Surgeons . SAGES; Los Angeles, CA: 2010. Guidelines for the Clinical Application of Laparoscopic Biliary Tract Surgery.http://www.sages.org/publications/guidelines/guidelines-for-theclinical-application-of-laparoscopic-biliary-tract-surgery (cited October 2019) [Google Scholar]
- 8.Choudhary A., Bechtold M.L., Puli S.R., Othman M.O., Roy P.K. Role of prophylactic antibiotics in laparoscopic cholecystectomy: a meta-analysis. J Gastrointest Surg. 2008;12:1847–1853. doi: 10.1007/s11605-008-0681-x. discussion 53. [DOI] [PubMed] [Google Scholar]
- 9.Pasquali S., Boal M., Griffiths E.A., et al. Meta-analysis of perioperative antibiotics in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2016;103(1):27–34. doi: 10.1002/bjs.9904. [DOI] [PubMed] [Google Scholar]
- 10.Gaur A., Pujahari A.K. Role of prophylactic antibiotics in laparoscopic cholecystectomy. Med J Armed Forces India. 2010;66(3):228–230. doi: 10.1016/S0377-1237(10)80043-7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Macano C., Griffiths E.A., Vohra R.S. Current practice of antibiotic prophylaxis during elective laparoscopic cholecystectomy. Ann R Coll Surg Engl. 2017;99(3):216–217. doi: 10.1308/rcsann.2017.0001. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Graham H.E., Vasireddy A., Nehra D. A national audit of antibiotic prophylaxis in elective laparoscopic cholecystectomy. Ann R Coll Surg Engl. 2014;96(5):377–380. doi: 10.1308/003588414X13946184900688. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Sanabria A., Dominguez L.C., Valdivieso E., Gomez G. Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010;12:CD005265. doi: 10.1002/14651858.CD005265.pub2. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Catarci M., Mancini S., Gentileschi P., Camplone C., Sileri P., Grassi G.B. Antibiotic prophylaxis in elective laparoscopic cholecystectomy: lack of need or lack of evidence? Surg Endosc Other Interv Tech. 2004;18(4):638–641. doi: 10.1007/s00464-003-9090-0. [DOI] [PubMed] [Google Scholar]
- 15.Choudhary A., Bechtold M.L., Puli S.R., Othman M.O., Roy P.K. Role of prophylactic antibiotics in laparoscopic cholecystectomy: a meta-analysis. J Gastrointest Surg. 2008;12(11):1847–1853. doi: 10.1007/s11605-008-0681-x. [DOI] [PubMed] [Google Scholar]
- 16.Zhou H., Zhang J., Wang Q., Hu Z. Meta-analysis: antibiotic prophylaxis in elective laparoscopic cholecystectomy. Aliment Pharmacol Ther. 2009;29(10):1086–1095. doi: 10.1111/j.1365-2036.2009.03977.x. [DOI] [PubMed] [Google Scholar]
- 17.Yan R.-C., Shen S.-Q., Chen Z.-B., Lin F.-S., Riley J. The role of prophylactic antibiotics in laparoscopic cholecystectomy in preventing postoperative infection: a meta-analysis. J Laparoendosc Adv Surg Tech A. 2011;21(4):301–306. doi: 10.1089/lap.2010.0436. [DOI] [PubMed] [Google Scholar]
- 18.Gomez-Ospina J.C., Zapata-Copete J.A., Bejarano M., Garcia-Perdomo H.A. Antibiotic prophylaxis in elective laparoscopic cholecystectomy: a systematic review and Network meta-analysis. J Gastrointest Surg. 2018;22(7):1193–1203. doi: 10.1007/s11605-018-3739-4. [DOI] [PubMed] [Google Scholar]
- 19.Liang B., Dai M., Zou Z. Safety and efficacy of antibiotic prophylaxis in patients undergoing elective laparoscopic cholecystectomy: a systematic review and meta-analysis. J Gastroenterol Hepatol. 2016;31:921–928. doi: 10.1111/jgh.13246. [DOI] [PubMed] [Google Scholar]
- 20.Warren D.K., Nickel K.B., Wallace A.E., et al. Risk factors for surgical site infection after cholecystectomy. Open Forum Infect Dis. 2017;4(2):ofx036. doi: 10.1093/ofid/ofx036. [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Survey questionnaire.