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Research Article | Volume 15 Issue 2 (Feb, 2025) | Pages 1 - 5
A Comparative Observational Study on The Incidence of Surgical Site of Infections in Low-Risk Patients, Undergoing the Elective Laparoscopic Cholecystectomy with And Without Prophylactic Antibiotics in A Rural Tertiary Health Facility
 ,
 ,
1
Assistant Professor, Department of General Surgery, Veerangana Avantibai Lodhi Autonomous State Medical College, Etah, Uttar Pradesh, India
2
Assistant Professor, Department of General Surgery, Autonomous State Medical College, Lalitpur, Uttar Pradesh, Inida
3
Professor J Grade, Department of General Surgery, UPUMS, Etawah, India
Under a Creative Commons license
Open Access
Received
Dec. 29, 2024
Revised
Jan. 3, 2025
Accepted
Jan. 20, 2021
Published
Feb. 3, 2025
Abstract

Laparoscopic Cholecystectomy is one of the widely performed elective surgeries worldwide and is the gold standard method for patients with symptomatic gallstones. It was a common practice earlier, to use prophylactic antibiotics before an operative procedure; but recent studies show evidence againsttheuseofprophylacticantibioticsinlow-riskpatientsundergoingelective laparoscopic cholecystectomy. In our study we included 200 patients diagnosed with symptomatic cholelithiasis and divided them into 2 groups of 100 patients each. All were planned for elective laparoscopic cholecystectomy, in which, group (A) underwent surgery without any prophylactic antibiotics and the other group (B) got the routine antibiotic prophylaxis preoperatively. At 95% confidence level, there is no significant difference in the fever, port site infection and raised TLC (Leucocytosis) during hospital stay, at the time of discharge and on1-weekfollow-upof the patients in both the study groups. We concluded that there is no need for routine antibiotic prophylaxis in patients undergoing an elective uncomplicated laparoscopic cholecystectomy for symptomatic gallstone disease.

Keywords
INTRODUCTION

Laparoscopic cholecystectomy has become the gold standard technique for management of symptomatic gallstones. Prophylactic antibiotics are used in elective surgery by majority of surgeons, and their role in biliary tract surgery has been well established for a sub population of high-risk patients. This consensus has been derived from multiple studies involving biliary tract surgery before and in the era of laparoscopic cholecystectomy. Surgical site infections (SSIs), a significant post-operative complication, can lead to considerable patient morbidity and mortality.[1]  Preventing postoperative infection is a challenging factorin improving the surgical outcomes. One of the many collective approach for preventing SSI is the administration of prophylactic antibiotics.[2,3]

 

The use of prophylactic antibiotics in preventing SSI sis still controversialinelectiveLC, which has a low risk for infectious complications. Laparoscopic cholecystectomy uses smaller incision and trocars that lessen the contamination and exposure of wound, resulting in less infection. However, the antibiotic prophylaxis  is still widely practiced, like in our institute, a continuation of the era of open surgery. Recent studies reveal no advantage of routine use of antibiotic, and there are several trials/studies against it. Besides their cost, irrational antibiotic use increases the emergence of multidrug resistance.[4]

MATERIALS AND METHODS

This study was conducted over a period of 17 months, from November 2019 to March 2021, in the department of General Surgery at a tertiary level teaching hospital.Two hundred in-patients (Male & Female included) admitted in the surgical wards were included in this study. All patients had symptomatic gallstones without any prior chronic illness or co morbidities, and all were planned for elective laparoscopic cholecystectomy. The patients were interviewed for detailed clinical history. All the patients were examined and underwent complete blood count, Random blood sugar, blood urea nitrogen and serum creatinine, liver function test, electrocardiogram, chestx-ray (PA view), and urine for RE, ME, and C/S. These patients were randomly divided into 2 groups preoperatively– One group of 100 patients (A) underwent surgery without any prophylactic antibiotics and the other group of 100 patients (B) got the routine antibiotic prophylaxis preoperatively.

 

All patients were advised nil by mouth overnight prior to surgery and were administered a proton pump inhibitor (Pantoprazole 40 mg IV) and an anxiolytic (Alprazolam 0.5 mg PO) the night before the day of surgery. Antiseptic skin shaving was done in the morning of the day of operation. All patients were prepared with chlorhexidine gluconate scrub from mid-chest to mid-thigh including the umbilicus on the day of operation just prior to skin incision. No prophylactic antibiotics were administered for Group-A patients whereas a routine prophylactic broad-spectrum antibiotic (Ceftriaxone 1 gram IV) was given to patients in Group-B.

 

All the patients underwent a classical 4-port Laparoscopic cholecystectomy. Intra-operatively, the gallbladder was removed through the epigastric port without using any extraction bag. During the postoperative hospital day, patients' wounds were inspected, and specific significant symptoms of wound site infections were noted. Related blood investigations were done, and the results were analyzed. Port-site infection, fever and raised TLC are considered and are analyzed as follows: during the post operative hospital stay, on discharge and on 1-week follow-up.

RESULTS

A total of 200 patients (100 patients in each group) were included in the study. Of the 100 patients in Group-A, 14 were males (14% of the patients) and 86 were females (86% of the patients) where as in Group-B, 17 were males (17% of the patients) and 83 were females (83% of the patients).

 

In Group-A, 7 patients were within 16–20 years, 45patients were within 21–30 years, 33 patients were within 31–40 years, 15 patients were within 41–50 years. In Group-B, 4 patients were within 16–20 years, 46 patients were within 21–30 years, 38 patients were within 31–40 years, 12 patients were within 41–50 years. In both groups, majority of the patients were in the 21–30 year age group.

 

TABLE–1(Frequency distribution of patients according to gender)

Gender

NO.OF PATIENTS

(A) WITHOUT

PROPHYLAXIS

(B)WITH

PROPHYLAXIS

MALE

14 (14%)

17(17%)

FEMALE

86 (86%)

83(83%)

TOTAL

100

100

 

 

TABLE- 2 (Number of patients in each age group)

AGEGROUP

NO.OF PATIENTS

(A) WITHOUT

PROPHYLAXIS

(B) WITH

PROPHYLAXIS

16 -20 years

07 (7%)

04(4%)

21 -30 years

45 (45%)

46(46%)

31 -40 years

33 (33%)

38(38%)

41 -50 years

15 (15%)

12(12%)

TOTAL

100

100

 

Post operatively, during hospital stay, post-operative port site infection occurred in four cases of Group-A (4%) and three cases of Group-B (3%). All these infections were seen in the gallbladder extraction port (epigastric port). Six patients (6%) from Group-A and Seven patients (7%) from Group-B developed fever in the post-operative period. Five patients (5%) in Group-A and three patients in Group-B had elevated TLC post-operatively.

 

At the time of discharge, port site infection was seen in three cases (3%) each in both Group A and B. Only one patient (1%) from Group-A had a history of fever episode whereas no patients from group-B had history of febrile episode on discharge. Only one patient (1%) had elevated TLC in group- A whereas two patients (2%) had an elevated TLC from Group-B.

 

On 1-week post-operative follow-up, port site infection was seen in six patients (6%) of group-A and five patients (5%) of group-B. Two patients (2%) from group-A and one patient (1%) from group-B had history of fever after discharge. There were four patients (4%) each in group-A and B with elevated TLC on 1-week follow-up.

 

TABLE- 3 (Comparison of clinical profile between two study groups)

S. No.

Variable

Subgroup

WITH ANTIBIOTIC

WITHOUT ANTIBIOTIC

P VALUE

1

Fever in the hospital

Present

6

8

p=0.58

Absent

94

92

2

Fever on Discharge

Present

0

1

p=0.32

Absent

100

99

3

Feveron1-week follow-up

Present

1

2

p=0.56

Absent

99

98

4

Port site infection in hospital

Present

3

5

p=0.47

Absent

97

95

5

Port site infection on discharge

Present

3

6

p=0.31

Absent

97

94

6

Port site infection

on1-weekfollow- up

Present

5

6

p=0.76

Absent

95

94

7

Raised TLC in the hospital

Present

3

5

p=0.47

Absent

97

95

8

Raised TLC on discharge

Present

1

3

p=0.312

Absent

99

97

9

Raised TLC on 1- week follow-up

Present

4

4

p=1

Absent

96

96

 

At 95% confidence level, there is no significant difference in the fever, port site infection and raised TLC (Leucocytosis) during hospital stay, at the time of discharge and on1-week follow-up of the patients in both the study groups.This is suggestive of the fact that there is no need for prophylactic antibiotic administration preoperatively in patients with low-risk profile undergoing elective laparoscopic cholecystectomy.

 

 

DISCUSSION

Laparoscopic surgery is a most significant advancement in the last two decades. It has been proved that laparoscopic surgery minimizes surgical trauma, shortens hospital stay, and minimizes use of analgesics, and increases early return to work [5–7] Elective Laparoscopic cholecystectomy carries a low risk of wound infection. Uses of prophylactic antibiotics are not justified in patients undergoing elective, uncomplicated laparoscopic cholecystectomy. Unjustified use of the antibiotics does pave way for the alarmingly increasing rates of antibiotic resistance in healthcare. As laparoscopic cholecystectomy is now the gold standard of management of patients with gallstones, evaluation of antibiotic prophylaxis and its indication for minimal invasive surgeries is warranted.

 

In a study by Illig K A et al One hundred twenty-eight patients were randomized to receive prophylactic antibiotics (PA group), 122 to receive none (NONE group; two patients in this group were actually given preoperative antibiotics). Only one major complication occurred (in a patient in the NONE group), an abscess in the presence of a bile leak, despite the administration of antibiotics when the leak was discovered several days before infectious problems arose. There were four minor problems: two lower urinary tract infections and one superficial wound infection in a NONE patient and one urinary tract infection in a PA patient (not significant); all were easily managed. The prophylactic antibiotics did not sterilize the bile, and infectious complications were not associated with weight, inflammation found at the time of operation, reported stone or bile spill age, or conversion to open operation. The study concluded that prophylactic antibiotics are not necessary for elective laparoscopic cholecystectomy in low-risk patients. [8]

 

KOC et al. observed 2.04% of infections in the antibiotic prophylaxis group (Gr. A, n=49) and 2.32% of infections in the non-antibiotic prophylaxis group (Gr. B, n=43) in their prospective double-blinded randomized study of over 92 patients undergoing elective laparoscopic cholecystectomy. [9]

 

In a meta-analysis by Abhishek Choudhary et al, Nine RCTs (N=1,437) met the inclusion criteria. No statistically significant reduction was noted for those receiving prophylactic antibiotics and those who did not for overall infectious complications (p=0.20), superficial wound infections (p=0.36), major infections (p=0.97), distant infections (p=0.28), or length of hospital stay (p=0.77). No statistically significant publication bias or heterogeneity was noted. The analysis found out that prophylactic antibiotics do not prevent infections in low-risk patients undergoing laparoscopic cholecystectomy. [10]

CONCLUSION

There is no need for routine antibiotic prophylaxis in patients undergoing an elective uncomplicated laparoscopic cholecystectomy for symptomatic gall stone disease. A routine preoperative antiseptic skin scrub may be an easy and cost-effective way to prevent postoperative wound infections in such low-risk profile patients, after an electively performed laparoscopic cholecystectomy.     

REFERENCES
  1. Reddick EJ, Olsen DO (1989) Laparoscopic laser cholecystectomy: a comparison with mini-lap cholecystectomy. Surg Endosc 3:131–3
  2. Keighley MRB, Drysdale RB, Quoraishi AH, Burdon DW, Alexander-Williams J. Antibiotics in biliary disease: the relative importanceofantibioticconcentrationinbileandserum.Gut1976;17: 495- 500.
  3. Keighley MR, Baddeley R, Burdon D, Edwards JAC, Quoraishi AH, Oates GD. A controlled trial of parenteral prophylactic gentamicin therapy in biliary surgery. Br J Surg 1975; 62: 275-9.
  4. Shah JN, Maharjan SB, Paudyal S. Routine use of antibiotic prophylaxis in low-risk laparoscopic cholecystectomy is unnecessary: a randomized clinical trial. Asian journal of surgery. 2012 Oct 1;35(4):136-9.
  5. Zucker KA, Baily W, Gadacz TR. Imbembo Al. Laparoscopic guided cholecystectomy. Am J Surg. 1991;161:36-44.
  6. Mealy K, Gallager H, Barry M, Lennon F, Traynor O, Hyland J (1992) Physiological and metabolic responses to open and laparoscopic cholecystectomy. Br J Surg 79:1061–4
  7. Fisher KS, Matteson KM, Hammer MD (1993) Laparoscopic cholecystectomy: the Springfield experience. Surg Laparosc Endosc 3:199–203
  8. Illig KA, Schmidt E, Cavanaugh J, Krusch D, Sax HC. Are prophylactic antibiotics required for elective laparoscopiccholecystectomy? Journal of the American college of Surgeons. 1997 Apr;184(4):353-6.
  9. Koc M, Zulfikaroglu B, Kece C, Ozalp N (2003) A prospective randomized study of prophylactic antibiotics in elective laparoscopic cholecystectomy. Surg Endosc 17:1716–8
  10. Choudhary A, Bechtold ML, Puli SR, Othman MO, Roy PK. Role of prophylactic antibiotics in laparoscopic cholecystectomy: ameta-analysis. Journal of Gastrointestinal Surgery. 2008 Nov 1;12(11):1847-53.
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