Role of prophylactic antibiotics for surgical site infection in patients operated for gall bladder removal laparoscopically

Phase 2

Not yet recruiting

• Conditions: Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (3) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (4) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (5) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (6) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,

• Registration Number: CTRI/2023/09/057772
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Title; Proposal Title: The effect of antibiotic prophylaxis on surgical site infection following elective laparoscopic cholecystectomy: A randomised clinical trial

Introduction

Laparoscopic cholecystectomy (LC) is the gold standard for treating symptomatic cholecystitis and is associated with fewer complications than its open counterpart. Surgical site infections (SSIs) postoperatively can lead to significant morbidity and mortality and are prevented in clean and clean-contaminated wounds by the use of antibiotic prophylaxis. However, routine use of antibiotics after clean LC has been equally questioned and supported. Although the Centers for Disease Control and Prevention recommends the administration of prophylactic antibiotics in clean-contaminated surgery such as LC to reduce surgical site infections (SSI), more recent meta-analyses have concluded that antibiotic prophylaxis is not warranted in low-risk patients undergoing LC. The current consensus seems to be to not use antibiotics in patients undergoing LC for low- or moderate-risk groups, owing to the modest risk of developing an SSI and costs to the healthcare system.

Justification for study

If a single intravenous dose of antibiotics (ceftriaxone) at the time of induction is found suitable in an Indian setting during elective LC, then routine continued administration of antibiotics can be abandoned as it contributes to adverse reactions, drug resistance, and unnecessary financial burden.



Aim(s) & objectives

The present study aims to test the need for postoperative antibiotics prophylaxis in elective laparoscopic cholecystectomy (LC) cases in a tertiary care setting.



Methodology

Study Method: Randomized Controlled Trial

Study Setting: Patients coming to the surgery outpatient department and surgical emergency will be

included in the study.

Study Participants: Adults patients (aged-18- 70 years) with Cholelithiasis and planned for laparoscopic

Cholecystectomy will be included in the study.

Inclusion Criteria:

1. Symptomatic Cholelithiasis

2. Any gender

3. 18- 60 years

4. ASA score I/II

Exclusion Criteria:

1. Comorbidities like DM, Malignancy, History of steroids, Immune suppression

2. Pregnancy

3. Laparoscopic Cholecystectomy converted to Open

Intervention: Single dose of Ceftriaxone 1 gm/ Cefazolin 2 mg 30 minutes before incision with no

antibiotics in the postoperative period.

Control: In addition to a single dose of Ceftriaxone 1 gm/ Cefazolin 2 mg 30 minutes before incision,

the control group will receive the same iv antibiotics with the twice daily dose for two days

postoperatively

Outcome: Surgical site infection on day-2 nd, 7th postoperative day.

Sample Size: Taking the incidence of surgical site infection among those with antibiotic prophylaxis

is 1.7% and for those without to be with the incidence of five times higher than those without. Thus

, the total sample size was 161, taking alpha error to be 5%, and power to be 80%. Taking

the nonresponse rate to 10%, the final sample size was 177 (rounded off to 180).

All Patients satisfying the inclusion criteria and exclusion criteria and consenting to the study will be

allocated to either the intervention Group-A (receiving the single dose of ceftriaxone or ceftazidime

1gm IV 30 minutes before incision with no antibiotics in the postoperative period) and Group-B

(receiving the single dose of ceftriaxone or ceftazidime 1gm IV 30 minutes before incision twice

daily for 2 days postoperatively).

Yes / No

e. Outcome measures

(a) Antibiotic use should be minimized to reduce or prevent bacterial resistance and the development

of opportunistic nosocomial infections and to avoid high costs.

(b). To evaluate the role of antibiotics in patients whose gallbladders would perforate during

laparoscopic cholecystectomy with biliary leakage on the incidence of surgical site infections (SSI).



Data Analysis & Plan

The proportion of patients showing SSI will be represented as a proportion with 95% CI. The data analysis will be done using the intention-treat method. The difference between the groups will be presented as a chi-square test.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-16
• Study Start: 2023-09-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Symptomatic Cholelithiasis 2.
• Any gender 3.
• 18- 60 years 4.
• ASA score I/II.

Exclusion Criteria

• Comorbidities like DM, Malignancy, History of steroids, Immune suppression 2.
• Pregnancy 3.
• Laparoscopic Cholecystectomy converted to Open.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(a) Antibiotic use should be minimized to reduce or prevent bacterial resistance & the development of opportunistic nosocomial infections and to avoid high costs.	sign of infection observed on | 2,7,15 days postoperatively and after one month.
(b). To evaluate the role of antibiotics in patients whose gallbladders would perforate during laparoscopic cholecystectomy with biliary leakage on the incidence of surgical site infections (SSI).	sign of infection observed on | 2,7,15 days postoperatively and after one month.

Secondary Outcome Measures

Name	Time	Method
To evaluate the role of antibiotics in patients whose gallbladders would perforate during	laparoscopic cholecystectomy with biliary leakage on the incidence of surgical site infections (SSI).

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Gorakhpur, UTTAR PRADESH, India

All India Institute of Medical Sciences

🇮🇳Gorakhpur, UTTAR PRADESH, India

Dr Dharmendra Kumar Pipal

Principal investigator

9602541730

dr.dharmendrapipal2007@gmail.com