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

The effect of antibiotic prophylaxis on surgical site infection following elective laparoscopic cholecystectomy: A randomised clinical trial - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057772

Enrollment

180

Registered

2023-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis Health Condition 2: K801- Calculus of gallbladder with othercholecystitis Health Condition 3: K801- Calculus of gallbladder with othercholecystitis Health Condition 4: K801- Calculus of gallbladder with othercholecystitis Health Condition 5: K801- Calculus of gallbladder with othercholecystitis Health Condition 6: K801- Calculus of gallbladder with othercholecystitis

Interventions

Intervention1: I.V. Antibiotics: No Antibiotics Intervention2: Single dose of antibiotic prior to surgery: A single dose of Ceftriaxone 1 gm/ Cefazolin 2 mg 30 minutes before incision with no antibiot

Eligibility

Inclusion criteria

Inclusion criteria: 1. Symptomatic Cholelithiasis 2. Any gender 3. 18- 60 years 4. ASA score I/II

Exclusion criteria

Exclusion criteria: 1. Comorbidities like DM, Malignancy, History of steroids, Immune suppression 2. Pregnancy 3. Laparoscopic Cholecystectomy converted to Open

Design outcomes

Primary

Measure	Time frame
(a) Antibiotic use should be minimized to reduce or prevent bacterial resistance & 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).Timepoint: sign of infection observed on 2,7,15 days postoperatively and after one month.	—

Measure

Time frame

(a) Antibiotic use should be minimized to reduce or prevent bacterial resistance & 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).Timepoint: sign of infection observed on 2,7,15 days postoperatively and after one month.

—

Secondary

Measure	Time frame
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).Timepoint: 1 YEAR	—

Countries

India

Contacts

Public ContactDharmendra Kumar Pipal

All India Institute of Medical Sciences

dr.dharmendrapipal2007@gmail.com09602541730

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026