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CTRI Number  CTRI/2023/09/057772 [Registered on: 18/09/2023] Trial Registered Prospectively
Last Modified On: 16/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of prophylactic antibiotics for surgical site infection in patients operated for gall bladder removal laparoscopically  
Scientific Title of Study   The effect of antibiotic prophylaxis on surgical site infection following elective laparoscopic cholecystectomy: A randomised clinical trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharmendra Kumar Pipal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 101, Department of General Surgery, All India Institute of Medical Sciences

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  09602541730  
Fax    
Email  dr.dharmendrapipal2007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dharmendra Kumar Pipal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 101, Department of General Surgery, All India Institute of Medical Sciences

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  09602541730  
Fax    
Email  dr.dharmendrapipal2007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dharmendra Kumar Pipal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 101, Department of General Surgery, All India Institute of Medical Sciences

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  09602541730  
Fax    
Email  dr.dharmendrapipal2007@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery, All India Institute of Medical Sciences, Gorakhpur, U.P., India Pin code; 273008 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Gorakhpur, U.P., India Pin code; 273008 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
All India Institute of Medical Sciences  Gorakhpur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dharmendra Kumar Pipal  All India Institute of Medical Sciences   Room no 101, OPD Block, Department of General Surgery, All India Institute of Medical Sciences Pin 273008
Gorakhpur
UTTAR PRADESH 		 9602541730

dr.dharmendrapipal2007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC, All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K801||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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Same antibiotic is given postoperatively  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 
Intervention  Single dose of antibiotic prior to surgery  A single dose of Ceftriaxone 1 gm/ Cefazolin 2 mg 30 minutes before incision with no antibiotics in the postoperative period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Symptomatic Cholelithiasis
2. Any gender
3. 18- 60 years
4. ASA score I/II 
 
ExclusionCriteria 
Details  1. Comorbidities like DM, Malignancy, History of steroids, Immune suppression
2. Pregnancy
3. Laparoscopic Cholecystectomy converted to Open 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
(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). 		 sign of infection observed on
2,7,15 days postoperatively and after one month. 
 
Secondary Outcome  
Outcome  TimePoints 
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). 		 1 YEAR 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/09/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
 
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