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CTRI Number  CTRI/2022/11/047440 [Registered on: 18/11/2022] Trial Registered Prospectively
Last Modified On: 18/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Removal of gall bladder by laparoscope without antibiotics 
Scientific Title of Study   Evaluation of surgical site infection in low-risk elective laparoscopic cholecystectomy with and without antibiotic prophylaxis- a randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anup Mohta 
Designation  Director-Professor 
Affiliation  Lady Hardinge Medical College 
Address  Room Number 304, Department of surgery New Academic Block, Lady Hardinge Medical College Shaheed Bhagat Singh Marg New Delhi

Central
DELHI
110001
India 
Phone    
Fax    
Email  mohtaanup@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anup Mohta 
Designation  Director-Professor 
Affiliation  Lady Hardinge Medical College 
Address  Room 304, Department of surgery, New academic Block, Lady Hardinge Medical College Shaheed Bhagat Singh Marg New Delhi

Central
DELHI
110001
India 
Phone    
Fax    
Email  mohtaanup@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anup Mohta 
Designation  Director-Professor 
Affiliation  Lady Hardinge Medical College 
Address  Room number 304, Department of surgery, New Academic Block Lady Hardinge medical College Shaheed Bhagat Singh Marg New Delhi

Central
DELHI
110001
India 
Phone    
Fax    
Email  mohtaanup@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College and associated Smt Sucheta Kriplani Hospital, New Delhi 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Shaheed Bhagat Singh Marg, New Delhi-110001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Supriya Raj  Sucheta Kriplani Hospital  Surgery ward, Department of Surgery Lady Hardinge Medical College New Delhi
Central
DELHI 
9958141815

supriyaraj3112@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research, Lady Hardinge Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Low risk elective laparoscopic cholecystectomy with prophylactic antibiotics  Prophylactic antibiotic 3rd generation cephalosporin ie Ceftriaxone 1 gm i.v. shall be administered within 30 minutes before incision as per Institutional antibiotic policy 
Intervention  Low risk elective laparoscopic cholecystectomy without prophylactic antibiotics  Antibiotic prophylaxis shall not be given to the study group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients for elective laparoscopic cholecystectomy of either gender with ASA Grade 1 
 
ExclusionCriteria 
Details  1) Antibiotic intake in 7 days prior to surgery
2) Regular corticosteroid therapy, immunodeficiency
3) Pregnancy or lactation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Odds ratio of patients who develop SSI with antibiotic prophylaxis

2. Odds ratio of patients who develop SSI without antibiotic prophylaxis  
Post operative Day 7 and 30 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   Not applicable 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   21/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Laparoscopic cholecystectomy (LC) is the standard treatment for symptomatic cholelithiasis. The main advantages of LC include less postoperative pain, shorter hospital stays, lower morbidity and mortality, and a lower rate of postoperative infection. The incidence of post-operative infectious complications after LC is significantly lower compared with that of open cholecystectomy. The use of prophylactic antibiotics as a means of preventing surgical site infection (SSIs) is a commonly practiced culture in uncomplicated or complicated elective LC. Many surgeons use and recommend the administration of prophylactic antibiotics . On the contrary, many surgeons believe that antibiotic prophylaxis may not be necessary in low-risk patients undergoing elective LC.  Surgical site infections is a significant postoperative complication which can lead to considerable patient morbidity and mortality. Preventing postoperative infection is an essential component in concluding the results of successful surgical procedures. One approach to prevent postoperative infection is administration of prophylactic antibiotics. The benefits of prophylactic antibiotics is to reduce bacterial contamination during clean-contaminated operations such as elective cholecystectomy.

Even though there are guidelines which don’t recommend antibiotic prophylaxis in elective laparoscopic surgeries , it is not being followed in India due to various reasons like Indian  hospitals are considered to have presumed doubtful sterilization practices , medicolegal issues, possible increase in cost to bear long hospital stay due to any postoperative infectious complications .

The aim of this study is to investigate the necessity of prophylactic antibiotics to prevent postoperative infectious complications in low-risk patients undergoing elective laparoscopic cholecystectomy. This will help reduce antibiotic resistance, irrational use, and unnecessary burden of cost, apart from promoting Antimicrobial Stewardship Program.

 There is no guidelines and minimal literature available on evaluation of role of prophylactic antibiotics in low risk elective laparoscopic cholecystectomy in India . The study results on this topic will benefit and contribute as an important quality index to hospitals in India and break the myth of presumed doubtful sterilization practices in Indian hospitals. This will also lead to rational antibiotic practices and promote Antimicrobial Stewardship Program.

 
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