| 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
|
|
|
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
|
|
|
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. |