| CTRI Number |
CTRI/2023/02/049945 [Registered on: 21/02/2023] Trial Registered Prospectively |
| Last Modified On: |
02/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to observe the antibiotic utilisation pattern in patients who underwent planned laparoscopic cholecystectomy in a medical college in Kolkata. |
|
Scientific Title of Study
|
An observational clinical study on antibiotic utilization pattern among patients undergoing elective laparoscopic cholecystectomy at a tertiary care medical training institution in Kolkata. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somdatta Ghosh |
| Designation |
Post Graduate Trainee, Department of Pharmacology |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
Department of Pharmacology
College of Medicine and Sagore Dutta Hospital
578 BT Road, Kamarhati,
Kolkata- 700058
P-106A, Unique Park, Behala
Kolkata- 700034
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
7980660558 |
| Fax |
|
| Email |
somdattaghosh16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Chatterjee |
| Designation |
Associate Professor, Department of Pharmacology, North Bengal Medical College and Hospital |
| Affiliation |
West Bengal University of Health Sciences |
| Address |
North Bengal Medical College and Hospital
D-5 Quarter, Sushruta Nagar, Siliguri,
West Bengal- 734012
Darjiling
WEST BENGAL
734012
India |
| Phone |
9830933488 |
| Fax |
|
| Email |
soumya.pg2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somdatta Ghosh |
| Designation |
Post Graduate Trainee, Department of Pharmacology, College of Medicine and Sagore Dutta Hospital |
| Affiliation |
West Bengal University of Health Sciences |
| Address |
578 BT Road, Kamarhati
Kolkata- 700058
P-106A, Unique Park, Behala
Kolkata- 700034
District- Kolkata
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
7980660558 |
| Fax |
|
| Email |
somdattaghosh16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology
College of Medicine and Sagore Dutta Hospital
578 BT Road, Kamarhati, Kolkata-700058 |
|
|
Primary Sponsor
|
| Name |
Somdatta Ghosh |
| Address |
Department of Pharmacology
College of Medicine and Sagore Dutta Hospital
578 BT Road, Kamarhati, Kolkata- 700058
578 BT Road, Kamarhati
Kolkata- 700058 |
| Type of Sponsor |
Other [Self- sponsored study] |
|
|
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 Soumya Chatterjee |
College of Medicine and Sagore Dutta Hospital |
Department of General Surgery
Male and Female wards
578 BT Road, Kamarhati
Kolkata- 700058
North Twentyfour Parganas
WEST BENGAL |
9830933488
soumya.pg2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College of Medicine and Sagore Dutta Hospital, 578 BT Road, Kolkata- 700058 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients both male and female, who underwent elective laparoscopic cholecystectomy in the Department of General Surgery at College of Medicine and Sagore Dutta Hospital shall be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients who refuse to give consent to the study and patients with incomplete treatment record, shall be exluded. Also the patients presenting with surgical emergencies shall be excluded from this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the post-operative antibiotic utilization pattern among patients undergoing elective laparoscopic cholecystectomy at a tertiary care medical training institution in Kolkata, over a period of 8 months. |
Baseline data will be collected. Since this is a cross-sectional study there will be no follow-ups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the WHO core prescribing indicators and prescribing trends of antibiotics during the post-operative period, over a period of 8 months. |
Baseline data will be collected. Since this is a cross-sectional study there shall be no follow-ups. |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
01/03/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study titled, "An observational clinical study on antibiotic utilization pattern among patients undergoing elective laparoscopic cholecystectomy at a tertiary care medical training institution in Kolkata." is aimed at studying the different antibiotic regimes prescribed to patients in the post-operative period. This is a cross-sectional study, where the data shall be collected from the bedside treatment records of the patients admitted in the General Surgery ward of College of Medicine and Sagore Dutta Hospital. Cholecystectomy is the surgical removal of the gall bladder and it is one of the most widely performed surgeries in the Hospital. The laparoscopic approach is preferred to the open cholecystectomy due to it being a faster technique, having rapid recovery and shorter duration of hospital stay. In accordance to the WHO prescribing indicators used to study drug utilisation patterns, the target sample size is taken to be 384. The study duration is one year and all the adult patients aged between 18-65 years, who underwent elective laparoscopic cholecystectomy shall be recruited for this study. Patients with incomplete treatment records and the ones presenting with surgical emergencies shall be excluded from this study. This study aims to observe the antibiotic utilisation pattern in the post-operative phase and if the prescribing trends adhere to the WHO core prescribing indicators. Data shall be collected over a period of 8 months and then data analysis shall be done over the next 4 months. Informed consent shall be taken from each patient, prior to proceeding with the study. This is a self-sponsored, non-invasive, cross-sectional, observational study. |