A clinical study to observe the antibiotic utilisation pattern in patients who underwent planned laparoscopic cholecystectomy in a medical college in Kolkata.
- Conditions
- Calculus of gallbladder with acutecholecystitis,
- Registration Number
- CTRI/2023/02/049945
- Lead Sponsor
- Somdatta Ghosh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 384
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.
- 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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (1)
College of Medicine and Sagore Dutta Hospital
🇮🇳Parganas, WEST BENGAL, India
College of Medicine and Sagore Dutta Hospital🇮🇳Parganas, WEST BENGAL, IndiaDr Soumya ChatterjeePrincipal investigator9830933488soumya.pg2011@gmail.com