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CTRI Number  CTRI/2025/07/090433 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Short term versus long term intravenous antimicrobial prophylaxis in Gastric, Colorectal and Gynaecological surgeries 
Scientific Title of Study   Efficacy of short term versus long term intravenous antimicrobial prophylaxis in patients with ASA-I/II undergoing elective curative surgery for Gastric, Colon and Gynaecological cancers: A randomised control 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  Dillip Kumar Muduly 
Designation  Professor and head of department, Department of Surgical Oncology, AIIMS, Bhubaneswar 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar, India 
Address  Department of Surgical Oncology, AIIMS, Bhubaneswar, Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  9013072969  
Fax    
Email  dillipmuduly@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kaichun Thiumai 
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, Bhubaneswar, India 
Address  Department of Surgical Oncology, AIIMS, Bhubaneswar, Odisha, India

Khordha
ORISSA
751019
India 
Phone  08794865279  
Fax    
Email  kaichunthiumai24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kaichun Thiumai 
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, Bhubaneswar, India 
Address  Department of Surgical Oncology, AIIMS, Bhubaneswar,Sijua, Patrapada, Odisha

Khordha
ORISSA
751019
India 
Phone  08794865279  
Fax    
Email  kaichunthiumai24@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India PIN- 751019 
 
Primary Sponsor  
Name  Kaichun Thiumai 
Address  Department of Surgical Oncology, AIIMS, Bhubaneswar, Sijua, Patrapada, Odisha, India, PIN-751019 
Type of Sponsor  Other [Senior resident] 
 
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 
Kaichun Thiumai  All India Institute of Medical Sciences, Bhubaneswar  Department of Surgical Oncology, Sijua, Patrapada, Bhubaneswar, India
Khordha
ORISSA 		 08794865279

kaichunthiumai24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C18||Malignant neoplasm of colon, (2) ICD-10 Condition: C54||Malignant neoplasm of corpus uteri, (3) ICD-10 Condition: C56||Malignant neoplasm of ovary, (4) ICD-10 Condition: C20||Malignant neoplasm of rectum, (5) ICD-10 Condition: C16||Malignant neoplasm of stomach,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Long-term antimicrobial prophylaxis  Long-term antimicrobial prophylaxis (72 hours post operative period). Route of administration- intravenous. Injection Ceftriaxone 1000mg 12 hourly, injection Metronidazole 500mg 8 hourly till post-operative day 3. 
Intervention  Short-term antimicrobial prophylaxis  Short-term antimicrobial prophylaxis (24 hours post operative period). Route of administration: Intravenous. Injection Ceftriaxone 1000mg 12 hourly, Injection Metronidazole 500mg 8 hourly till randomisation on post operative day 1. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patients with ASA-I/II after elective curative surgery for Gastric, Colon and Gynaecological cancers in Surgical Oncology Department, AIIMS, Bhubaneswar
 
 
ExclusionCriteria 
Details  Patients with an ASA grade of III or higher
2. Age younger than 18 years or older than 65 years
3. Patients requiring antibiotics in the pre-operative period for at least 2 weeks prior to surgery
4. Presence of multiple uncontrolled comorbidities
5. Serum albumin level less than 3 g/dL
6. Hemoglobin level less than 9 g/dL
7. Patients with a BMI greater than 25 kg/m²
8. Pre-operative hospital stay exceeding 7 days
9. Patients who have not consented to participate in the study
10. Current smokers
11. Pregnant patients
12. Pre-operative use of immunosuppressive drugs
13. Patients undergoing emergency surgery
14. Class IV wounds (dirty wounds)
15. Intraoperative blood transfusion
16. Use of drains during surgery
17. Intraoperative spillage
18. Established symptoms and signs of infection
19. Post-operative hypotension requiring inotropes
20. Post-operative mechanical ventilation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of surgical site infection in short-term and long-term antimicrobial prophylaxis groups  Daily assessment till discharge from the hospital. Then post-operative days 7th, 14th, 30th, 45th, 60th and 90th. And every hospital visit in case of an event or emergency, requiring frequent visits. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of remote infections in short-term versus long-term antimicrobial prophylaxis groups
- Patterns of microorganisms in patients developing surgical site infections (SSIs) and patterns of antibiotic resistance in both groups
- Antibiotic-related adverse events
- Duration of hospital stay and rates of readmission
- Total monetary expenditures
- Overall surgical complications, including mortality and morbidity within 90 days
- Rates of reinitiating antibiotics
- Delays in administering adjuvant therapy 		  
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   28/07/2025 
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 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  

Surgical site infections (SSIs) pose a significant challenge in surgical oncology, increasing morbidity, prolonging hospital stays, and escalating healthcare costs. Patients undergoing curative surgeries for gastric, colorectal, and gynecological cancers are particularly susceptible due to complex procedures, potential intraoperative contamination, and patient-specific factors such as immunosuppression and comorbidities. While extended antimicrobial prophylaxis has traditionally been used in oncologic surgeries, recent guidelines advocate for short-term prophylaxis (typically a single dose or up to 24 hours post-surgery) in elective procedures. Evidence from randomized controlled trials and meta-analyses indicates that short-term prophylaxis is non-inferior to extended regimens in preventing SSIs, offering additional benefits such as reduced antibiotic resistance, fewer adverse events, and lower costs. This study aims to evaluate the efficacy of short-term versus extended antimicrobial prophylaxis, assess the adequacy of short-term regimens in cancer surgeries, and provide evidence-based recommendations to guide clinical practice.

 
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