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Short term versus long term intravenous antimicrobial prophylaxis in Gastric, Colorectal and Gynaecological surgeries

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090433
Enrollment
84
Registered
2025-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C18- Malignant neoplasm of colon Health Condition 2: C54- Malignant neoplasm of corpus uteri Health Condition 3: C56- Malignant neoplasm of ovary Health Condition 4: C20- Malignant neoplasm of rectum Health Condition 5: C16- Malignant neoplasm of stomach

Interventions

Intervention1: Short-term antimicrobial prophylaxis: Short-term antimicrobial prophylaxis (24 hours post operative period). Route of administration: Intravenous. Injection Ceftriaxone 1000mg 12 hourly

Sponsors

Kaichun Thiumai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with ASA-I/II after elective curative surgery for Gastric, Colon and Gynaecological cancers in Surgical Oncology Department, AIIMS, Bhubaneswar

Exclusion criteria

Exclusion criteria: 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/m 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

Design outcomes

Primary

MeasureTime frame
Incidence of surgical site infection in short-term and long-term antimicrobial prophylaxis groupsTimepoint: 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

MeasureTime frame
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 therapyTimepoint:

Countries

India

Contacts

Public ContactKaichun Thiumai

All India Institute of Medical Sciences, Bhubaneswar, India

kaichunthiumai24@gmail.com08794865279

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026