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临床试验/CTRI/2025/07/090433
CTRI/2025/07/090433尚未招募不适用

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

Kaichun Thiumai1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年7月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
Incidence of surgical site infection in short-term and long-term antimicrobial prophylaxis groups

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • Patients with an ASA grade of III or higher
  • Age younger than 18 years or older than 65 years
  • Patients requiring antibiotics in the pre-operative period for at least 2 weeks prior to surgery
  • Presence of multiple uncontrolled comorbidities
  • Serum albumin level less than 3 g/dL
  • Hemoglobin level less than 9 g/dL
  • Patients with a BMI greater than 25 kg/m²
  • Patients who have not consented to participate in the study
  • Current smokers
  • Pregnant patients
  • Pre-operative use of immunosuppressive drugs
  • Patients undergoing emergency surgery
  • Class IV wounds (dirty wounds)
  • Intraoperative blood transfusion
  • Intraoperative spillage
  • Post-operative hypotension requiring inotropes
  • Post-operative mechanical ventilation.

结局指标

主要结局

Incidence of surgical site infection in short-term and long-term antimicrobial prophylaxis groups

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Kaichun Thiumai
申办方类型
Other [Senior resident]
责任方
Principal Investigator
主要研究者

Dillip Kumar Muduly

All India Institute of Medical Sciences, Bhubaneswar, India

研究点 (1)

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