An Observational Study on Validity of DULK Score as a Tool for Early Diagnosis of Anastomotic Leakage in the Immediate Post-Operative Period After Elective Primary Intestinal Anastomosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- ANASTOMOTIC LEAK
研究概览
简要总结
Anastomotic leak is a commonly seen post-operative complication in patients who undergo bowel anastomosis. The outcome of which can range from conservative management to re-exteriorisation of bowel loop. This apart from financial distress can cause psychological impact on patient and his/her family. Understanding the risk factors identified, such as age, chronic diseases, anemia, and surgical variables, can aid healthcare providers in risk assessment, preoperative optimization, and postoperative monitoring to reduce the occurrence of anastomotic leaks.
By implementing strategies to address these risk factors, healthcare systems can improve patient outcomes, reduce complications, and enhance the quality of care provided to individuals undergoing surgical procedures, ultimately contributing to better public health outcomes and healthcare resource utilization.
详细描述
Study Population This study was conducted on a cohort of 86 patients who underwent elective open intestinal anastomosis at SMS Medical College, Jaipur. The patient population consisted of 48 males (59%) and 38 females (41%). The average age of the participants was 42.68 years, with a broad age range that allowed for the analysis of age-related risk factors in relation to anastomotic leaks (AL).
Risk Factors Considered for Anastomotic Leaks (AL)
Age and Gender:
The study explored the relationship between age and the incidence of anastomotic leaks, particularly focusing on age groups above 60 years. Gender-related patterns were also assessed.
Chronic Diseases:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who provided informed consent to participate in the study.
- •Patients aged 18 years or older.
- •Patients who underwent elective intestinal anastomosis in a planned operation (elective OT).
- •Patients with a single-site intestinal anastomosis.
排除标准
- •Patients operated on in an emergency setting.
- •Patients who underwent anastomosis at multiple sites (e.g., multiple bowel resections, whipples operation).
- •Patients lost to follow-up during the post-operative period.
- •Patients who were unable or unwilling to provide informed consent.
- •Pregnant or breastfeeding women, as the study interventions may not be suitable during these periods.
- •Patients with significant cognitive impairments or psychiatric disorders that would limit their ability to understand the study protocol or provide informed consent.
结局指标
主要结局
ANASTOMOTIC LEAK
时间窗: 12 DAYS
The primary outcome measure is the incidence of anastomotic leaks (AL) in patients who undergo elective intestinal anastomosis at SMS Medical College, Jaipur. AL is defined as the failure of the bowel anastomosis to properly heal, leading to the leakage of intestinal contents into the peritoneal cavity, which may result in peritonitis or sepsis. The incidence is assessed in the postoperative period, primarily within the first 12 days following surgery.
次要结局
未报告次要终点
研究者
DARSHAN KUMAR RATHOR
Resident Doctor, Department of General Surgery
Sawai Mansingh Medical College