Risk Factors for Anastomotic Leakage After Colorectal Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Incidence of Anastomotic Leakage (AL)
研究概览
简要总结
Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center observational cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model. Approximately 430 patients undergoing colorectal resection with anastomosis will be enrolled from August 2025 to August 2026. Risk factors will be assessed preoperatively, intraoperatively, and postoperatively. AL will be defined and graded per the International Study Group of Rectal Cancer (ISGRC) criteria.
详细描述
Anastomotic leakage (AL) remains a major complication after colorectal surgery, contributing to morbidity, mortality, prolonged hospital stays, and increased costs. Its etiology is multifactorial, involving patient, disease, and surgical factors. This study will prospectively evaluate risk factors in a single-center setting to minimize variability.
AL definition (per ISGRC): Defect at anastomotic site causing communication between intra/extraluminal compartments and luminal tract, diagnosed via clinical signs (e.g., peritonitis, fecal discharge), radiological evidence (e.g., CT showing extraluminal air/contrast or fluid collection), or operative verification.
Severity grading:
- Grade A: Asymptomatic/mild, no active treatment.
- Grade B: Requires intervention (e.g., drainage, antibiotics) but no reoperation.
- Grade C: Requires reoperation.
Risk factors categorized as:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)
- •Providing written informed consent
排除标准
- •Colorectal resection without anastomosis (e.g., end stoma)
- •Inflammatory bowel disease (Crohn's, ulcerative colitis)
- •History of previous colorectal surgery involving anastomosis
- •Pregnancy
- •Unable to provide informed consent or comply with follow-up
结局指标
主要结局
Incidence of Anastomotic Leakage (AL)
时间窗: Within 30 days post-surgery.
Proportion of patients developing AL within 30 days post-surgery or during hospital stay (whichever longer), diagnosed clinically, radiologically, or operatively per ISGRC definition
次要结局
- Readmission Rate Due to AL(Within 30 days post-surgery)
- Length of Hospital Stay(Within 30 days post-surgery.)
- Mortality Rate(Within 30 days post-surgery.)
- Need for Permanent Stoma(Within 90 days post-surgery)
- Severity of Anastomotic Leakage(Within 30 days post-surgery)
- Reoperation Rate Due to AL(Within 30 days post-surgery)
- Readmission Rate Due to AL(Within 30 days post-surgery)
- Length of Hospital Stay(Within 30 days post-surgery.)
- Mortality Rate(Within 30 days post-surgery.)
- Need for Permanent Stoma(Within 90 days post-surgery)
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University