Anastomotic Leakage After Colorectal Surgery.

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:

• Preoperative: Demographics (age, sex, BMI), comorbidities (ASA score, diabetes....), lifestyle (smoking, alcohol), nutritional status (albumin, CRP), neoadjuvant therapy, medications, diagnosis (e.g., cancer, tumor location), and bowel preparation.
• Intraoperative: Approach (open/laparoscopic), resection type, anastomosis details (hand-sewn/stapled, level, perfusion assessment), peritoneal soiling, diverting stoma, operative time, blood loss/transfusion, drainage, surgeon experience, complications.
• Postoperative: AL diagnosis/severity/management, inflammatory response (CRP, WBC), anemia, complications (ileus, infection), hospital stay, nutritional support, mobilization, reoperation, ICU stay, mortality, pain management.Early detection of leak using inflammatory markers either in the serum or drain fluid. Drain fluid inflammatory markers (Drain Fluid Calprotectin(CP), Drain Fluid C-Reactive Protein (CRP), Drain Fluid Procalcitonin)and Serum inflammatory markers(Serum C-Reactive Protein (CRP), Serum Procalcitonin (PCT), Serum Lactate dehydrogenase (LDH)).

Data from electronic records, surgical notes, nursing charts, and follow-up. Statistical analysis includes descriptive stats, univariate/multivariate logistic regression for risk factors, subgroup analyses, and predictive model development/validation.

The study adheres to the Helsinki Declaration and Good Clinical Practice (GCP). Informed consent is required.

All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal). Risk factors and outcomes will be monitored prospectively.

Procedure: Patients Undergoing Colorectal Resection with Anastomosis

All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal)

Plazo: 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

Plazo: Within 30 days post-surgery

Graded as A (asymptomatic/mild, no treatment), B (requires intervention, no reoperation), or C (requires reoperation) per ISGRC.

Plazo: Within 30 days post-surgery

Proportion of patients requiring reoperation for AL.

Plazo: Within 30 days post-surgery

Proportion of patients readmitted for AL-related issues.

Plazo: Within 30 days post-surgery.

Duration of hospitalization (days) for patients with vs. without AL.

Plazo: Within 30 days post-surgery.

30-day and in-hospital mortality.

Plazo: Within 90 days post-surgery

Proportion of patients requiring permanent stoma due to AL.

Risk Factors for Anastomotic Leakage After Colorectal Surgery.