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Anastomotic Leakage After Colorectal Surgery.

Risk Factors for Anastomotic Leakage After Colorectal Surgery.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07144683
Acronym
AL
Enrollment
430
Registered
2025-08-27
Start date
2025-08-25
Completion date
2026-09-25
Last updated
2026-05-19

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

Conditions

Anastomotic Leak, Colorectal Cancer, Diverticulitis

Keywords

Anastomotic leakage, Colorectal surgery, Risk factors, Postoperative complications, Predictive model

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREPatients Undergoing Colorectal Resection with Anastomosis

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

Sponsors

Minia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Aged ≥18 years * Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal) * Providing written informed consent

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Anastomotic Leakage (AL)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

Secondary

MeasureTime frameDescription
Severity of Anastomotic LeakageWithin 30 days post-surgeryGraded as A (asymptomatic/mild, no treatment), B (requires intervention, no reoperation), or C (requires reoperation) per ISGRC.
Reoperation Rate Due to ALWithin 30 days post-surgeryProportion of patients requiring reoperation for AL.
Readmission Rate Due to ALWithin 30 days post-surgeryProportion of patients readmitted for AL-related issues.
Length of Hospital StayWithin 30 days post-surgery.Duration of hospitalization (days) for patients with vs. without AL.
Mortality RateWithin 30 days post-surgery.30-day and in-hospital mortality.
Need for Permanent StomaWithin 90 days post-surgeryProportion of patients requiring permanent stoma due to AL.

Countries

Egypt

Contacts

CONTACTSaleh K Saleh, MD
salehkhairy@mu.edu.eg01201765401
PRINCIPAL_INVESTIGATORSaleh K Saleh, MD

Minia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026