Anastomotic Leakage After Colorectal Surgery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients Undergoing Colorectal Resection with Anastomosis.
- Who it may be relevant to
- Registry conditions: Anastomotic Leak, Colorectal Cancer, Diverticulitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Risk Factors for Anastomotic Leakage After Colorectal Surgery.
Overview
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
- 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)
Primary outcome measures
- Incidence of Anastomotic Leakage (AL) [Time frame: Within 30 days post-surgery.]
Secondary outcome measures (6)
- Severity of Anastomotic Leakage [Time frame: Within 30 days post-surgery]
- Reoperation Rate Due to AL [Time frame: Within 30 days post-surgery]
- Readmission Rate Due to AL [Time frame: Within 30 days post-surgery]
- Length of Hospital Stay [Time frame: Within 30 days post-surgery.]
- Mortality Rate [Time frame: Within 30 days post-surgery.]
- Need for Permanent Stoma [Time frame: Within 90 days post-surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Minia University Hospital — Minya
Identifiers
NCT: NCT07144683 · 1607/07/2025