Causes and outcomes of anastomotic leaks after colorectal surgery
Risk Factors for Anastomotic Leakage After Colorectal Surgery.
This project will try to identify which pre-, intra-, and post-operative factors predict anastomotic leakage and build a prediction model for adults having colorectal resection with bowel reconnection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 430 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07144683 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center observational cohort enrolling about 430 adults undergoing colorectal resection with primary anastomosis to measure the incidence, severity, and outcomes of anastomotic leakage. Investigators will collect standardized preoperative, intraoperative, and postoperative data and define leakage and grading according to the International Study Group of Rectal Cancer (ISGRC) criteria. The goal is to quantify independent risk factors and combine them into a predictive model to stratify patients by leak risk. Results will be used to describe clinical impact (morbidity, reoperation, length of stay) and inform perioperative decision-making.
Who should consider this trial
Good fit: Adults aged 18 or older undergoing elective or emergency colorectal resection with a planned primary anastomosis who can give informed consent are eligible.
Not a fit: Patients who do not receive an anastomosis (e.g., end stoma), those with inflammatory bowel disease, prior colorectal anastomosis, pregnancy, or inability to consent will be excluded and will not benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could help clinicians identify patients at high risk for leaks so they can target preventive measures and tailor perioperative care.
How similar studies have performed: Previous observational cohorts and predictive scores have identified many risk factors for anastomotic leakage but show variable performance and limited external validation, so this prospective single-center effort aims to refine and validate predictors.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minya, Minya Governorate
- Minia University Hospital — Minya, Minya Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Saleh K Saleh, MD — Minia University
- Study coordinator: Saleh K Saleh, MD
- Email: salehkhairy@mu.edu.eg
- Phone: 01201765401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.