Causes and outcomes of anastomotic leaks after colorectal surgery
Official title: Risk Factors for Anastomotic Leakage After Colorectal Surgery.
Run by Minia University · NCT07144683 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 430 (estimated) |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Status | Recruiting |
| Started | August 25, 2025 |
| Main results expected | March 25, 2027 |
| Study ends | April 25, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07144683 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.