Actively Recruiting
Risk Factors for Anastomotic Leakage After Colorectal Surgery
Led by Minia University · Updated on 2026-05-19
430
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to identify and measure independent risk factors for anastomotic leakage (AL), a serious complication following colorectal surgery, with rates ranging from 2% to 30%. The study will assess AL's incidence and its impact on patient outcomes, using criteria from the International Study Group of Rectal Cancer. Approximately 430 patients undergoing colorectal resection with anastomosis will be enrolled over one year in a single-center, prospective observational study to reduce variability. Participants will undergo elective or emergency colorectal surgery with primary anastomosis, including ileocolic, colocolic, colorectal, or coloanal types. The study will monitor risk factors before, during, and after surgery, including demographic data, comorbidities, surgical details, and postoperative management. AL will be defined and graded by severity from mild without treatment to severe requiring reoperation. The study will also analyze inflammatory markers in serum and drain fluid to detect leaks early. During the study, researchers will collect data from medical records, surgical notes, and follow-up visits. They will evaluate outcomes such as AL incidence within 30 days post-surgery, severity, reoperation, readmission, hospital stay length, mortality, and the need for permanent stoma within 90 days. Statistical analysis will develop and validate predictive models for AL risk. The study follows ethical standards and requires informed consent from participants.
CONDITIONS
Brief Title
Anastomotic Leakage After Colorectal Surgery.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)
- Providing written informed consent
You will not qualify if you...
- Colorectal resection without anastomosis (e.g., end stoma)
- Diagnosis of inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- History of previous colorectal surgery involving anastomosis
- Pregnancy
- Unable to provide informed consent or comply with follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days post-surgery
Participants undergo colorectal resection with primary anastomosis. Post-surgery, participants are monitored for anastomotic leakage and other complications during their hospital stay.
Hospital stay with daily assessments
Duration - Up to 90 days post-surgery
Participants are followed for complications such as anastomotic leakage severity, reoperation, readmission, and overall recovery including mortality and stoma need.
Follow-up visits as needed within 90 days
Trial Site Locations
Total: 1 location
1
Minia University Hospital
Minya, Minya Governorate, Egypt, 61519
Actively Recruiting
Research Team
S
Saleh K Saleh, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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