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Recruiting
NCT07144683
Anastomotic Leakage After Colorectal Surgery.
Conditions: Anastomotic Leak, Colorectal Cancer, Diverticulitis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 430
Sponsor: Minia University
Location: Minia University Hospital Minya Minya Governorate
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.
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
Source: ClinicalTrials.gov (NCT07144683). StuddyBuddy aggregates publicly available trial information.