Minia University Hospital
Minya, Minya Governorate, 61519, Egypt
Location status: Recruiting
NCT Number: NCT07144683
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Minya, Minya Governorate, 61519, Egypt
Location status: Recruiting
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:
Risk factors categorized as:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal)
Time frame: Within 30 days post-surgery.
Proportion of patients developing AL within 30 days post-surgery or during hospital stay (whichever longer), diagnosed clinically, radiologically, or operatively per ISGRC definition
Time frame: Within 30 days post-surgery
Graded as A (asymptomatic/mild, no treatment), B (requires intervention, no reoperation), or C (requires reoperation) per ISGRC.
Time frame: Within 30 days post-surgery
Proportion of patients requiring reoperation for AL.
Time frame: Within 30 days post-surgery
Proportion of patients readmitted for AL-related issues.
Time frame: Within 30 days post-surgery.
Duration of hospitalization (days) for patients with vs. without AL.
Time frame: Within 30 days post-surgery.
30-day and in-hospital mortality.
Time frame: Within 90 days post-surgery
Proportion of patients requiring permanent stoma due to AL.
Contact information is provided by the study sponsor or research team.
Minia University
Other
Risk Factors for Anastomotic Leakage After Colorectal Surgery.
Acronym: AL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07725692
Anastomotic Leak, Colon Cancer
Alexandria, Please Select, Egypt
View Trial DetailsNCT05153954
Anastomotic Leak, Colonic Diseases
Køge, Region Sjælland, Denmark
View Trial DetailsNCT04550156
Anastomotic Leak, Colonic Diseases
Liestal, Basel-Landschaft, Switzerland
View Trial DetailsNCT05164887
Anastomotic Leak, Colonic Diseases
Roma, Italy
View Trial Details