Anastomotic Leakage After Colorectal Surgery.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMinia University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)
Providing written informed consent
Disqualifiers
Colorectal resection without anastomosis (e.g., end stoma)
Inflammatory bowel disease (Crohn's, ulcerative colitis)
History of previous colorectal surgery involving anastomosis
Pregnancy
Trial population
All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal). No intervention; observational only. Risk factors and outcomes will be monitored prospectively.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patients Undergoing Colorectal Resection with Anastomosis
Procedure/SurgeryAll eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal)
Treatment groups
430 Participants
are divided into 1 treatment groupGroup A: Patients Undergoing Colorectal Resection with Anastomosis1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Anastomotic Leakage (AL)
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.Secondary outcomes
1
Severity of Anastomotic Leakage
Graded as A (asymptomatic/mild, no treatment), B (requires intervention, no reoperation), or C (requires reoperation) per ISGRC.
Time frame
Within 30 days post-surgery2
Reoperation Rate Due to AL
Proportion of patients requiring reoperation for AL.
Time frame
Within 30 days post-surgery3
Readmission Rate Due to AL
Proportion of patients readmitted for AL-related issues.
Time frame
Within 30 days post-surgery4
Length of Hospital Stay
Duration of hospitalization (days) for patients with vs. without AL.
Time frame
Within 30 days post-surgery.Sponsors and contacts
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Source ClinicalTrials.gov