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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Undergoing Colorectal Resection with Anastomosis | All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal). Risk factors and outcomes will be monitored prospectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients Undergoing Colorectal Resection with Anastomosis | Procedure | All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 30 days post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Anastomotic Leakage | Graded as A (asymptomatic/mild, no treatment), B (requires intervention, no reoperation), or C (requires reoperation) per ISGRC. | Within 30 days post-surgery |
| Reoperation Rate Due to AL |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saleh K Saleh, MD | Contact | 01201765401 | +2 | salehkhairy@mu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Saleh K Saleh, MD | Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia University Hospital | Recruiting | Minya | Minya Governorate | 61519 | Egypt |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| D015179 | Colorectal Neoplasms |
| D004238 | Diverticulitis |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Proportion of patients requiring reoperation for AL.
| Within 30 days post-surgery |
| Readmission Rate Due to AL | Proportion of patients readmitted for AL-related issues. | Within 30 days post-surgery |
| Length of Hospital Stay | Duration of hospitalization (days) for patients with vs. without AL. | Within 30 days post-surgery. |
| Mortality Rate | 30-day and in-hospital mortality. | Within 30 days post-surgery. |
| Need for Permanent Stoma | Proportion of patients requiring permanent stoma due to AL. | Within 90 days post-surgery |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |