Anastomotic Leakage in Colorectal Cancer Surgery in Syria: Risk Factors and Improvements Following Guideline Implementation - A Retrospective Cohort Study
Conditions: Anastomotic Leakage in Colon Surgery, Anastomotic Leak Rectum, Anastomotic Leak Large Intestine
Sponsor: Elie Bitar

Anastomotic Leakage in Colorectal Cancer Surgery in Syria: 
Risk Factors and Improvements Following Guideline 
Implementation – A Retrospective Cohort Study
November/16/2025
NCT07092631
Study Protocol: Follow-Up Cohort on Anastomotic Leakage in 
Colorectal Cancer Surgery at Damascus Hospital, Syria
Study Title:
Official Title:
Anastomotic Leakage in Colorectal Cancer Surgery in Syria: A Retrospective Cohort 
Study Before and After Guideline Implementation
Brief Title:
Anastomotic Leakage in Colorectal Cancer Surgery, Syria
Study Design:
•
Type: Observational, Retrospective Cohort Study
•
Number of Cohorts: Two sequential cohorts
•
The first cohort: Pre-guideline cohort (January 2016 – March 2024)
•
The follow-up cohort: Post-guideline follow-up cohort (April 2024 – October 2025)
•
Study Phase: N/A (observational)
•
Number of Par•cipants: 19 (follow-up cohort)
:
Study Objectives
•
Primary Objective:

1.
To evaluate the incidence of anastomotic leakage (AL) after implementation of 
updated institutional guidelines for colorectal cancer surgery.
•
Secondary Objectives:
1.
To assess postoperative complications, perioperative blood transfusions, ICU 
admissions, and postoperative mortality in the follow-up cohort.
2.
To compare outcomes with the pre-guideline cohort to determine the impact of 
guideline implementation.
3.
To evaluate the effectiveness of perioperative interventions targeting modifiable risk 
factors (e.g., hypoalbuminemia, transfusions, steroid use)
Study Setting:
Department of General Surgery, Damascus Hospital, Syria.
Resource-limited, conflict-affected environment with predominantly open surgery; 
laparoscopic surgery available for selected patients.
Eligibility Criteria:
•
Inclusion Criteria:
Patients who underwent elective resection of the sigmoid colon or rectum for histologically 
con•rmed colorectal adenocarcinoma between April 2024 and October 2025.
Availability of complete medical records and laboratory data relevant to the study 
outcomes.
•
Exclusion Criteria:
Emergency surgeries or non-elective resections.
Non-neoplastic (non-tumor) resections.
Incomplete or missing medical records.
Interventions / Exposure:
•
No experimental interventions; retrospective observational study.
•
Patients were managed under updated hospital guidelines, which included:
Preoperative nutritional optimization ) albumin Š3.5 g/dL when possible
( 
Reduced perioperative blood transfusions

Enhanced intraoperative safety protocols
Postoperative monitoring for high-risk patients
Outcome Measures:
•
Primary Outcome:
Anastomotic leakage (AL), defined according to ISREC criteria: a defect in the intestinal wall 
at the colorectal or colo-anal anastomosis causing communication between intra- and 
extraluminal compartments. Confirmed clinically or radiologically.
•
Secondary Outcomes:
Postoperative complications
ICU admission
Perioperative blood transfusions
Postoperative mortality
Data Collection:
Retrospective extraction from patient charts, operative notes, laboratory results, and 
radiology reports.
Structured follow-up telephone interviews where applicable.
Collected variables: demographics, lifestyle factors, comorbidities, tumor characteristics, 
surgical details, laboratory data, and postoperative outcomes.
Statistical Analysis:
Descriptive statistics for baseline characteristics.
Comparisons with pre-guideline cohort using Chi-square or Fisher’s exact test for categorical 
variables; t-test or Mann–Whitney U test for continuous variables.
Statistical significance: p • 0.05.
Analysis performed using SPSS version 24.
Ethical Considerations:
Ethical approval obtained from the Institutional Review Board of the Syrian Private 
University (IRB No. 1497/436 ).
Retrospective nature: waiver of informed consent obtained where applicable.
Patient confidentiality maintained via anonymization and secure data storage.

Timeline:
•
Study Start Date January 2016 (original cohort)
•
Follow-up Cohort Data Collec•on Start April 2024
•
Follow-up Cohort Data Collec•on End October 2025
•
Study Completion Date October 2025
Study Significance:
This follow-up cohort evaluates the real-world impact of evidence-based guideline 
modifications on anastomotic leakage and other postoperative outcomes in a resource-
limited, war-affected setting. The findings will inform future clinical practice and risk-
reduction strategies for colorectal surgery in similar low-resource contexts.