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NCT Number: NCT07092631

Anastomotic Leakage in Colorectal Cancer Surgery in Syria

Anastomotic leakage is a serious complication of colorectal cancer surgery, particularly in resource-limited and conflict-affected settings. This retrospective cohort study conducted at Damascus Hospital, Syria, evaluated patient and procedure related risk factors for anastomotic leakage following elective sigmoid colon and rectal resections. An initial cohort (January 2016-March 2024) identified modifiable risk factors that informed updates to institutional preoperative and perioperative guidelines. A follow-up cohort (April 2024-October 2025) was subsequently analyzed to assess outcomes after guideline implementation. The study demonstrates that targeted optimization, especially correction of hypoalbuminemia and improved perioperative management was associated with reduced anastomotic leakage and postoperative mortality, highlighting the value of context-specific, evidence-based guideline changes in low-resource surgical settings.

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Key information

About this study

Anastomotic leakage (AL) remains one of the most severe complications following colorectal cancer surgery, leading to substantial morbidity, prolonged hospitalization, increased healthcare costs, and elevated postoperative mortality. The risk and impact of AL are particularly pronounced in low-resource and conflict-affected settings, where limitations in infrastructure, surgical equipment, and perioperative monitoring restrict both prevention and timely management. Despite extensive literature from high-income countries, data from war-affected regions such as Syria remain scarce.

This retrospective cohort study was conducted at the Department of General Surgery, Damascus Hospital, Syria, to identify risk factors associated with AL after elective sigmoid colon and rectal resections for colorectal adenocarcinoma and to evaluate outcomes following the implementation of revised institutional guidelines. The study comprised two sequential cohorts. The first cohort included patients operated on between January 2016 and March 2024 and served to identify patient and procedure related risk factors for AL. Findings from this initial analysis prompted revisions to local preoperative preparation and perioperative management protocols, with particular emphasis on nutritional optimization, correction of hypoalbuminemia, cautious use of perioperative blood transfusion, and intensified postoperative monitoring for high-risk patients.

A follow-up cohort was subsequently analyzed, including patients treated between April 2024 and October 2025 after implementation of the updated guidelines. Outcomes in this cohort were compared with those of the initial cohort to assess the clinical impact of the protocol changes. The primary outcome was the occurrence of anastomotic leakage, defined according to the International Study Group of Rectal Cancer (ISREC) criteria. Secondary outcomes included postoperative complications, perioperative blood transfusion, intensive care unit admission, and postoperative mortality.

All included patients underwent elective resection of the sigmoid colon or rectum for histologically confirmed colorectal adenocarcinoma. Emergency cases, non-neoplastic indications, and incomplete records were excluded. Surgical procedures were classified according to operative approach, anastomotic technique, anastomotic location, and use of diverting ileostomy. Data were retrospectively extracted from medical records and operative notes and verified through structured follow-up when available.

By comparing outcomes before and after guideline implementation, this study aims to demonstrate how locally driven, evidence-based modifications to perioperative care can reduce anastomotic leakage and improve surgical outcomes, even in settings constrained by prolonged conflict and limited resources.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent colorectal cancer surgery for tumor-related indications.

Exclusion criteria

  • Emergency cases
  • Non-tumor related colorectal surgeries

Treatment and study plan

Primary outcomes

  1. Correlation between preoperative serum albumin level and incidence of anastomotic leakage following colorectal cancer surgery

    Time frame: Within 30 days post-surgery

    Preoperative serum albumin concentration measured in g/dL using routine hospital laboratory biochemical analysis will be correlated with the incidence of anastomotic leakage. Anastomotic leakage will be assessed as a binary outcome (yes/no) based on clinical findings, radiological imaging (contrast-enhanced CT), and/or intraoperative confirmation within the postoperative follow-up period.

Sponsors and collaborators

Lead sponsor

Elie Bitar

Other

Collaborators

  • Damascus Hospital
  • Syrian Private University

Registry information

Official study title

Anastomotic Leakage in Colorectal Cancer Surgery in Syria: Risk Factors and Improvements Following Guideline Implementation - A Retrospective Cohort Study

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jan 6, 2026

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.

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