Anastomotic Leakage in Colorectal Cancer Surgery in Syria

NCT ID: NCT07092631

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-04
• Study Completion Date: 2025-10-20

Brief Summary

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.

Detailed Description

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.

Conditions

Anastomotic Leakage in Colon Surgery; Anastomotic Leak Rectum; Anastomotic Leak Large Intestine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

The First Cohort

Pre-guideline cohort - patients treated before the implementation of the updated hospital guidelines (January 2016 - March 2024).

No interventions assigned to this group

The follow-up cohort

Post-guideline cohort - patients treated after the implementation of the updated guidelines (April 2024 - October 2025).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Emergency cases
• Non-tumor related colorectal surgeries

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syrian Private University

OTHER

Sponsor Role: collaborator

Damascus Hospital

OTHER

Sponsor Role: collaborator

Elie Bitar

OTHER

Sponsor Role: lead

Responsible Party

Elie Bitar

Elie Wadie Bitar MD, Faculty of Medicine, Syrian Private University, Damascus, Syria.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Syrian Private University

Damascus, , Syria

Countries

Syria

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Anastomotic Leakage in Syria- first cohort

View Document

Document Type: Study Protocol: Follow-Up Cohort on Anastomotic Leakage

View Document

Other Identifiers

IRB number 1497/436

Identifier Type: -

Identifier Source: org_study_id