NCT07092631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2016

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

9.8 years

First QC Date

July 22, 2025

Last Update Submit

December 30, 2025

Conditions

Keywords

general surgerySyrialeakagecolorectal cancerrectumguidelines implementation.

Outcome Measures

Primary Outcomes (1)

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

    Within 30 days post-surgery

Study Arms (2)

The First Cohort

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

The follow-up cohort

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

from the General Surgery Department of Damascus hospital, Damascus, Syria.

You may qualify if:

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

You may not qualify if:

  • Emergency cases
  • Non-tumor related colorectal surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syrian Private University

Damascus, Syria

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Elie Wadie Bitar MD, Faculty of Medicine, Syrian Private University, Damascus, Syria.

Study Record Dates

First Submitted

July 22, 2025

First Posted

July 30, 2025

Study Start

January 4, 2016

Primary Completion

October 8, 2025

Study Completion

October 20, 2025

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations