Anastomotic Leakage in Colon SurgeryNCT07092631
Anastomotic Leakage in Colorectal Cancer Surgery in Syria
An observational study of Anastomotic Leakage in Colon Surgery and Anastomotic Leak Rectum, run by Elie Bitar at 1 site in Syria.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anastomotic Leakage in Colon Surgery, Anastomotic Leak Rectum, Anastomotic Leak Large Intestine
- How many people
- 119 participants
- Where
- 1 siteSyria
- Study dates
- 4 Jan 2016to 20 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: from the General Surgery Department of Damascus hospital, Damascus, Syria.
Who may be able to join
- Patients who underwent colorectal cancer surgery for tumor-related indications.
Who cannot join
- Emergency cases
- Non-tumor related colorectal surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anastomotic Leakage in Colorectal Cancer Surgery in Syria: Risk Factors and Improvements Following Guideline Implementation - A Retrospective Cohort Study
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.
Read the 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
- Keywords
- general surgery, Syria, leakage, colorectal cancer, rectum, guidelines implementation.
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start4 Jan 2016
- Primary completion8 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic Leakage in Colon SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elie Bitar
- Sponsor type
- University, hospital or other
- Collaborators
- Syrian Private University, Damascus Hospital
- Responsible party
- Sponsor-investigator, Elie Bitar, Syrian Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092631
- Sponsor's protocol ID
- IRB number 1497/436
- Status last verified
- Dec 2025
- First submitted
- 22 Jul 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anastomotic Leakage in Colorectal Cancer Surgery in Syria: Risk Factors and Improvements Following Guideline Implementation - A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07092631
- Acronym / sponsor ID
- IRB number 1497/436
- Conditions
- Anastomotic Leakage in Colon Surgery, Anastomotic Leak Rectum, Anastomotic Leak Large Intestine
- Keywords
- general surgery, Syria, leakage, colorectal cancer, rectum, guidelines implementation.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Elie BitarUniversity, hospital or other
- Collaborators
- Syrian Private University, Damascus Hospital
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- from the General Surgery Department of Damascus hospital, Damascus, Syria.
Key inclusion criteria (1 listed)
- Patients who underwent colorectal cancer surgery for tumor-related indications.
Key exclusion criteria (2 listed)
- Emergency cases
- Non-tumor related colorectal surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leakage in Colon Surgery and Anastomotic Leak Rectum, run by Elie Bitar at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between preoperative serum albumin level and incidence of anastomotic leakage following colorectal cancer surgery (time frame: Within 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.