Anastomotic LeakALNCT07144683
Anastomotic Leakage After Colorectal Surgery.
An observational study of Anastomotic Leak and Colorectal Cancer, run by Minia University at 1 site in Egypt.
Trial summary
Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center observational cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anastomotic Leak, Colorectal Cancer, Diverticulitis
- What is being tested?
- Patients Undergoing Colorectal Resection with Anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 430 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2025to 25 Sep 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal). No intervention; observational only. Risk factors and outcomes will be monitored prospectively.
Who may be able to join
- Aged ≥18 years
- Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)
- Providing written informed consent
Who cannot join
- Colorectal resection without anastomosis (e.g., end stoma)
- Inflammatory bowel disease (Crohn's, ulcerative colitis)
- History of previous colorectal surgery involving anastomosis
- Pregnancy
- Unable to provide informed consent or comply with follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya, Minya Governorate, 61519
Saleh K Saleh, 01201765401 ext. +2, salehkhairy@mu.edu.eg
About this study
Official title: Risk Factors for Anastomotic Leakage After Colorectal Surgery.
Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center observational cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model. Approximately 430 patients undergoing colorectal resection with anastomosis will be enrolled from August 2025 to August 2026. Risk factors will be assessed preoperatively, intraoperatively, and postoperatively. AL will be defined and graded per the International Study Group of Rectal Cancer (ISGRC) criteria.
Read the detailed description
Anastomotic leakage (AL) remains a major complication after colorectal surgery, contributing to morbidity, mortality, prolonged hospital stays, and increased costs. Its etiology is multifactorial, involving patient, disease, and surgical factors. This study will prospectively evaluate risk factors in a single-center setting to minimize variability.
AL definition (per ISGRC): Defect at anastomotic site causing communication between intra/extraluminal compartments and luminal tract, diagnosed via clinical signs (e.g., peritonitis, fecal discharge), radiological evidence (e.g., CT showing extraluminal air/contrast or fluid collection), or operative verification.
Severity grading:
- Grade A: Asymptomatic/mild, no active treatment.
- Grade B: Requires intervention (e.g., drainage, antibiotics) but no reoperation.
- Grade C: Requires reoperation.
Risk factors categorized as:
- Preoperative: Demographics (age, sex, BMI), comorbidities (ASA score, diabetes....), lifestyle (smoking, alcohol), nutritional status (albumin, CRP), neoadjuvant therapy, medications, diagnosis (e.g., cancer, tumor location), and bowel preparation.
- Intraoperative: Approach (open/laparoscopic), resection type, anastomosis details (hand-sewn/stapled, level, perfusion assessment), peritoneal soiling, diverting stoma, operative time, blood loss/transfusion, drainage, surgeon experience, complications.
- Postoperative: AL diagnosis/severity/management, inflammatory response (CRP, WBC), anemia, complications (ileus, infection), hospital stay, nutritional support, mobilization, reoperation, ICU stay, mortality, pain management.Early detection of leak using inflammatory markers either in the serum or drain fluid. Drain fluid inflammatory markers (Drain Fluid Calprotectin(CP), Drain Fluid C-Reactive Protein (CRP), Drain Fluid Procalcitonin)and Serum inflammatory markers(Serum C-Reactive Protein (CRP), Serum Procalcitonin (PCT), Serum Lactate dehydrogenase (LDH)).
Data from electronic records, surgical notes, nursing charts, and follow-up. Statistical analysis includes descriptive stats, univariate/multivariate logistic regression for risk factors, subgroup analyses, and predictive model development/validation.
The study adheres to the Helsinki Declaration and Good Clinical Practice (GCP). Informed consent is required.
- Conditions
- Anastomotic Leak, Colorectal Cancer, Diverticulitis
- Being tested
- Patients Undergoing Colorectal Resection with Anastomosis
- Keywords
- Anastomotic leakage, Colorectal surgery, Risk factors, Postoperative complications, Predictive model
- Medical subject headings
- Anastomotic Leak, Colorectal Neoplasms, Diverticulitis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients Undergoing Colorectal Resection with AnastomosisProcedure or surgery
All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal)
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Colorectal Resection with Anastomosis | All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal). Risk factors and outcomes will be monitored prospectively. Receives: Procedure: Patients Undergoing Colorectal Resection with Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Anastomotic Leakage (AL)
Proportion of patients developing AL within 30 days post-surgery or during hospital stay (whichever longer), diagnosed clinically, radiologically, or operatively per ISGRC definition
Measured: Within 30 days post-surgery.
Secondary outcomes (6)
Severity of Anastomotic Leakage
Graded as A (asymptomatic/mild, no treatment), B (requires intervention, no reoperation), or C (requires reoperation) per ISGRC.
Measured: Within 30 days post-surgery
Reoperation Rate Due to AL
Proportion of patients requiring reoperation for AL.
Measured: Within 30 days post-surgery
Readmission Rate Due to AL
Proportion of patients readmitted for AL-related issues.
Measured: Within 30 days post-surgery
Length of Hospital Stay
Duration of hospitalization (days) for patients with vs. without AL.
Measured: Within 30 days post-surgery.
Mortality Rate
30-day and in-hospital mortality.
Measured: Within 30 days post-surgery.
Need for Permanent Stoma
Proportion of patients requiring permanent stoma due to AL.
Measured: Within 90 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 posted27 Aug 2025
- Study start25 Aug 2025
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 430 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Khairy Saleh MD, Minia University
- Investigators
- Saleh K Saleh, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144683
- Sponsor's protocol ID
- 1607/07/2025
- Acronym
- AL
- Status last verified
- May 2026
- First submitted
- 14 Aug 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Anastomotic Leakage After Colorectal Surgery.
- ClinicalTrials.gov ID
- NCT07144683
- Acronym / sponsor ID
- AL / 1607/07/2025
- Conditions
- Anastomotic Leak, Colorectal Cancer, Diverticulitis
- Keywords
- Anastomotic leakage, Colorectal surgery, Risk factors, Postoperative complications, Predictive model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 27 Aug 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 (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center observational cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model. Approximately 430 patients undergoing colorectal resection with anastomosis will be enrolled from August 2025 to August 2026. Risk factors will be assessed preoperatively, intraoperatively, and postoperatively. AL will be defined and graded per the International Study Group of Rectal Cancer (ISGRC) criteria.
Detailed description
Anastomotic leakage (AL) remains a major complication after colorectal surgery, contributing to morbidity, mortality, prolonged hospital stays, and increased costs. Its etiology is multifactorial, involving patient, disease, and surgical factors. This study will prospectively evaluate risk factors in a single-center setting to minimize variability.
AL definition (per ISGRC): Defect at anastomotic site causing communication between intra/extraluminal compartments and luminal tract, diagnosed via clinical signs (e.g., peritonitis, fecal discharge), radiological evidence (e.g., CT showing extraluminal air/contrast or fluid collection), or operative verification.
Severity grading:
- Grade A: Asymptomatic/mild, no active treatment.
- Grade B: Requires intervention (e.g., drainage, antibiotics) but no reoperation.
- Grade C: Requires reoperation.
Risk factors categorized as:
- Preoperative: Demographics (age, sex, BMI), comorbidities (ASA score, diabetes....), lifestyle (smoking, alcohol), nutritional status (albumin, CRP), neoadjuvant therapy, medications, diagnosis (e.g., cancer, tumor location), and bowel preparation.
- Intraoperative: Approach (open/laparoscopic), resection type, anastomosis details (hand-sewn/stapled, level, perfusion assessment), peritoneal soiling, diverting stoma, operative time, blood loss/transfusion, drainage, surgeon experience, complications.
- Postoperative: AL diagnosis/severity/management, inflammatory response (CRP, WBC), anemia, complications (ileus, infection), hospital stay, nutritional support, mobilization, reoperation, ICU stay, mortality, pain management.Early detection of leak using inflammatory markers either in the serum or drain fluid. Drain fluid inflammatory markers (Drain Fluid Calprotectin(CP), Drain Fluid C-Reactive Protein (CRP), Drain Fluid Procalcitonin)and Serum inflammatory markers(Serum C-Reactive Protein (CRP), Serum Procalcitonin (PCT), Serum Lactate dehydrogenase (LDH)).
Data from electronic records, surgical notes, nursing charts, and follow-up. Statistical analysis includes descriptive stats, univariate/multivariate logistic regression for risk factors, subgroup analyses, and predictive model development/validation.
The study adheres to the Helsinki Declaration and Good Clinical Practice (GCP). Informed consent is required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Colorectal Resection with Anastomosis | – | Procedure: Patients Undergoing Colorectal Resection with AnastomosisAll eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal). Risk factors and outcomes will be monitored prospectively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal). No intervention; observational only. Risk factors and outcomes will be monitored prospectively.
Key inclusion criteria (3 listed)
- Aged ≥18 years
- Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)
- Providing written informed consent
Key exclusion criteria (5 listed)
- Colorectal resection without anastomosis (e.g., end stoma)
- Inflammatory bowel disease (Crohn's, ulcerative colitis)
- History of previous colorectal surgery involving anastomosis
- Pregnancy
- Unable to provide informed consent or comply with follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients Undergoing Colorectal Resection with AnastomosisAll eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal) | Procedure or surgery | Patients Undergoing Colorectal Resection with Anastomosis |
Primary outcome
Incidence of Anastomotic Leakage (AL)
Time frame: Within 30 days post-surgery.
Proportion of patients developing AL within 30 days post-surgery or during hospital stay (whichever longer), diagnosed clinically, radiologically, or operatively per ISGRC definition
6 secondary outcomes
Severity of Anastomotic Leakage
Time frame: Within 30 days post-surgery
Reoperation Rate Due to AL
Time frame: Within 30 days post-surgery
Readmission Rate Due to AL
Time frame: Within 30 days post-surgery
Length of Hospital Stay
Time frame: Within 30 days post-surgery.
Mortality Rate
Time frame: Within 30 days post-surgery.
Need for Permanent Stoma
Time frame: Within 90 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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.
Saleh K Saleh, MD principal investigator
Minia University
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 Leak and Colorectal Cancer, run by Minia University at 1 site in Egypt.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 May 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saleh K Saleh, MD (01201765401 ext. +2, salehkhairy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Anastomotic Leakage (AL) (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 19 May 2026.