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NCT Number: NCT07144683

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged ≥18 years
  • Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)
  • Providing written informed consent

Exclusion criteria

  • 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

Treatment and study plan

Patients Undergoing Colorectal Resection with Anastomosis

Procedure

All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal)

Primary outcomes

  1. 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

Secondary outcomes

  1. Severity of Anastomotic Leakage

    Time frame: Within 30 days post-surgery

    Graded as A (asymptomatic/mild, no treatment), B (requires intervention, no reoperation), or C (requires reoperation) per ISGRC.

  2. Reoperation Rate Due to AL

    Time frame: Within 30 days post-surgery

    Proportion of patients requiring reoperation for AL.

  3. Readmission Rate Due to AL

    Time frame: Within 30 days post-surgery

    Proportion of patients readmitted for AL-related issues.

  4. Length of Hospital Stay

    Time frame: Within 30 days post-surgery.

    Duration of hospitalization (days) for patients with vs. without AL.

  5. Mortality Rate

    Time frame: Within 30 days post-surgery.

    30-day and in-hospital mortality.

  6. Need for Permanent Stoma

    Time frame: Within 90 days post-surgery

    Proportion of patients requiring permanent stoma due to AL.

Study contacts

Contact information is provided by the study sponsor or research team.

Saleh K Saleh, MD

CONTACT

[email protected]

01201765401 ext. +2

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Risk Factors for Anastomotic Leakage After Colorectal Surgery.

Acronym: AL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
May 19, 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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