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Clinical Trials in Egypt / NCT07763379
Recruiting Observational

THE ROLE OF C-REACTIVE PROTEIN (CRP) IN THE EARLY DIAGNOSIS OF ANASTOMOTIC LEAKAGE FOLLOWING PRIMARY REPAIR IN GASTROINTESTINAL SURGERY

NCT07763379 · tracked via the Priya Life Science Egypt tracker
Sponsor
Sohag University
Phase
Observational
Started
2026-08-11
Last updated
2026-08-13

Condition(s) studied

Anastomosis, Leaking

Investigational drug(s) / intervention(s)

c-reactive protein

c-reactive protein: evaluate the role of postoperative CRP levels in the early diagnosis of anastomotic leakage after primary repair in gastrointestinal surgery. Additionally, the clinical utility of using serial CRP measurements as a simple, accessible, and cost-effective aid in the clinical management of patients.

Study summary

Despite advancements in surgical procedures, Anastomotic leakage (AL) remains a common complication following gastrointestinal surgery. It carries a high rate of morbidity and mortality, increases the cost of treatment, and leads to further interventions and delayed recovery. As surgical practice advances, AL becomes a significant obstacle for gastrointestinal surgeons worldwide (Smith et al., 2023).

The rate of AL depends on the type of operation, the location of the anastomosis, the disease itself, the method of surgery, and patient-related factors. Patient factors that contribute to AL include malnutrition, diabetes mellitus, smoking, obesity, steroid use, emergency operations, and poor blood flow to tissues (Johnson and Lee, 2024).

Even though AL begins with a small lesion in the area of the anastomosis, it can lead to extensive intra-abdominal sepsis, multiple organ failure, and death due to late diagnosis. Furthermore, in cases of oncological surgery, AL can negatively impact long-term outcomes because of delay in adjuvant treatment and increased recurrence (Brown et al., 2025).

Early identification of AL is quite challenging because postoperative symptoms are nonspecific and may resemble the common inflammatory reaction after major surgery. Symptoms including fever, tachycardia, abdominal pain, ileus, leukocytosis, or purulent drainage usually become visible only when the condition is already at an advanced stage. Radiologic tests including contrast-enhanced CT are effective methods in identifying complications. However, using these techniques in every patient after major surgery is neither feasible nor economical, and some early cases may be overlooked (Wilson et al., 2023).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Adult patients aged 18 years or older. 2. Patients having surgery for abdominal gastrointestinal disorders (esophageal- Gastric- small bowel -colon ) where a primary repair or anastomosis is performed such (pathological -traumatic ) 3. Patients fit for surgery 4. Patients who provide informed written consent. Exclusion Criteria: 1- Patients younger than 18 years. 2. Patients with pre-existing systemic infection or sepsis outside GIT 3. Patients with liver cirrhosis affecting CRP synthesis. 4. Patients receiving corticosteroids or immunosuppressive therapy. 5. Patients refusing participation in the study 6. Post operative wound infection

Primary outcome measure(s)

  • determine the role of CRP in early diagnosis of anastomotic leakage after gastrointestinal surgery — 7 days

Trial sites (1)

FacilityCityRegionStatus
Sohag University Sohag Sohag Governorate Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07763379 on ClinicalTrials.gov ↗ ← All trials in Egypt