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

NCT07763379 | Recruiting

• 1 other identifier: Soh-Med-26-7-6MS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anastomosis, Leaking

Outcome Measures

Primary Outcomes (1)

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

  7 days

Study Arms (1)

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

Diagnostic Test: c-reactive protein

Interventions

c-reactive protein DIAGNOSTIC_TEST

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult surgical patients undergoing gastrointestinal surgery that requires a primary repair or anastomosis whether elective or emergent will be included in this study.

You may qualify if:

• Adult patients aged 18 years or older.
• Patients having surgery for abdominal gastrointestinal disorders (esophageal- Gastric- small bowel -colon ) where a primary repair or anastomosis is performed such (pathological -traumatic )
• Patients fit for surgery
• Patients who provide informed written consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, 82516, Egypt

RECRUITING

Related Publications (3)

• J Clin Med. 2024;13(7):2055

  RESULT

• updated review. World J Gastrointest Surg. 2024;16(2):88-97

  RESULT

• Ann Surg. 2023;278(4):512-520

  RESULT

Central Study Contacts

Mahmoud Elsayed Hussein, resident

CONTACT

+201151575156; Mahmoud.hussin@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start: August 11, 2026
• Primary Completion (Estimated): January 11, 2027
• Study Completion (Estimated): January 12, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

EG (1)