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

August 10, 2026 updated by: Mahmoud Elsayed Hussien, Sohag University

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).

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypt, 82516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
THE ROLE OF C-REACTIVE PROTEIN (CRP) IN THE EARLY DIAGNOSIS OF ANASTOMOTIC LEAKAGE FOLLOWING PRIMARY

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
determine the role of CRP in early diagnosis of anastomotic leakage after gastrointestinal surgery
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • J Clin Med. 2024;13(7):2055
  • updated review. World J Gastrointest Surg. 2024;16(2):88-97
  • Ann Surg. 2023;278(4):512-520

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 11, 2026

Primary Completion (Estimated)

January 11, 2027

Study Completion (Estimated)

January 12, 2027

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-26-7-6MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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