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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
THE ROLE OF C-REACTIVE PROTEIN (CRP) IN THE EARLY DIAGNOSIS OF ANASTOMOTIC LEAKAGE FOLLOWING PRIMARY
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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