C-Reactive Protein and Sodium in Predicting Anastomotic Leakage

NCT04717648 | Completed

• 1 other identifier: 2020/13-51
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Anastomotic leakage is serious morbidity that can develop in patients operated on for colorectal cancer and can reach potentially life-threatening dimensions. Many international studies have been conducted to reduce and eliminate this postoperative complication that may have a mortal course. In these studies, preoperative, perioperative and postoperative factors of the patient, operation techniques, structure of the material used in the operation and multiple factors belonging to the surgeon were held responsible. Intraabdominal sepsis secondary to late anastomotic leakage and subsequent multiorgan failure can cost the patient's life. Anastomotic leaks that develop in patients who have been operated for colorectal cancer; In order to detect patients' postoperative clinical findings, laboratory examinations, imaging tests, and to eliminate them before intraabdominal sepsis develops, studies including many different laboratory and imaging methods have been carried out. Although previous studies have shown that there are many laboratory examinations and imaging methods that can predict anastomotic leaks early, they have many advantages over each other in terms of efficiency, sensitivity, specificity, and cost. The investigators aimed to investigate the effectiveness of C reactive protein and blood sodium value, as well as their superiority, among the tests that can predict postoperative anastomotic leakage, especially in patients who have undergone a single anastomosis following resection for non-metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

anastomotic leak; hyponatremia; colorectal carcinoma; c-reactive protein

Outcome Measures

Primary Outcomes (1)

• Early predictive factors of anastomotic leakege

  The anastomotic leak of the measurement The measurement tool is the laboratory parameters.

  2 or 3 days

Study Arms (2)

Patients with anastomotic leakage

Post operative anastomotic leakage

Diagnostic Test: Biochemical test

Patients without anastomotic leakage

Post operative without anastomotic leakage

Diagnostic Test: Biochemical test

Interventions

Biochemical test DIAGNOSTIC_TEST

C Reactive protein and sodium

Patients with anastomotic leakage; Patients without anastomotic leakage

Eligibility Criteria

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

Study Population

All patients eligible for inclusion criteria

You may qualify if:

• Patients over the age of 18 who were operated due to elective colorectal cancer
• Patients who are known to have no solid organ metastases in preoperative imaging methods and whose perioperative surgery notes support this finding
• Patients with ileocolic, colocolic, colorectal anastomosis during the operation
• Patients whose postoperative 1,3,5th day C- Reactive protein and sodium values were measured

You may not qualify if:

• Patients under the age of 18
• Emergency operated patients
• Patients on a routine dialysis program due to Chronic renal failure
• Patients with a known diagnosis of liver cirrhosis
• Patients who are irresectable during the operation and therefore have undergone palliative surgery
• Patients whose C- Reactive protein and Sodium values were not measured on the postoperative 1, 3, 5th day
• Patients with abdominoperineal resection and no bowel anastomosis during the operation
• Patients who have not undergone ileocolic, colocolic, colorectal or ileorectal anastomosis during the operation.
• Patients found to be metastatic during the operation
• Patients who have undergone additional surgical resection (metastasectomy, etc.) due to solid organ metastasis during the operation
• Patients who have had more than one gastrointestinal anastomosis during the same surgery
• Patients undergoing concurrent hyperthermic intraperitoneal chemotherapy (HIPEC) and / or cytoreductive surgery

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, 35180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak; Hyponatremia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 22, 2021
• Study Start: January 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 3, 2021

Record last verified: 2021-01

Locations

TU (1)