Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy

• Conditions: Lung Cancer; Malnutrition; Nutritional Deficiency
• Interventions: Diagnostic Test: Nutritional Risk Screening-2002; Diagnostic Test: Nutritional Risk Index; Diagnostic Test: Mini Nutritional Assessment; Diagnostic Test: Glasgow Prognostic Score; Diagnostic Test: Prognostic Nutritional Index; Diagnostic Test: Anthropometric measurements; Device: Handgrip strength test

• Registration Number: NCT05417672
• Lead Sponsor: Turkish Society of Anesthesiology and Reanimation

Brief Summary

Malnutrition is common in patients with lung cancer. In patients with malnutrition risk, the risk of complications is high both in the perioperative, early and late postoperative periods. Malnutrition is an independent risk factor for length of hospital stay and cost in these patients. Patients with lung cancer may have many morbidities in postoperative period, especially problems with wound healing. Therefore, assessment of the nutritional status of patients with lung cancer should begin at the diagnosis stage.

Detailed Description

In patients with lung cancer scheduled for lobectomy, anthropometric measurements will be measured and the results of laboratory tests(albumin, prealbumin, creatinine, total lymphocyte count, C reactive protein), Nutritional Risk Screening-2002, Nutritional Risk Index, Mini Nutritional Assessment, Glasgow Prognostic Score, Prognostic Nutritional Index and neoadjuvant chemotherapy or not will be recorded in 72 hours before surgery. In addition, demographic information of the patients (name, surname, identification number, age, comorbidity, American Society of Anesthesiologists score) will be recorded. After the information is given to the patients, their written and verbal consent will be obtained.

In the operating room, routine monitoring (electrocardiography, invasive blood pressure measurement, arterial blood gas monitoring, peripheral oxygen saturation, end-tidal carbon dioxide measurement by capnography) will be applied to the patients in accordance with the standard protocol for elective lobectomy surgery.

Hemodynamic changes (eg. dysrhythmia, hypotension, hypertension, hemorrhage), metabolic status (pH, bicarbonate, base excess), lactate, glucose level in blood gas evaluation and intraoperative complications will be recorded during the intraoperative period.

In the postoperative period, length of stay in the intensive care unit, length of hospital stay, early complications (eg. dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak), time to start oral intake and transition to adequate oral intake will be recorded in the one-month postoperative period.

Study Timeline

• Study Start: 2021-09-29
• Status Verified: 2022-06
• Study First Submitted: 2022-06-02
• Primary Completion: 2022-06-08
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Having a diagnosis of lung cancer
• Lung lobectomy operation will be performed
• 18 years and older patients
• Having an American Society of Anesthesiologists score of 1, 2, 3
• Having approved and signed the informed consent form

Exclusion Criteria

• Patients who underwent lobectomy with a diagnosis other than lung cancer
• Patients younger than 18 years
• Patients with an American Society of Anesthesiologists score of 4 and above
• Patients who did not accept informed consent
• Patients who refused to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung cancer scheduled lobectomy	Nutritional Risk Index	-
Lung cancer scheduled lobectomy	Nutritional Risk Screening-2002	-
Lung cancer scheduled lobectomy	Mini Nutritional Assessment	-
Lung cancer scheduled lobectomy	Anthropometric measurements	-
Lung cancer scheduled lobectomy	Prognostic Nutritional Index	-
Lung cancer scheduled lobectomy	Handgrip strength test	-
Lung cancer scheduled lobectomy	Glasgow Prognostic Score	-

Primary Outcome Measures

Name	Time	Method
Postoperative complications	a month after the surgery	dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak
Length of stay in the intensive care unit	up to 30 days	Length of stay in the intensive care unit
Length of hospital stay	up to 30 days	Length of hospital stay
Intraoperative hemodynamic complications	during the procedure	dysrhythmia, hypotension, hypertension, hemorrhage

Secondary Outcome Measures

Name	Time	Method
Oral intake	up to 30 days	time to start oral intake and transition to adequate oral intake
bicarbonate	during the procedure	bicarbonate level in arterial blood gas evaluation
pH	during the procedure	pH in arterial blood gas evaluation
glucose	during the procedure	glucose level in arterial blood gas evaluation
base excess	during the procedure	base excess in arterial blood gas evaluation
lactate	during the procedure	lactate level in arterial blood gas evaluation

Trial Locations

Locations (1)

Bursa Uludağ Üniversitesi Tıp Fakültesi; 🇹🇷 Bursa, Nilüfer, Turkey