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

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.

Study Overview

• Status: Recruiting
• Conditions: Malnutrition; Lung Cancer; Nutritional Deficiency
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Anticipated): 63

Contacts and Locations

• Study Contact: Name: Seda Eğilmez; Phone Number: 905063564052; Email: egilmezseda@gmail.com
• Study Contact Backup: Name: Nermin Kelebek Girgin; Phone Number: 905323875956; Email: nerminkelebek@yahoo.com

Study Locations

• Turkey
  • Nilüfer
    • Bursa, Nilüfer, Turkey, 16000
      • Recruiting
      • Bursa Uludağ Üniversitesi Tıp Fakültesi
      • Contact: Seda Eğilmez, 1; Phone Number: 905063564052; Email: egilmezseda@gmail.com
      • Contact: Nermin Kelebek Girgin, 2; Phone Number: 905323875956; Email: nerminkelebek@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

18 years and older patients who underwent lobectomy with a diagnosis lung cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Lung cancer scheduled lobectomy

Diagnostic test: Nutritional Risk Screening-2002; Nutritional Risk Screening-2002; Diagnostic test: Nutritional Risk Index; Nutritional Risk Index; Diagnostic test: Mini Nutritional Assessment; Mini Nutritional Assessment; Diagnostic test: Glasgow Prognostic Score; Glasgow Prognostic Score; Diagnostic test: Prognostic Nutritional Index; Prognostic Nutritional Index; Diagnostic test: Anthropometric measurements; middle arm circumference; Device: Handgrip strength test; Handgrip strength test

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Turkish Society of Anesthesiology and Reanimation

Publications and helpful links

General Publications

• Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.
• Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
• Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
• Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.
• McKenna NP, Bews KA, Al-Refaie WB, Colibaseanu DT, Pemberton JH, Cima RR, Habermann EB. Assessing Malnutrition Before Major Oncologic Surgery: One Size Does Not Fit All. J Am Coll Surg. 2020 Apr;230(4):451-460. doi: 10.1016/j.jamcollsurg.2019.12.034. Epub 2020 Feb 26.
• Neelemaat F, Kruizenga HM, de Vet HC, Seidell JC, Butterman M, van Bokhorst-de van der Schueren MA. Screening malnutrition in hospital outpatients. Can the SNAQ malnutrition screening tool also be applied to this population? Clin Nutr. 2008 Jun;27(3):439-46. doi: 10.1016/j.clnu.2008.02.002. Epub 2008 Apr 18.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Anticipated): June 8, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Nutrition Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Malnutrition
• Other Study ID Numbers: LungCancerMalnutrition

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