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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417672
• Other study ID #: LungCancerMalnutrition
• Status: Recruiting
• Start date: September 29, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2022
• Source: Turkish Society of Anesthesiology and Reanimation
• Contact: Seda Egilmez
• Phone: 905063564052
• Email: egilmezseda[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: September 1, 2022
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Malnutrition
• Nutritional Deficiency

Intervention

Diagnostic Test:
• Nutritional Risk Screening-2002
Nutritional Risk Screening-2002
• Nutritional Risk Index
Nutritional Risk Index
• Mini Nutritional Assessment
Mini Nutritional Assessment
• Glasgow Prognostic Score
Glasgow Prognostic Score
• Prognostic Nutritional Index
Prognostic Nutritional Index
• Anthropometric measurements
middle arm circumference

Device:
• Handgrip strength test
Handgrip strength test

Locations

Country	Name	City	State
Turkey	Bursa Uludag Üniversitesi Tip Fakültesi	Bursa	Nilüfer

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Society of Anesthesiology and Reanimation

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak	a month after the surgery
Primary	Length of stay in the intensive care unit	Length of stay in the intensive care unit	up to 30 days
Primary	Length of hospital stay	Length of hospital stay	up to 30 days
Primary	Intraoperative hemodynamic complications	dysrhythmia, hypotension, hypertension, hemorrhage	during the procedure
Secondary	Oral intake	time to start oral intake and transition to adequate oral intake	up to 30 days
Secondary	pH	pH in arterial blood gas evaluation	during the procedure
Secondary	bicarbonate	bicarbonate level in arterial blood gas evaluation	during the procedure
Secondary	base excess	base excess in arterial blood gas evaluation	during the procedure
Secondary	lactate	lactate level in arterial blood gas evaluation	during the procedure
Secondary	glucose	glucose level in arterial blood gas evaluation	during the procedure