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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05417672
Other study ID # LungCancerMalnutrition
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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