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

NCT ID: NCT05417672

Last Updated: 2022-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-29

Study Completion Date

2022-09-01

Brief Summary

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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

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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.

Conditions

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Lung Cancer Malnutrition Nutritional Deficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung cancer scheduled lobectomy

Nutritional Risk Screening-2002

Intervention Type DIAGNOSTIC_TEST

Nutritional Risk Screening-2002

Nutritional Risk Index

Intervention Type DIAGNOSTIC_TEST

Nutritional Risk Index

Mini Nutritional Assessment

Intervention Type DIAGNOSTIC_TEST

Mini Nutritional Assessment

Glasgow Prognostic Score

Intervention Type DIAGNOSTIC_TEST

Glasgow Prognostic Score

Prognostic Nutritional Index

Intervention Type DIAGNOSTIC_TEST

Prognostic Nutritional Index

Anthropometric measurements

Intervention Type DIAGNOSTIC_TEST

middle arm circumference

Handgrip strength test

Intervention Type DEVICE

Handgrip strength test

Interventions

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Nutritional Risk Screening-2002

Nutritional Risk Screening-2002

Intervention Type DIAGNOSTIC_TEST

Nutritional Risk Index

Nutritional Risk Index

Intervention Type DIAGNOSTIC_TEST

Mini Nutritional Assessment

Mini Nutritional Assessment

Intervention Type DIAGNOSTIC_TEST

Glasgow Prognostic Score

Glasgow Prognostic Score

Intervention Type DIAGNOSTIC_TEST

Prognostic Nutritional Index

Prognostic Nutritional Index

Intervention Type DIAGNOSTIC_TEST

Anthropometric measurements

middle arm circumference

Intervention Type DIAGNOSTIC_TEST

Handgrip strength test

Handgrip strength test

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkish Society of Anesthesiology and Reanimation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bursa Uludağ Üniversitesi Tıp Fakültesi

Bursa, Nilüfer, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Seda Eğilmez

Role: CONTACT

905063564052

Nermin Kelebek Girgin

Role: CONTACT

905323875956

Facility Contacts

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Seda Eğilmez, 1

Role: primary

905063564052

Nermin Kelebek Girgin, 2

Role: backup

905323875956

References

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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.

Reference Type BACKGROUND
PMID: 27642056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32113029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3820522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12765673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9990575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18395946 (View on PubMed)

Other Identifiers

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LungCancerMalnutrition

Identifier Type: -

Identifier Source: org_study_id

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