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

Sponsor
Turkish Society of Anesthesiology and Reanimation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05417672
Collaborator
(none)
63
1
11.1
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
63 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Actual Study Start Date :
Sep 29, 2021
Anticipated Primary Completion Date :
Jun 8, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Postoperative complications [a month after the surgery]

    dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak

  2. Length of stay in the intensive care unit [up to 30 days]

    Length of stay in the intensive care unit

  3. Length of hospital stay [up to 30 days]

    Length of hospital stay

  4. Intraoperative hemodynamic complications [during the procedure]

    dysrhythmia, hypotension, hypertension, hemorrhage

Secondary Outcome Measures

  1. Oral intake [up to 30 days]

    time to start oral intake and transition to adequate oral intake

  2. pH [during the procedure]

    pH in arterial blood gas evaluation

  3. bicarbonate [during the procedure]

    bicarbonate level in arterial blood gas evaluation

  4. base excess [during the procedure]

    base excess in arterial blood gas evaluation

  5. lactate [during the procedure]

    lactate level in arterial blood gas evaluation

  6. glucose [during the procedure]

    glucose level in arterial blood gas evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bursa Uludağ Üniversitesi Tıp Fakültesi Bursa Nilüfer Turkey 16000

Sponsors and Collaborators

  • Turkish Society of Anesthesiology and Reanimation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Turkish Society of Anesthesiology and Reanimation
ClinicalTrials.gov Identifier:
NCT05417672
Other Study ID Numbers:
  • LungCancerMalnutrition
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022