Lung CancerNCT05890820
The Effect of Nutritional Risk Parameters on Postoperative Pulmonary Complications in Geriatric Thoracic Surgery Cases
An observational study of Lung Cancer and Nutrition, Healthy, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Preoperative evaluation of nutritional status in geriatric patients with lung cancer and implementation of these practices in elective patients are very important in terms of reducing postoperative complications and accelerating hospital discharge. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Cancer, Nutrition, Healthy, Postoperative Complications
- What is being tested?
- Preoperative nutritional assessment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 30 Oct 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: Patients over 65 years of age with lung malignancy and undergoing thoracic surgery.
Who may be able to join
- Patients over 65 years of age
- Lung Cancer
- Patients undergoing thoracic surgery
Who cannot join
- Refusal to participate in the study
- Patients with a diagnosis of hematological malignancy
- Patients with missing data required for research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Atatürk Sanatoryum Education and Research Hospital
Ankara, Keçioren, 06290
M. Ozgur Cirik, Assoc. Prof
About this study
Official title: Evaluation of the Effect of Preoperative Nutritional Risk Parameters on Postoperative Pulmonary Complications in Geriatric Patients Who Underwent Lung Resection for Malignancy, a Prospective Observational Study
Preoperative evaluation of nutritional status in geriatric patients with lung cancer and implementation of these practices in elective patients are very important in terms of reducing postoperative complications and accelerating hospital discharge. For this purpose, many nutritional assessments and measurements are used. Our aim in this study was to evaluate the relationship between preoperative nutritional status and postoperative pulmonary complications in patients undergoing thoracic surgery for geriatric lung cancer.
- Conditions
- Lung Cancer, Nutrition, Healthy, Postoperative Complications
- Being tested
- Preoperative nutritional assessment
- Medical subject headings
- Lung Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative nutritional assessmentOther
Preoperative nutritional assessment and postoperative pulmonary complications
What is being measured
The primary outcome is the main question the study is designed to answer.
FFMI - Fat-Free Mass Index
FFMI is an abbreviation for lean mass index. It defines the amount of your muscle mass relative to height and weight. The FFMI is part of the well-known and similar BMI family of body indexes. The effect of FFMI values on postoperative patient stay, intensive care unit stay, complications and postoperative mobilization time in lung cancer patients will be evaluated. Each patient will be evaluated by measuring the preoperative FFMI value 24 hours before.
Measured: 24 hours
Secondary outcomes (1)
BMI (Body Mass Index)
BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass. The effect of BMI values on postoperative patient stay, intensive care unit stay, complications and postoperative mobilization time in lung cancer patients will be evaluated. Each patient will be evaluated by measuring the preoperative BMI value 24 hours before.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start30 May 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Özgür Cirik, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890820
- Sponsor's protocol ID
- E-53610172-799-207700439
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Preoperative Nutritional Risk Parameters on Postoperative Pulmonary Complications in Geriatric Patients Who Underwent Lung Resection for Malignancy, a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05890820
- Acronym / sponsor ID
- E-53610172-799-207700439
- Conditions
- Lung Cancer, Nutrition, Healthy, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 30 May 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preoperative evaluation of nutritional status in geriatric patients with lung cancer and implementation of these practices in elective patients are very important in terms of reducing postoperative complications and accelerating hospital discharge. For this purpose, many nutritional assessments and measurements are used. Our aim in this study was to evaluate the relationship between preoperative nutritional status and postoperative pulmonary complications in patients undergoing thoracic surgery for geriatric lung cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients over 65 years of age with lung malignancy and undergoing thoracic surgery.
Key inclusion criteria (3 listed)
- Patients over 65 years of age
- Lung Cancer
- Patients undergoing thoracic surgery
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Patients with a diagnosis of hematological malignancy
- Patients with missing data required for research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative nutritional assessmentPreoperative nutritional assessment and postoperative pulmonary complications | Other | – |
Primary outcome
FFMI - Fat-Free Mass Index
Time frame: 24 hours
FFMI is an abbreviation for lean mass index. It defines the amount of your muscle mass relative to height and weight. The FFMI is part of the well-known and similar BMI family of body indexes. The effect of FFMI values on postoperative patient stay, intensive care unit stay, complications and postoperative mobilization time in lung cancer patients will be evaluated. Each patient will be evaluated by measuring the preoperative FFMI value 24 hours before.
1 secondary outcome
BMI (Body Mass Index)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Nutrition, Healthy, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Özgür Cirik Cirik, Assoc Prof (903123677235, dr.ozgurr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FFMI - Fat-Free Mass Index (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.