Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing GastrectomyNCT06261151
Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy
An observational study of Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing Gastrectomy, run by Shanghai Zhongshan Hospital.
Trial summary
Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing Gastrectomy
- What is being tested?
- Clinical data collection
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Mar 2025
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60-90 years old with gastric cancer who underwent radical gastrectomy were retrospectively analyzed from the prospectively collected database of Zhongshan Hospital of Fudan University between March 2024 and December 2024.
Who may be able to join
- Patients aged 60-90 years old; Patients with gastric cancer; Patients who underwent radical gastrectomy. -
Who cannot join
- Patients with other malignancies; Patients with previous gastrointestinal surgery or emergency surgery; Patients with incomplete medical record.
- -
About this study
Official title: Preoperative Nutritional Status and Risk Factors Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy: A Single-center Retrospective Study
Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome.
In China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management.
Previous studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention.
- Being tested
- Clinical data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data collectionOther
Clinical data of elderly patients with gastric cancer who underwent open gastrectomy were collected and analyzed.
What is being measured
The primary outcome is the main question the study is designed to answer.
The preoperative nutritional status of elderly patients underwent gastrectomy
According to the European Society for Clinical Nutrition and Metabolism (ESPEN) diagnostic criteria, malnutrition is defined as a weight loss of more than 10% (indefinite of time) or more than 5% over the last 3 months and a body mass index (BMI)<20 kg/m2 or <22 kg/m2 in patients under or above the age of 70, respectively. Nutritional assessment is performed based on a prognostic nutritional index (PNI), which is calculated based on the equation: [(10×serum albumin (g/dL)) + (0.005×total lymphocyte count (/mm3))].
Measured: March 01, 2024 to December 31, 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing GastrectomyStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261151
- Sponsor's protocol ID
- Zhongshan-HHY-03
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Nutritional Status and Risk Factors Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy: A Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06261151
- Acronym / sponsor ID
- Zhongshan-HHY-03
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 15 Feb 2024 (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.
Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome.
In China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management.
Previous studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60-90 years old with gastric cancer who underwent radical gastrectomy were retrospectively analyzed from the prospectively collected database of Zhongshan Hospital of Fudan University between March 2024 and December 2024.
Key inclusion criteria (1 listed)
- Patients aged 60-90 years old; Patients with gastric cancer; Patients who underwent radical gastrectomy. -
Key exclusion criteria (2 listed)
- Patients with other malignancies; Patients with previous gastrointestinal surgery or emergency surgery; Patients with incomplete medical record.
- -
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 |
|---|---|---|
| Clinical data collectionClinical data of elderly patients with gastric cancer who underwent open gastrectomy were collected and analyzed. | Other | – |
Primary outcome
The preoperative nutritional status of elderly patients underwent gastrectomy
Time frame: March 01, 2024 to December 31, 2024.
According to the European Society for Clinical Nutrition and Metabolism (ESPEN) diagnostic criteria, malnutrition is defined as a weight loss of more than 10% (indefinite of time) or more than 5% over the last 3 months and a body mass index (BMI)<20 kg/m2 or <22 kg/m2 in patients under or above the age of 70, respectively. Nutritional assessment is performed based on a prognostic nutritional index (PNI), which is calculated based on the equation: [(10×serum albumin (g/dL)) + (0.005×total lymphocyte count (/mm3))].
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing Gastrectomy, run by Shanghai Zhongshan Hospital.
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 1 inclusion and 2 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The preoperative nutritional status of elderly patients underwent gastrectomy (time frame: March 01, 2024 to December 31, 2024.). 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 15 Feb 2024.