FrailtyNCT06185270
Effects of Preoperative Frailty on Postoperative Recovery
An observational study of Frailty, run by Seoul National University Hospital.
Trial summary
This study aims to evaluate frailty using Short Physical Performance Battery (SPPB) before surgery and find out how frailty affects short-term postoperative recovery after surgery using Quality of Recovery-15 (QOR-15) questionnaire in patients undergoing minimally invasive distal gastrectomy for early gastric cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- SPPB
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2023to 25 Dec 2024
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery
Who may be able to join
- Patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery
Who cannot join
- Patients who have a difficulty in communication
- Patients who have a major medical or mental disease that can affect treatment outcome
- Patients unsuitable for this clinical trail on the opinion of researcher
About this study
Official title: Effects of Preoperative Frailty Assessed by Short Physical Performance Battery (SPPB) on Short-term Postoperative Recovery Among Gastric Cancer Patients Undergoing Minimally Invasive Distal Gastrectomy
This study aims to evaluate frailty using Short Physical Performance Battery (SPPB) before surgery and find out how frailty affects short-term postoperative recovery after surgery using Quality of Recovery-15 (QOR-15) questionnaire in patients undergoing minimally invasive distal gastrectomy for early gastric cancer.
Read the detailed description
As the elderly population increases, the evaluation and management of preoperative frailty is becoming important. In patients with frailty, exposure to external stress, such as surgery, can reduce physical function, increase postoperative complication, and raise the risk of death. This study aims to evaluate frailty using an automated device performing SPPB (Andantefit) and find out how frailty affects postoperative recovery.
- Conditions
- Frailty
- Being tested
- SPPB
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPPBDiagnostic test
Short Physical Performance Battery using the automated device (Andantefit)
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing minimally invasive distal gastrectomy for early gastric cancer | Not described Receives: Diagnostic Test: SPPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)
The minimum and maximum values of QoR-15K are 0 and 150, respectively. Higher scores mean better outcomes.
Measured: on postoperative day 3
Secondary outcomes (2)
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)
The minimum and maximum values of QoR-15K are 0 and 150, respectively. Higher scores mean better outcomes.
Measured: on postoperative day 1
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)
The minimum and maximum values of QoR-15K are 0 and 150, respectively. Higher scores mean better outcomes.
Measured: on postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start26 Dec 2023 (estimated)
- Primary completion25 Dec 2024 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Prospective
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185270
- Sponsor's protocol ID
- 2308-179-1462
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 29 Dec 2023
- 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Frailty Assessed by Short Physical Performance Battery (SPPB) on Short-term Postoperative Recovery Among Gastric Cancer Patients Undergoing Minimally Invasive Distal Gastrectomy
- ClinicalTrials.gov ID
- NCT06185270
- Acronym / sponsor ID
- 2308-179-1462
- Conditions
- Frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Dec 2023 (estimated)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 29 Dec 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.
This study aims to evaluate frailty using Short Physical Performance Battery (SPPB) before surgery and find out how frailty affects short-term postoperative recovery after surgery using Quality of Recovery-15 (QOR-15) questionnaire in patients undergoing minimally invasive distal gastrectomy for early gastric cancer.
Detailed description
As the elderly population increases, the evaluation and management of preoperative frailty is becoming important. In patients with frailty, exposure to external stress, such as surgery, can reduce physical function, increase postoperative complication, and raise the risk of death. This study aims to evaluate frailty using an automated device performing SPPB (Andantefit) and find out how frailty affects postoperative recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing minimally invasive distal gastrectomy for early gastric cancer | – | Diagnostic Test: SPPB |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery
Key inclusion criteria (1 listed)
- Patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery
Key exclusion criteria (3 listed)
- Patients who have a difficulty in communication
- Patients who have a major medical or mental disease that can affect treatment outcome
- Patients unsuitable for this clinical trail on the opinion of researcher
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 |
|---|---|---|
| SPPBShort Physical Performance Battery using the automated device (Andantefit) | Diagnostic test | Patients undergoing minimally invasive distal gastrectomy for early gastric cancer |
Primary outcome
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)
Time frame: on postoperative day 3
The minimum and maximum values of QoR-15K are 0 and 150, respectively. Higher scores mean better outcomes.
2 secondary outcomes
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)
Time frame: on postoperative day 1
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)
Time frame: on postoperative day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
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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.
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 Frailty, run by Seoul National University 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 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 29 Dec 2023. 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?
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122) (time frame: on postoperative day 3). 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 29 Dec 2023.