Gastrointestinal DiseaseNCT03930082
Frailty Assessment of Patients With Gastrointestinal Surgery
An observational study of Gastrointestinal Disease and Frail Elderly Syndrome, run by Ziqiang Wang,MD at 1 site in China.
Trial summary
Patients aged 65 or older under gastrointestinal surgery will be enrolled，the investigators will assess the frailty of these patients by Frailty Index Scale and explore the correlation between the frailty and perioperative adverse events. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Gastrointestinal Disease, Frail Elderly Syndrome
- What is being tested?
- Frailty Index Scale
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2021
- 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
- No healthy volunteers
- Older adult
Study population: Elderly patients aged 65 years or older who undergo gastrointestinal surgery in West China Hospital.
Who may be able to join
- Patients whose age not less than 65 years;
- undergoing operation in gastrointestinal surgery of West China hospital due to gastrointestinal disease.
Who cannot join
- Those who did not undergo surgery for various reasons;
- Death before operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Frailty Assessment in Elderly Patients Undergoing Gastrointestinal Surgery
Patients aged 65 or older under gastrointestinal surgery will be enrolled，the investigators will assess the frailty of these patients by Frailty Index Scale and explore the correlation between the frailty and perioperative adverse events.
Read the detailed description
Patients will be assessed by specially trained doctors or nurses after admission, including daily living ability, physiological function, social-psychological status, comorbidities, mental state, grip strength, walking speed. After the assessment, the patients' frailty index was obtained. Moreover, the operation time, intraoperative bleeding loss, perioperative complications, length of stay, hospitalization expenses, readmission rate within 30 days, mortality within 30 days and other outcome indicators of these patients will be recorded.
The Main purposes of present study are to verify the feasibility of applying Frailty Index (FI) to assess the degree of frailty in elderly patients undergoing gastrointestinal surgery, compare the difference of perioperative adverse events in elderly patients with different degrees of frailty，find potential indicators for evaluating and predicting the safety of surgery in elderly patients, and provide reference data for the determination of future assessment tools of frailty.
The secondary objective is to compare the quality of life and long-term prognosis(only for patients with cancers,including recurrence free survival and overall survival) of elderly patients with different degrees of frailty after gastrointestinal surgery.
- Conditions
- Gastrointestinal Disease, Frail Elderly Syndrome
- Being tested
- Frailty Index Scale
- Keywords
- Gastrointestinal surgery, Frailty, Elder patient, Complication
- Medical subject headings
- Gastrointestinal Diseases, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty Index ScaleOther
We will evaluate the frailty with a Frailty Index Scale in elderly patients undergoing gastrointestinal surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
From the beginning of the skin incision to the end of the last incision was From the beginning of the skin incision to the end of the suture of last incision
Measured: 2 year
Blood loss
intraoperative blood loss
Measured: 2 year
Intraoperative complications
Including all the complications in the procedure
Measured: 2 year
postoperative complications
including incision infection，anastomotic leakage，respiratory infection, postoperative bleeding and so on.
Measured: 2 year
The length of stay in intensive care unit (ICU)
Time form entry to ICU to return to general ward after the condition is stable.
Measured: 2 year
The length of hospitalization
Time from admission to discharge
Measured: 2 year
Hospital costs
Cost of diagnosis and treatment during hospitalization
Measured: 2 year
Readmission rate within 30 days
The proportion of patients who are re-hospitalized for postoperative complications after 30 days of discharge in all subjects.
Measured: 2 year
Mortality within 30 days
death rate within 30 days after surgery in all patients after operation
Measured: 2 year
Secondary outcomes (2)
Recurrence-free Survival (RFS)
RFS is the abbreviation of recurrence-free survival, which refers to the duration from postoperation to tumor recurrence (Only for patients with cancers).
Measured: 2 year
Overall survival (OS)
OS is the abbreviation of overall survival , which refers to the duration from postoperation to death of the subjects (Only for patients with cancers).
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziqiang Wang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ziqiang Wang,MD, West China Hospital
- Investigators
- Ziqiang Wang, MD,PHD, Study chair, Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930082
- Sponsor's protocol ID
- FA-PGS-2019
- Status last verified
- Nov 2020
- First submitted
- 4 Apr 2019
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Frailty Assessment in Elderly Patients Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT03930082
- Acronym / sponsor ID
- FA-PGS-2019
- Conditions
- Gastrointestinal Disease, Frail Elderly Syndrome
- Keywords
- Gastrointestinal surgery, Frailty, Elder patient, Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ziqiang Wang,MDUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 29 Apr 2019 (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.
Patients aged 65 or older under gastrointestinal surgery will be enrolled，the investigators will assess the frailty of these patients by Frailty Index Scale and explore the correlation between the frailty and perioperative adverse events.
Detailed description
Patients will be assessed by specially trained doctors or nurses after admission, including daily living ability, physiological function, social-psychological status, comorbidities, mental state, grip strength, walking speed. After the assessment, the patients' frailty index was obtained. Moreover, the operation time, intraoperative bleeding loss, perioperative complications, length of stay, hospitalization expenses, readmission rate within 30 days, mortality within 30 days and other outcome indicators of these patients will be recorded.
The Main purposes of present study are to verify the feasibility of applying Frailty Index (FI) to assess the degree of frailty in elderly patients undergoing gastrointestinal surgery, compare the difference of perioperative adverse events in elderly patients with different degrees of frailty，find potential indicators for evaluating and predicting the safety of surgery in elderly patients, and provide reference data for the determination of future assessment tools of frailty.
The secondary objective is to compare the quality of life and long-term prognosis(only for patients with cancers,including recurrence free survival and overall survival) of elderly patients with different degrees of frailty after gastrointestinal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients aged 65 years or older who undergo gastrointestinal surgery in West China Hospital.
Key inclusion criteria (2 listed)
- Patients whose age not less than 65 years;
- undergoing operation in gastrointestinal surgery of West China hospital due to gastrointestinal disease.
Key exclusion criteria (2 listed)
- Those who did not undergo surgery for various reasons;
- Death before operation
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 |
|---|---|---|
| Frailty Index ScaleWe will evaluate the frailty with a Frailty Index Scale in elderly patients undergoing gastrointestinal surgery. | Other | – |
Primary outcome
operative time
Time frame: 2 year
From the beginning of the skin incision to the end of the last incision was From the beginning of the skin incision to the end of the suture of last incision
Blood loss
Time frame: 2 year
intraoperative blood loss
Intraoperative complications
Time frame: 2 year
Including all the complications in the procedure
postoperative complications
Time frame: 2 year
including incision infection，anastomotic leakage，respiratory infection, postoperative bleeding and so on.
The length of stay in intensive care unit (ICU)
Time frame: 2 year
Time form entry to ICU to return to general ward after the condition is stable.
The length of hospitalization
Time frame: 2 year
Time from admission to discharge
Hospital costs
Time frame: 2 year
Cost of diagnosis and treatment during hospitalization
Readmission rate within 30 days
Time frame: 2 year
The proportion of patients who are re-hospitalized for postoperative complications after 30 days of discharge in all subjects.
Mortality within 30 days
Time frame: 2 year
death rate within 30 days after surgery in all patients after operation
2 secondary outcomes
Recurrence-free Survival (RFS)
Time frame: 2 year
Overall survival (OS)
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
Ziqiang Wang, MD,PHD study chair
Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
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 Gastrointestinal Disease and Frail Elderly Syndrome, run by Ziqiang Wang,MD at 1 site in China.
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 2 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 13 Nov 2020. 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 China. 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?
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?
operative time (time frame: 2 year). The study lists 9 primary outcomes in all. 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 13 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.