Postoperative ComplicationsNCT07314762
Elderly Patients Undergoing Surgery During Perioperative Period
An observational study of Postoperative Complications and Elderly, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The elderly patients have poorer overall conditions and have lower tolerance to trauma, anesthesia, and surgery. Therefore, the incidence of postoperative complications is relatively higher. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications, Elderly, Postoperative Delirium (POD)
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2023to 30 Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Older adult
Study population: Surgical patients aged 65 or above or non-surgical subjects aged 65 or above
Who may be able to join
- 1) Surgical patients aged 65 or above or non-surgical subjects aged 65 or above. 2) Agree to participate in this study and sign the informed consent form.
Who cannot join
- 1）Refused to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Ting Li MD.PhD, 0577-88002888, liting1021@aliyun.com
About this study
Official title: Elderly Patients Undergoing Surgery During Perioperative Period: a Prospective Cohort Study
The elderly patients have poorer overall conditions and have lower tolerance to trauma, anesthesia, and surgery. Therefore, the incidence of postoperative complications is relatively higher. In non-cardiac surgeries, approximately 20% of elderly patients experience postoperative complications, and the incidence of postoperative delirium (POD) is 23.8%. This may lead to prolonged hospital stays, increased hospital costs, and affect prognosis and even mortality. The investigators plan to conduct a prospective cohort study by systematically collecting biological samples and clinical information of elderly patients during the perioperative period to explore the possible risk factors and pathogenesis of postoperative delirium and postoperative complications in elderly surgical patients, and to construct a risk prediction model for postoperative complications.
- Conditions
- Postoperative Complications, Elderly, Postoperative Delirium (POD), Risk Prediction Model, Pathogenesis
- Keywords
- postoperative delirium, elderly, Cohort study
- Medical subject headings
- Postoperative Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients aged 65 years or older | For the surgical group patients, questionnaires and scales measuring cognitive function, sleep quality, and quality of life were collected preoperatively, at 1-7 days post-operation, 30 days post-operation, and 1 year post-operation. During the operation, blood, cerebrospinal fluid, and other biological samples from the patients were also collected. | |
| non-surgical subjects aged 65 years or older | For the non-surgical group patients, patients' basic information was collected, along with cognitive scales, sleep scales, and quality of life questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium (POD) within 7 days after surgery
POD is diagnosed daily using the Three-Minute Diagnostic Confusion Assessment Method (3D-CAM).
Measured: Preoperative, during the first 7 postoperative days
Secondary outcomes (14)
The types of postoperative delirium
The type of delirium is assessed using the Richmond Agitation-Sedation Scale (RASS). The Richmond Agitation-Sedation Scale (RASS) is a 10-point scale ranging from -5 (unarousable) to +4 (combative). A score of +4 represents a combative state where the patient is violent and poses immediate danger, while a score of -5 indicates no response to any stimulus. Based on the RASS score, delirium can be categorized into three motoric subtypes: Hyperactive delirium: RASS scores consistently between +1 and +4. Hypoactive delirium: RASS scores consistently between 0 and -3. Mixed-type delirium: RASS scores that fluctuate between positive and negative values over the observation period.
Measured: Preoperative, during the first 7 postoperative days
The severity of postoperative delirium
The severity of postoperative delirium will be assessed using the Confusion Assessment Method-Severity scale (CAM-S).
Measured: Preoperative, during the first 7 postoperative days
The duration of postoperative delirium
Duration is defined as the number of days from the onset of delirium symptoms to symptom resolution or hospital discharge, whichever occurs first.
Measured: Preoperative, during the first 7 postoperative days
Postoperative neurocognitive dysfunction
Neurocognitive decline is assessed by comparing baseline to postoperative scores on: Mini-Mental State Examination (MMSE, 0-30, higher=better function), Montreal Cognitive Assessment (MoCA, 0-30, higher=better function); and five neuropsychological tests-Clock Drawing Test, (DST, 0-16, higher=better attention), Trail Making Test Parts A and B (TMT-A/B, seconds, lower=better), Boston Naming Test (BNT, 0-30, higher=better naming), Auditory Verbal Learning Test - Huashan version (AVLT-H delayed recall, 0-10, higher=better memory), and Clock Drawing Test (CDT, 0-10, higher=better visuospatial/executive function). Patient/caregiver reports are also collected.
Measured: preoperative baseline, within 7 days postoperatively, and at 1, 6, and 12 months postoperatively.
Acute pain
Using Visual Analogue Scale (VAS), 0-100, 0 means no pain, 100 means severe pain
Measured: Preoperative and 3 days postoperative.
Hospital Anxiety and Depression Scale (HADS) score
The Hospital Anxiety and Depression Scale (HADS) is used for assessment, with each subscale (anxiety or depression) scored from 0-21: "0-7: Non-case", "8-10: Doubtful case", "11-21: Definite case". Higher scores clearly indicate worse outcomes, i.e., more severe anxiety or depression symptoms.
Measured: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.
Activity of Daily Living
The Activities of Daily Living (ADL) are typically assessed using the Barthel Index. 0-100. A higher score indicates stronger independence: a score of 100 represents complete independence; a score of 61-99 suggests mild functional impairment with basic self-care ability; and a score of ≤40 indicates severe functional impairment, with significant or complete reliance on others for daily living.
Measured: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.
Sleep quality
Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 points. A score greater than 7 (>7) is typically considered the clinical cutoff for poor sleep quality. A higher score indicates poorer sleep quality.
Measured: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.
The FRAIL Scale
The FRAIL (Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight) Scale ranges from 0 to 5. A score of 0 indicates robust/non-frail status, scores of 1-2 indicate pre-frail status, and scores of 3-5 indicate frail status.
Measured: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.
Quality of Life Score
using EQ-5D(Score of EuroQol Five Dimensions Questionnaire (EQ-5D)) to measure quality of life
Measured: preoperative, 1 month, 6 months, and 1 year postoperative.
Mortality
In-hospital mortality; 30-day postoperative mortality; 1-year postoperative mortality
Measured: During hospitalization, 1 month, 6 months, and 1 year postoperative.
Length of hospitalization
Length of hospital stay are measured from the anesthesia starting day to the discharge day
Measured: till the day of discharge from hospital, an average of 7 days
Days at home up to 30 days after surgery (DAH30)
Measured: up to 30 days after surgery
Economic indicators
Hospitalization fees; -Preoperative fees; -Anesthesia fees; -Surgery fees; -Post-operative fees; -Post-discharge medical expenses.
Measured: during the entire trial, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start30 Dec 2023
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- 1,200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Li, Second Affiliated Hospital of Wenzhou Medical University
- Investigators
- Ting Li, MD. PhD, Principal investigator, Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314762
- Sponsor's protocol ID
- SAHoWMU-CR2025-03-231
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderly Patients Undergoing Surgery During Perioperative Period: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07314762
- Acronym / sponsor ID
- SAHoWMU-CR2025-03-231
- Conditions
- Postoperative Complications, Elderly, Postoperative Delirium (POD), Risk Prediction Model, Pathogenesis
- Keywords
- postoperative delirium, elderly, Cohort study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 2 Jan 2026 (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.
The elderly patients have poorer overall conditions and have lower tolerance to trauma, anesthesia, and surgery. Therefore, the incidence of postoperative complications is relatively higher. In non-cardiac surgeries, approximately 20% of elderly patients experience postoperative complications, and the incidence of postoperative delirium (POD) is 23.8%. This may lead to prolonged hospital stays, increased hospital costs, and affect prognosis and even mortality. The investigators plan to conduct a prospective cohort study by systematically collecting biological samples and clinical information of elderly patients during the perioperative period to explore the possible risk factors and pathogenesis of postoperative delirium and postoperative complications in elderly surgical patients, and to construct a risk prediction model for postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical patients aged 65 years or older | – | –For the surgical group patients, questionnaires and scales measuring cognitive function, sleep quality, and quality of life were collected preoperatively, at 1-7 days post-operation, 30 days post-operation, and 1 year post-operation. During the operation, blood, cerebrospinal fluid, and other biological samples from the patients were also collected. |
| non-surgical subjects aged 65 years or older | – | –For the non-surgical group patients, patients' basic information was collected, along with cognitive scales, sleep scales, and quality of life questionnaires. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Surgical patients aged 65 or above or non-surgical subjects aged 65 or above
Key inclusion criteria (1 listed)
- 1) Surgical patients aged 65 or above or non-surgical subjects aged 65 or above. 2) Agree to participate in this study and sign the informed consent form.
Key exclusion criteria (1 listed)
- 1）Refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative delirium (POD) within 7 days after surgery
Time frame: Preoperative, during the first 7 postoperative days
POD is diagnosed daily using the Three-Minute Diagnostic Confusion Assessment Method (3D-CAM).
14 secondary outcomes
The types of postoperative delirium
Time frame: Preoperative, during the first 7 postoperative days
The severity of postoperative delirium
Time frame: Preoperative, during the first 7 postoperative days
The duration of postoperative delirium
Time frame: Preoperative, during the first 7 postoperative days
Postoperative neurocognitive dysfunction
Time frame: preoperative baseline, within 7 days postoperatively, and at 1, 6, and 12 months postoperatively.
Acute pain
Time frame: Preoperative and 3 days postoperative.
Hospital Anxiety and Depression Scale (HADS) score
Time frame: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.
Activity of Daily Living
Time frame: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.
Sleep quality
Time frame: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.
The FRAIL Scale
Time frame: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.
Quality of Life Score
Time frame: preoperative, 1 month, 6 months, and 1 year postoperative.
Mortality
Time frame: During hospitalization, 1 month, 6 months, and 1 year postoperative.
Length of hospitalization
Time frame: till the day of discharge from hospital, an average of 7 days
Days at home up to 30 days after surgery (DAH30)
Time frame: up to 30 days after surgery
Economic indicators
Time frame: during the entire trial, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan.
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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.
Ting Li, MD. PhD principal investigator
Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
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 Postoperative Complications and Elderly, run by Second Affiliated Hospital of Wenzhou Medical University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Li MD. PhD (+86-135-8787-6896, liting1021@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (POD) within 7 days after surgery (time frame: Preoperative, during the first 7 postoperative days). 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 1 Apr 2026.