Elective Major Abdominal SurgeryPANDAMANNCT06182215
PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)
An observational study of Elective Major Abdominal Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Predisposing and precipitating factors for perioperative delirium for the elderly remain elusive. This research will be conducted to determine risk factors of postoperative delirium. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Elective Major Abdominal Surgery
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2023to 31 Dec 2026
- How long will I take part?
- 3 Months
- 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 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 to 90 years who received elective major abdominal surgery (estimated operation time over 2 hours)
Who may be able to join
- 65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); ,
- American society of Aneshesiologists（ASA）physical status I-III;
Who cannot join
- Mini-Mental State Examination (MMES) score < 15;
- Renal failure (requiring dialysis) or liver failure (Child-Pugh score > 5);
- Severe impairment due to structural or hypoxic brain injury, more than 2 days in ICU one month before surgery;
- Underwent major heart, lung or abdominal surgery within 1 year;
- Positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or symptomatic (e.g. fever, cough, loss of taste/smell);
- The cognitive assessment cannot be completed because the subject is blind, deaf, or unable to communicate in the local language;
- Long-term follow-up unavailable (homelessness, active psychosis or substance abuse).
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 Sixth Affiliated Hospital of Sun Yet-set University
Guangzhou, Guangdong, 510100
Mengying Ding, +86-15170375679, dingmy7@mails.sysu.edu.cn
About this study
Official title: Postoperative Neurocognitive Dysfunction After Major Abdominal Surgery: A Prospective Observational Cohort Study
Predisposing and precipitating factors for perioperative delirium for the elderly remain elusive. This research will be conducted to determine risk factors of postoperative delirium.
Read the detailed description
This study intends to include 500 participants over 65 years old undergoing elective abdominal major surgery. The primary outcome is incidence of delirium at 7 days postoperatively, and the secondary outcomes include preoperative sleep disorders(Athens In-somnia Scale, AIS), postoperative cognitive impairment (Abbreviated Mental Test Score, AMTS), postoperative pain (NRS pain score), incidence of significant postoperative complications, length of hospital stay, and serum biomarkers levels.
- Conditions
- Elective Major Abdominal Surgery
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 |
|---|---|---|
| Prospective observational cohorts | patients undergoing elective major abdominal surgery (estimated operation time over 2 hours) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium during first 7 days after surgery
The result of 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) is positive.
Measured: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.
Secondary outcomes (11)
Preoperative cognitive function
The Mini-Mental State Examination scale will be used to assist in evaluating preoperative cognitive function in patients. The scale's testing items include orientation, memory, calculation, language, visual space, use, and attention, with a total score of 30. The higher the score, the better the cognitive function, and the score below 27 indicates possible cognitive impairment.
Measured: Day 1 before surgery
Age-adjusted Charlson Comorbidity Index
Age-adjusted Charlson Comorbidity Index is a method used to evaluate the impact of multiple diseases on a patient's health status. The scale includes a total of 16 common co-morbidity diseases, which is divided into 4 categories according to different disease severity, with scores of 1,2,3 or 6. The higher the score, the more kinds of diseases the patient suffers at the same time, and their health status may be more complex and fragile.
Measured: Day 1 before surgery
Preoperative anxiety
Hamilton Anxiety Scale will be used to evaluate the patient's anxiety status, which consist of 14 items. All items are scored on a 5-level scale of 0-4, with criteria for each level being none, mild, moderate, severe, and extremely severe. The higher the score, the more severe the anxiety symptoms.
Measured: Day 1 before surgery, day 3 after surgery
Serum biomakers levels
Extract venous blood samples from the target patient, store and centrifuge the Samples appropriately. Quantitatively detect the serum biomakers levels, such as NFL, using enzyme-linked immunosorbent assay, and retest the concentration changes of these biomarkers 3 days after surgery.
Measured: Within 15 minutes after induction of anesthesia, day 3 after surgery
Preoperative Sleep quality
Athens Insomnia Scale will be used to assess the patient's preoperative sleep quality. A maximum total score of 24 indicates the most severe symptoms of insomnia, while a cut-off point of ≥6 represents a minimum criterion for the confirmation of insomnia symptoms.
Measured: Day 1 before surgery, Day 3 after surgery
Postoperative pain
Postoperative pain will be evaluated by Number Rating Scale, which is composed of 11 numbers from 0 to 10, where 0 is no pain or hurt and 10 is the most or worst pain. The higher the number, the more severe the pain.
Measured: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.
Length of hospital stay
The length of patient hospital stay will be supplemented through Hospital Information System after surgery.
Measured: Up to 24 weeks after surgery
Health status and quality of life
Short Form 36 Health Survey will be used to estimate the health status and quality of life of patients. This scale includes 8 dimensions and a total of 36 questions, convert the scores of each section into a range of 0 to 100, where 100 represents the "best health state", and the lower the score, the worse the health condition.
Measured: Day 1 before surgery, day 30 after surgery
Postoperative adverse complications
Include but limited to hospital readmissions 30 days after surgery, unplaned reoperations, stroke, kidney failure, and wound infections.
Measured: Up to day 30 after surgery
All-cause mortality at 30 days after surgery
The ratio of total deaths from all causes to the population.
Measured: Up to day 30 after surgery
Postoperative cognitive dysfunction
The Abbreviated Mental Test Score will be administered by telephone respectively 1 month and 3 months after surgery to identify long-term cognitive consequences of anaesthesia and postoperative delirium. The scale consists of 10 questions with a total of 10 points, the higher the score, the better the cognitive function, and those with score < 8 will be identified as possible neurocognitive dysfunction.
Measured: Day 1 before surgery, day 30 after surgery, day 90 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start11 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Major Abdominal SurgeryStudies 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)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Xiangcai Ruan, MD, PhD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182215
- Sponsor's protocol ID
- 2023-143-v2
- Acronym
- PANDAMAN
- Status last verified
- Jun 2024
- First submitted
- 2 Dec 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen H, Ding M, Ma X, Deng W, Liang B, Ruan X, Zhang X. The multidimensional physiological, psychological, and social influencing factors of perioperative neurocognitive disorders in elderly Chinese patients undergoing major abdominal surgery: study protocol of a prospective cohort study. BMC Geriatr. 2026 Feb 2;26(1):290. doi: 10.1186/s12877-026-07052-2.
PubMed 41629790
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Neurocognitive Dysfunction After Major Abdominal Surgery: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06182215
- Acronym / sponsor ID
- PANDAMAN / 2023-143-v2
- Conditions
- Elective Major Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 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.
Predisposing and precipitating factors for perioperative delirium for the elderly remain elusive. This research will be conducted to determine risk factors of postoperative delirium.
Detailed description
This study intends to include 500 participants over 65 years old undergoing elective abdominal major surgery. The primary outcome is incidence of delirium at 7 days postoperatively, and the secondary outcomes include preoperative sleep disorders(Athens In-somnia Scale, AIS), postoperative cognitive impairment (Abbreviated Mental Test Score, AMTS), postoperative pain (NRS pain score), incidence of significant postoperative complications, length of hospital stay, and serum biomarkers levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective observational cohorts | – | –patients undergoing elective major abdominal surgery (estimated operation time over 2 hours) |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 to 90 years who received elective major abdominal surgery (estimated operation time over 2 hours)
Key inclusion criteria (2 listed)
- 65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); ,
- American society of Aneshesiologists（ASA）physical status I-III;
Key exclusion criteria (7 listed)
- Mini-Mental State Examination (MMES) score < 15;
- Renal failure (requiring dialysis) or liver failure (Child-Pugh score > 5);
- Severe impairment due to structural or hypoxic brain injury, more than 2 days in ICU one month before surgery;
- Underwent major heart, lung or abdominal surgery within 1 year;
- Positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or symptomatic (e.g. fever, cough, loss of taste/smell);
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 delirium during first 7 days after surgery
Time frame: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.
The result of 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) is positive.
11 secondary outcomes
Preoperative cognitive function
Time frame: Day 1 before surgery
Age-adjusted Charlson Comorbidity Index
Time frame: Day 1 before surgery
Preoperative anxiety
Time frame: Day 1 before surgery, day 3 after surgery
Serum biomakers levels
Time frame: Within 15 minutes after induction of anesthesia, day 3 after surgery
Preoperative Sleep quality
Time frame: Day 1 before surgery, Day 3 after surgery
Postoperative pain
Time frame: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.
Length of hospital stay
Time frame: Up to 24 weeks after surgery
Health status and quality of life
Time frame: Day 1 before surgery, day 30 after surgery
Postoperative adverse complications
Time frame: Up to day 30 after surgery
All-cause mortality at 30 days after surgery
Time frame: Up to day 30 after surgery
Postoperative cognitive dysfunction
Time frame: Day 1 before surgery, day 30 after surgery, day 90 after surgery
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 17 Jun 2024.
- Derived from this study: PubMed 41629790Chen H, Ding M, Ma X, Deng W, Liang B, Ruan X, Zhang X. The multidimensional physiological, psychological, and social influencing factors of perioperative neurocognitive disorders in elderly Chinese patients undergoing major abdominal surgery: study protocol of a prospective cohort study. BMC Geriatr. 2026 Feb 2;26(1):290. doi: 10.1186/s12877-026-07052-2.
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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.
Xiangcai Ruan, MD, PhD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen 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 Elective Major Abdominal Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen 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 2 inclusion and 7 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 17 Jun 2024. 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 Xiangcai Ruan, MD, PhD (+86-13760710099, ruanxc@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium during first 7 days after surgery (time frame: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182215, which also lists 1 linked publication.
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 17 Jun 2024.