Visceral Surgery ComplicationsNCT06624995
Chatbot on the Prevention of Postoperative Complications
A study testing chatbot education in people with Visceral Surgery Complications, run by Mansoura University.
Trial summary
Major visceral surgery encompasses a broad range of operations with a wide variety of procedures that fall under this category. The majority of patients undergoing major visceral surgery often present with cancer and other medical comorbidities and are put at an elevated risk of a large number of medical and surgical… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Visceral Surgery Complications
- What is being tested?
- chatbot education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Apr 2025
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 60 years old and above, both sex, scheduled for elective major visceral surgery, able to communicate in the local language, and without any cognitive impairment.
Who cannot join
- Elderly patients with a history of major psychiatric disorders, patients with a history of previous major visceral surgery, and patients who were unable to provide informed consent will be excluded from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Traditional Nurse-led Education and Chatbot on the Prevention of Postoperative Complications After Major Visceral Surgery: a Randomized Controlled Trial
Major visceral surgery encompasses a broad range of operations with a wide variety of procedures that fall under this category. The majority of patients undergoing major visceral surgery often present with cancer and other medical comorbidities and are put at an elevated risk of a large number of medical and surgical postoperative complications
Read the detailed description
Complications following major visceral surgery are relatively common and are estimated to occur in 18-23% of patients . The management of complications is challenging for both the elderly patient and the perioperative team, and adds considerably to the cost of care particularly when further interventions involve readmission, unplanned admission to an intensive care unit, interventional radiology and/or an unplanned return to theatre. With the advancement of online patient portals, the use of internet to seek for health information is already a common phenomenon; Chatbot may become a more significant source of information for patients.
- Conditions
- Visceral Surgery Complications
- Being tested
- chatbot education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chatbot educationOther
elderly patients interacted with Chatbot to discuss general postoperative complication related inquiries
| Study group | Role | What they receive |
|---|---|---|
| traditional nurse-led education | No intervention | Not described |
| chatbot education | Experimental | Not described Receives: Other: chatbot education |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morbidity
using the postoperative morbidity survey , Patients are assessed for diagnostic features in nine domains (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological, wound and pain). For each of the nine domains morbidity is recorded on the presence or absence of preset criteria and it appears to accurately describe the pattern and prevalence of morbidity in the postoperative setting. I
Measured: patient will be evaluated at three time points: 24 hour postoperative; 48 hours postoperative , and 30 days postoperative.
Secondary outcomes (3)
Geriatric anxiety
questionnaire comprising 30 items, called the GAS was created to evaluate, screen for, and quantify the intensity of anxiety symptoms in older persons
Measured: will be measured at three time points: 90 to 120 minutes before the preoperative consultation (baseline ); after 7 days postoperative, and after 30 days postoperative
quality of life
This short version of the SF-36 tool consists of 12 items and eight scales: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and perceived mental health (MH).
Measured: will be measured at two time points : at baseline (preoperative ) and after 30 days postoperative
usability of using chatbots
This scale was composed of 16 validated items aimed to assess the personality, onboarding, navigation, understanding, responses, error handling and intelligence of a chatbot.
Measured: 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (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 Visceral Surgery ComplicationsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed elsayed hamed elzeky, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624995
- Sponsor's protocol ID
- 0637
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elzeky MEH, Ali SM, Alanazi S, Shoukr EMM, Shahine NFM. Traditional nurse-led vs chatbot education for older adults in postoperative complication prevention after major visceral surgery: A randomized controlled trial. Geriatr Nurs. 2026 Jun 28;72:104166. doi: 10.1016/j.gerinurse.2026.104166. Online ahead of print.
PubMed 42365771
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Traditional Nurse-led Education and Chatbot on the Prevention of Postoperative Complications After Major Visceral Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06624995
- Acronym / sponsor ID
- 0637
- Conditions
- Visceral Surgery Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 3 Oct 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.
Major visceral surgery encompasses a broad range of operations with a wide variety of procedures that fall under this category. The majority of patients undergoing major visceral surgery often present with cancer and other medical comorbidities and are put at an elevated risk of a large number of medical and surgical postoperative complications
Detailed description
Complications following major visceral surgery are relatively common and are estimated to occur in 18-23% of patients . The management of complications is challenging for both the elderly patient and the perioperative team, and adds considerably to the cost of care particularly when further interventions involve readmission, unplanned admission to an intensive care unit, interventional radiology and/or an unplanned return to theatre. With the advancement of online patient portals, the use of internet to seek for health information is already a common phenomenon; Chatbot may become a more significant source of information for patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional nurse-led education | No intervention | – |
| chatbot education | Experimental | Other: chatbot education |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 60 years old and above, both sex, scheduled for elective major visceral surgery, able to communicate in the local language, and without any cognitive impairment.
Key exclusion criteria (1 listed)
- Elderly patients with a history of major psychiatric disorders, patients with a history of previous major visceral surgery, and patients who were unable to provide informed consent will be excluded from 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chatbot educationelderly patients interacted with Chatbot to discuss general postoperative complication related inquiries | Other | chatbot education |
Primary outcome
postoperative morbidity
Time frame: patient will be evaluated at three time points: 24 hour postoperative; 48 hours postoperative , and 30 days postoperative.
using the postoperative morbidity survey , Patients are assessed for diagnostic features in nine domains (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological, wound and pain). For each of the nine domains morbidity is recorded on the presence or absence of preset criteria and it appears to accurately describe the pattern and prevalence of morbidity in the postoperative setting. I
3 secondary outcomes
Geriatric anxiety
Time frame: will be measured at three time points: 90 to 120 minutes before the preoperative consultation (baseline ); after 7 days postoperative, and after 30 days postoperative
quality of life
Time frame: will be measured at two time points : at baseline (preoperative ) and after 30 days postoperative
usability of using chatbots
Time frame: 4 weeks postoperatively
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 16 Oct 2024.
- Derived from this study: PubMed 42365771Elzeky MEH, Ali SM, Alanazi S, Shoukr EMM, Shahine NFM. Traditional nurse-led vs chatbot education for older adults in postoperative complication prevention after major visceral surgery: A randomized controlled trial. Geriatr Nurs. 2026 Jun 28;72:104166. doi: 10.1016/j.gerinurse.2026.104166. Online ahead of print.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing chatbot education in people with Visceral Surgery Complications, run by Mansoura University.
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: opening soon, as of the sponsor's last update on 16 Oct 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?
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 mohamed hamed elzeky, phd (+201040627871, mohamadelzeky@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative morbidity (time frame: patient will be evaluated at three time points: 24 hour postoperative; 48 hours postoperative , and 30 days postoperative.). 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 NCT06624995, 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 16 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.