NCT06624995

Brief 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 postoperative complications

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 1, 2024

Last Update Submit

October 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    patient will be evaluated at three time points: 24 hour postoperative; 48 hours postoperative , and 30 days postoperative.

Secondary Outcomes (3)

  • Geriatric anxiety

    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

    will be measured at two time points : at baseline (preoperative ) and after 30 days postoperative

  • usability of using chatbots

    4 weeks postoperatively

Study Arms (2)

traditional nurse-led education

NO INTERVENTION

chatbot education

EXPERIMENTAL
Other: chatbot education

Interventions

elderly patients interacted with Chatbot to discuss general postoperative complication related inquiries

chatbot education

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

mohamed hamed elzeky, phd

CONTACT

noha fathy shahine, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at medical surgical nursing

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

November 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share