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Telemedicine for Postoperative Follow-up After Oncological Surgeries

Telemedicine for Postoperative Follow-up After Oncological Surgeries

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06282354
Enrollment
200
Registered
2024-02-28
Start date
2024-03-01
Completion date
2025-02-15
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Adhesion, Satisfaction, Patient, Surgery, Urologic Cancer

Brief summary

The study will be a prospective, randomized, non-inferiority, open-label study, to be carried out at the Cancer Institute of the State of São Paulo for 6 months and will include patients agreeing to voluntary participation upon signing an informed consent form.

Detailed description

All patients with urological neoplasms who have undergone low and medium complexity surgical procedures (e.g. prostate TUR, Bladder TURP, double-J passage, partial or total videolaparoscopic and open nephrectomies) at ICESP will be invited to participate. It will be excluded all patients undergoing emergency operations, outpatient procedures, major procedures, patients with probes or drains or no support for home telemedicine.A telemedicine platform for video conferencing will be used by the healthcare team at our institution. The information from the patient will be protected by security passwords following ethical and legal provisions. The patient will be invited to participate in the study at the preoperative evaluation. If it agrees to participate, it will sign the agreement informed consent, and will be randomized in the Redcap® software to one of the study arms (post-operative consultations in person or telemedicine). Patient follow-up in the study will be carried out with the first post-surgery visit between 10 - 20 days after discharge, according to the type of consultation for which the patient was randomized pre-surgery. The main outcome assessed will be the degree of patient satisfaction assessed by using a Likert scale. For patients randomized to the telemedicine arm, the global perception of satisfaction in all aspects of the teleconsultation will be quantified through a Patient Satisfaction Assessment questionnaire served via telemedicine. It will also be evaluated the perception of security defined as security of personal information (Laws General Data Protection - LGPD) . For patients randomized to the in-person postoperative consultations arm, it will be applied an adapted questionnaire, based on QAS-Tele, in order to verify the degree of patient satisfaction in relation to their type of consultation and their interest in carrying out telemedicine consultations in the future. Questionnaires will be administered to patients 5 to 10 days after the first post-operative return to evaluate the issues mentioned by members of the research team via telephone contact. In addition to this information, patients coming to the institution's emergency room will be quantified within a period of up to 30 days after surgery. The secondary outcomes will be the number of unattended arrivals programmed at the institution, presence of postoperative complications graded according to the Clavien-Dindo classification, appointment's duration, number of exams requested by the attending physicians, total cost involved per service (expenses with travel, mobile internet data package, necessary structure to telemedicine services) and environmental impact generated with both types of services. Patients will have their demographic data and clinical conditions recorded in appropriate database using RedCap software (Sex, Age, index of body mass, classification of the American Society of Anesthesiologists, Charlson classification, Clavien-Dindo classification). The descriptive analysis will be made by reporting the quantitative variables through the mean, standard deviation, median and quartile, and statistical analysis performed using the Wilcoxon-Mann-Whitney.

Interventions

OTHERType of post-operative appointment

remote post-operative appointment for small or medium urooncology procedures

Sponsors

Instituto do Cancer do Estado de São Paulo
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* All patients with urological neoplasms who have undergone low and medium complexity surgical procedures (e.g. prostate TUR, Bladder TURP, double-J passage, partial or total nephrectomy videolaparoscopic and open) at ICESP

Exclusion criteria

* All patients undergoing emergency operations, outpatient procedures, major procedures, patients with probes or drains or no support for home telemedicine

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction in the post-operative return10 - 20 days after the surgical procedureDegree of patient satisfaction assessed by using a Likert scale with seven questions about the appointment quality and grading with five answers (definitely not, probably not, maybe, probably yes, definitely yes)

Secondary

MeasureTime frameDescription
Postoperative complications30 daysPresence of postoperative complications graded according to the Clavien-Dindo classification
Appointment's time30 daysDuration of the appointment
unattended arrivals at the institution30 daysNumber of unattended arrivals at the institution or emergency services
Total cost involved per service10 - 20 daysExpenses with travel, mobile internet data package, necessary structure to telemedicine services
Environmental impact10 - 20 daysEnvironmental impact in the follow-up measured by carbon dioxide emission produced by the type of transportation and travel time.
Number of exams requested10 - 20 daysNumber of exams requested by the attending physicians in the post-operative return

Contacts

Primary ContactRomulo Nunes, MD
romulo.nunes@hc.fm.usp.br+5511993793531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026