Clinical trial NCT06282354: Telemedicine for Postoperative Follow-up After Oncological Surgeries
Official title: Telemedicine for Postoperative Follow-up After Oncological Surgeries
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urologic Cancer
Satisfaction, Patient
Surgery
Postoperative Adhesion
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncologic patients from the ICESP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction in the post-operative return
timeFrame: 10 - 20 days after the surgical procedure
Secondary outcomes:
measure: unattended arrivals at the institution
timeFrame: 30 days
measure: Postoperative complications
timeFrame: 30 days
measure: Appointment's time
timeFrame: 30 days
measure: Number of exams requested
timeFrame: 10 - 20 days
measure: Total cost involved per service
timeFrame: 10 - 20 days
measure: Environmental impact
timeFrame: 10 - 20 days
Other outcomes:
Locations:
Study officials:
References:
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