Telemedicine for Postoperative Follow-up After Oncological Surgeries

Trial Title: Telemedicine for Postoperative Follow-up After Oncological Surgeries

NCT ID: NCT06282354

Condition: Urologic Cancer
Satisfaction, Patient
Surgery
Postoperative Adhesion

Conditions: Official terms:
Urologic Neoplasms

Study type: Observational [Patient Registry]

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Type of post-operative appointment
Description: remote post-operative appointment for small or medium urooncology procedures
Arm group label: Face-to-face appointment
Arm group label: Telemedicine appointment

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.

Criteria for eligibility:

Study pop:
Oncologic patients from the ICESP

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Start date: March 1, 2024

Completion date: February 15, 2025

Lead sponsor:
Agency: Instituto do Cancer do Estado de São Paulo
Agency class: Other

Source: Instituto do Cancer do Estado de São Paulo

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06282354