Telemedicine for Postoperative Follow-up After Oncological Surgeries

Surgery Clinical Trial

Official title:

Telemedicine for Postoperative Follow-up After Oncological Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06282354
• Other study ID #: NP4035/2023
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: February 15, 2025

Study information

• Verified date: January 2024
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Romulo Nunes, MD
• Phone: +5511993793531
• Email: romulo.nunes[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 15, 2025
• Est. primary completion date: August 15, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Adhesion
• Satisfaction, Patient
• Surgery
• Urologic Cancer
• Urologic Neoplasms

Intervention

Other:
• Type of post-operative appointment
remote post-operative appointment for small or medium urooncology procedures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

References & Publications (9)

Committee on Improving the Quality of Cancer Care: Addressing the Challenges of an Aging Population; Board on Health Care Services; Institute of Medicine; Levit L, Balogh E, Nass S, Ganz PA, editors. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. Washington (DC): National Academies Press (US); 2013 Dec 27. Available from http://www.ncbi.nlm.nih.gov/books/NBK202148/ — View Citation

Heymann DL, Shindo N; WHO Scientific and Technical Advisory Group for Infectious Hazards. COVID-19: what is next for public health? Lancet. 2020 Feb 22;395(10224):542-545. doi: 10.1016/S0140-6736(20)30374-3. Epub 2020 Feb 13. No abstract available. — View Citation

Kummerow Broman K, Roumie CL, Stewart MK, Castellanos JA, Tarpley JL, Dittus RS, Pierce RA. Implementation of a Telephone Postoperative Clinic in an Integrated Health System. J Am Coll Surg. 2016 Oct;223(4):644-51. doi: 10.1016/j.jamcollsurg.2016.07.010. Epub 2016 Aug 18. — View Citation

Lerner AM, Folkers GK, Fauci AS. Preventing the Spread of SARS-CoV-2 With Masks and Other "Low-tech" Interventions. JAMA. 2020 Nov 17;324(19):1935-1936. doi: 10.1001/jama.2020.21946. No abstract available. — View Citation

Loeb AE, Rao SS, Ficke JR, Morris CD, Riley LH 3rd, Levin AS. Departmental Experience and Lessons Learned With Accelerated Introduction of Telemedicine During the COVID-19 Crisis. J Am Acad Orthop Surg. 2020 Jun 1;28(11):e469-e476. doi: 10.5435/JAAOS-D-20-00380. — View Citation

Moreira TC, Constant HM, Faria AG, Matzenbacher AMF, Balardin GU, Matturro L, Silva MS, Umpierre RN, Rodrigues AS, Cabral FC, Pagano CGM. Tradução, adaptação transcultural e validação de questionário de satisfação em telemedicina. Rev Bras Med Fam Comunidade. 2022;17(44):2837.

Nikolian VC, Williams AM, Jacobs BN, Kemp MT, Wilson JK, Mulholland MW, Alam HB. Pilot Study to Evaluate the Safety, Feasibility, and Financial Implications of a Postoperative Telemedicine Program. Ann Surg. 2018 Oct;268(4):700-707. doi: 10.1097/SLA.0000000000002931. — View Citation

Ohannessian R, Duong TA, Odone A. Global Telemedicine Implementation and Integration Within Health Systems to Fight the COVID-19 Pandemic: A Call to Action. JMIR Public Health Surveill. 2020 Apr 2;6(2):e18810. doi: 10.2196/18810. — View Citation

Walker J, Fleece ME, Griffin RL, Leal SM, Alsip JA, Stigler WS, Nafziger SD, Marrazzo JM, Lee RA. Decreasing High-risk Exposures for Healthcare Workers Through Universal Masking and Universal Severe Acute Respiratory Syndrome Coronavirus 2 Testing on Entry to a Tertiary Care Facility. Clin Infect Dis. 2021 Nov 2;73(9):e3113-e3115. doi: 10.1093/cid/ciaa1358. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction in the post-operative return	Degree 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)	10 - 20 days after the surgical procedure
Secondary	unattended arrivals at the institution	Number of unattended arrivals at the institution or emergency services	30 days
Secondary	Postoperative complications	Presence of postoperative complications graded according to the Clavien-Dindo classification	30 days
Secondary	Appointment's time	Duration of the appointment	30 days
Secondary	Number of exams requested	Number of exams requested by the attending physicians in the post-operative return	10 - 20 days
Secondary	Total cost involved per service	Expenses with travel, mobile internet data package, necessary structure to telemedicine services	10 - 20 days
Secondary	Environmental impact	Environmental impact in the follow-up measured by carbon dioxide emission produced by the type of transportation and travel time.	10 - 20 days