Telemedicine for Postoperative Follow-up After Oncological Surgeries
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2025
CompletedFebruary 28, 2024
January 1, 2024
6 months
January 19, 2024
February 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
unattended arrivals at the institution
30 days
Postoperative complications
30 days
Appointment's time
30 days
Number of exams requested
10 - 20 days
Total cost involved per service
10 - 20 days
- +1 more secondary outcomes
Study Arms (2)
Face-to-face appointment
Patients allocated in face-to-face appointment after urooncologic surgical procedures
Telemedicine appointment
Patients allocated in telemedicine appointment after urooncologic surgical procedures
Interventions
remote post-operative appointment for small or medium urooncology procedures
Eligibility Criteria
Oncologic patients from the ICESP
You may qualify if:
- 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
You may not qualify if:
- All patients undergoing emergency operations, outpatient procedures, major procedures, patients with probes or drains or no support for home telemedicine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (9)
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.
PMID: 32061313BACKGROUNDLerner 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.
PMID: 33104157BACKGROUNDWalker 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.
PMID: 32901247BACKGROUNDLoeb 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.
PMID: 32301818BACKGROUNDOhannessian 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.
PMID: 32238336BACKGROUNDCommittee 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/
PMID: 24872984BACKGROUNDKummerow 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.
PMID: 27545100BACKGROUNDNikolian 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.
PMID: 30095477BACKGROUNDMoreira 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2024
First Posted
February 28, 2024
Study Start
March 1, 2024
Primary Completion
August 15, 2024
Study Completion
February 15, 2025
Last Updated
February 28, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share