Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery
NCT ID: NCT04235803
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2021-07-01
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Telemedicine
Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.
Telemedicine follow-up
A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.
Routine
Patient in the routine arm will have their post-operative week one visit in clinic.
No interventions assigned to this group
Interventions
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Telemedicine follow-up
A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.
Eligibility Criteria
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Inclusion Criteria
* Are fluent in English
* Own or have ready access to a smart phone, tablet, or personal computer with high speed internet
* Participate in an informed consent process with the surgeon(s) including documentation of written informed consent
* Are undergoing a low-risk\* eyelid procedure in a clinic, ambulatory surgery center, or hospital operating room setting, including but not limited to:
* upper eyelid blepharoplasty repair
* ectropion repair
* entropion repair
* external levator resection
* internal levator resection
* eyelid lesion removal and/or biopsy
* eyelid reconstruction and defect repair including after Mohs' surgery
* eyelid tightening procedures for Floppy Eyelid Syndrome
* tarsorrhaphy
* dacryocystorhinostomy
(\*)These listed procedures have a low reported rate of serious complications including vision loss, infection, severe bleeding, or death; however, surgical risk is ultimately determined by the surgeon on a per-patient basis, except in those cases specifically excluded in the subsequent section.
Exclusion Criteria
* Are incarcerated
* Are pregnant or plan to become pregnant during the period of surgery and 3 month recovery (however these patients are not eligible for elective eyelid surgery)
* Are not fluent in English
* Do not have access to or do not feel comfortable using a smart phone, tablet, or personal computer
* Lack personal capacity for consent (i.e. those patients requiring consent for the surgery by a legal representative are excluded)
* Experience a serious intra-operative complication (this criterion is assessed after initial consent)
* Are undergoing eyelid or other oculoplastic procedures that are deemed greater than low-risk for serious complications, including but not limited to:
* orbital surgery
* lower eyelid blepharoplasty
* repair of extensive eyelid defects following Mohs' surgery (roughly \>33%)
* procedures requiring skin grafting
* procedures requiring extensive tissue rearrangement
* procedures involving an implant (e.g. frontalis sling, gold weight implantation; except dacryocystorhinostomy due to the low-risk nature of the lacrimal stent)
* procedures requiring in-person care at the first post-operative week (e.g. suture removal, bolster removal, patch removal)
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Davin C Ashraf, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Vyas KS, Hambrick HR, Shakir A, Morrison SD, Tran DC, Pearson K, Vasconez HC, Mardini S, Gosman AA, Dobke M, Granick MS. A Systematic Review of the Use of Telemedicine in Plastic and Reconstructive Surgery and Dermatology. Ann Plast Surg. 2017 Jun;78(6):736-768. doi: 10.1097/SAP.0000000000001044.
Hwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672.
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.
Robaldo A, Rousas N, Pane B, Spinella G, Palombo D. Telemedicine in vascular surgery: clinical experience in a single centre. J Telemed Telecare. 2010;16(7):374-7. doi: 10.1258/jtt.2010.091011. Epub 2010 Aug 2.
Williams AM, Bhatti UF, Alam HB, Nikolian VC. The role of telemedicine in postoperative care. Mhealth. 2018 May 2;4:11. doi: 10.21037/mhealth.2018.04.03. eCollection 2018.
Carter SR, Stewart JM, Khan J, Archer KF, Holds JB, Seiff SR, Dailey RA. Infection after blepharoplasty with and without carbon dioxide laser resurfacing. Ophthalmology. 2003 Jul;110(7):1430-2. doi: 10.1016/S0161-6420(03)00447-0.
Chang S, Lehrman C, Itani K, Rohrich RJ. A systematic review of comparison of upper eyelid involutional ptosis repair techniques: efficacy and complication rates. Plast Reconstr Surg. 2012 Jan;129(1):149-157. doi: 10.1097/PRS.0b013e318230a1c7.
Lee EW, Holtebeck AC, Harrison AR. Infection rates in outpatient eyelid surgery. Ophthalmic Plast Reconstr Surg. 2009 Mar-Apr;25(2):109-10. doi: 10.1097/IOP.0b013e3181994124.
Mejia JD, Egro FM, Nahai F. Visual loss after blepharoplasty: incidence, management, and preventive measures. Aesthet Surg J. 2011 Jan;31(1):21-9. doi: 10.1177/1090820X10391212.
Kam KY, Cole CJ, Bunce C, Watson MP, Kamal D, Olver JM. The lateral tarsal strip in ectropion surgery: is it effective when performed in isolation? Eye (Lond). 2012 Jun;26(6):827-32. doi: 10.1038/eye.2012.34. Epub 2012 Mar 9.
Other Identifiers
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Eye plastic telemedicine
Identifier Type: -
Identifier Source: org_study_id