RecruitingPhase 2NCT06085625

A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy


Sponsor

M.D. Anderson Cancer Center

Enrollment

224 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To compare same-day discharge and overnight (or longer) observation practices and learn more about the differences in patient preferences, safety outcomes, and economic and resource impact


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients ≥18 years of age
  • Patients undergoing initial partial or complete thyroid lobectomy
  • English and non-English speaking patients are eligible

Exclusion Criteria5

  • Increased risk of bleeding (e.g., Aspirin, antiplatelet therapy, or anticoagulation that cannot be held 5 days before surgery, baseline thrombocytopenia <50,000/µL)
  • Pre-existing medical comorbidities or poor performance status (Eastern Cooperative Oncology Group performance status >2) that would otherwise dictate overnight in-hospital postoperative observation
  • Increased distance of residence from index hospital (>50 miles) or inability to stay within the targeted area (<50 miles) postoperatively prohibiting timely return to the index hospital in emergent situations
  • Lives alone or unable to independently perform Activities of Daily Living and no available caregiver in the immediate postoperative period (POD 0-3)
  • Pregnant women will not be included in this study

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Interventions

BEHAVIORALPre-Surgery Survey

Participants will be asked to complete a survey 3 times (before surgery, after surgery, and 2 weeks after surgery). You will be monitored for up to 1 month after your surgery, where you may be contacted by a study provider virtually or in person to ask you about medication usage and heath care needs.

BEHAVIORALPost-Surgery Surveys

After surgery, Participants will complete the same survey as in the pre-surgery visit about 1 day and then 2 weeks after surgery. These surveys will be completed electronically through the MyChart system. They will take about 5-10 minutes to complete and must be done within 24 hours after receiving the survey. Participants will be monitored for 1 month after your surgery, including your standard-of-care postoperative visit at about 2 weeks. You may be contacted by a provider for a phone or in person visit at the 1-month time point to ask how you are doing.


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT06085625