Status:
RECRUITING
A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Thyroid Lobectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Detailed Description
Primary Objective: --To determine whether same-day discharge is non-inferior to usual care (overnight stay) with regard to the MD Anderson Symptom Inventory - Thyroid (MDASI-Thyroid) mean severity sc...
Eligibility Criteria
Inclusion
- Patients ≥18 years of age
- Patients undergoing initial partial or complete thyroid lobectomy
- English and non-English speaking patients are eligible
Exclusion
- 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
Key Trial Info
Start Date :
November 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06085625
Start Date
November 26 2024
End Date
November 1 2027
Last Update
November 13 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030