NCT06085625PHASE2Recruiting

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

M.D. Anderson Cancer Center

Start Date

11/26/2024

Completion Date

11/1/2027

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 score, as assessed at 2 weeks post-procedure in patients undergoing thyroid lobectomy. Secondary Objectives: * To determine whether same-day discharge is non-inferior to usual care (overnight stay) with regard to the MDASI-Thyroid mean severity score, as assessed at 24 hours post-procedure in patients undergoing thyroid lobectomy. * To determine whether the two arms differ by incidence of deviations from normal as defined by post-operative hematoma, emergency care presentation, readmission/re-intervention, high pain severity scores, and 30-day mortality. * To determine whether morphine milligram equivalents (MME) used over the 2-week post-operative period differs between patients who receive same-day discharge vs. those who receive usual care (overnight stay) after receiving thyroid lobectomy.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Patients ≥18 years of age 2. Patients undergoing initial partial or complete thyroid lobectomy 3. English and non-English speaking patients are eligible Exclusion Criteria: 1. Increased risk of bleeding (e.g., Aspirin, antiplatelet therapy, or anticoagulation that cannot be held 5 days before surgery, baseline thrombocytopenia \<50,000/µL) 2. Pre-existing medical comorbidities or poor performance status (Eastern Cooperative Oncology Group performance status \>2) that would otherwise dictate overnight in-hospital postoperative observation 3. 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 4. Lives alone or unable to independently perform Activities of Daily Living and no available caregiver in the immediate postoperative period (POD 0-3) 5. Pregnant women will not be included in this study

Interventions

BEHAVIORAL

Pre-Surgery Survey

BEHAVIORAL

Post-Surgery Surveys

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Conditions

Thyroid Lobectomy

Locations

M D Anderson Cancer Center

Houston, Texas 77030

United States