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NCT06085625 | NOT YET RECRUITING | Thyroid Lobectomy

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

M.D. Anderson Cancer Center

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

Condition or disease

Thyroid Lobectomy

Intervention/treatment

Pre-Surgery Survey

Post-Surgery Surveys

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 224 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy
Actual Study Start Date : 2025-04-30
Estimated Primary Completion Date : 2025-11-01
Estimated Study Completion Date : 2027-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy

Location Details

NCT06085625

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030