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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Pre-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.
• Поведенческое Post-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 p

Первичные конечные точки

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [Срок оценки: through study completion; an average of 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06085625 · 2022-0511 · NCI-2023-08793

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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