Clinical trial NCT06085625: A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy
Official title: A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Thyroid Lobectomy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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: 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

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Paul Graham, M D
role: PRINCIPAL_INVESTIGATOR
References: