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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥18 years of age

Patients undergoing initial partial or complete thyroid lobectomy

English and non-English speaking patients are eligible

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Pre-Surgery Survey

    Behavioral

    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.

  • Post-Surgery Surveys

    Behavioral

    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 person visit at the 1-month time point to ask how you are doing.

Treatment groups

224 Participants
are divided into 1 treatment group
Group A: Patient Reported Outcomes and Safety in Outpatient Thyroid LobectomyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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