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

Conditions

• Thyroid Lobectomy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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

Key Dates

Start date

Nov 26, 2024

Status verified

May 2026

Primary completion

Nov 1, 2027

Completion

Nov 1, 2027

Study Design

Enrollment

224 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy
  Participants will first complete a survey about the severity of your symptoms. This will be done at your pre-surgery (pre-operative) visit and should take about 5-10 minutes to complete. Study Groups At your pre-surgery visit, you will be assigned to either be sent home on the same day as surgery or to stay in the hospital overnight (or longer) for observation. This will be determined based on which group your surgeon has been assigned to. Participants will be told which group you are in.

Primary Outcome Measure

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 ]

Central Contacts

• Paul Graham, M D
  (832) 829-2547
  [email protected]

Locations (1)

Find similar trials in Houston, TX