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Outpatient Thyroid Lobectomy for Thyroid Disease

Phase 2

Waitlist Available

Led By Paul Graham, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥18 years of age

Patients undergoing initial partial or complete thyroid lobectomy

Must not have

Pre-existing medical comorbidities or poor performance status (Eastern Cooperative Oncology Group performance status >2) that would otherwise dictate overnight in-hospital postoperative observation

Lives alone or unable to independently perform Activities of Daily Living and no available caregiver in the immediate postoperative period (POD 0-3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to compare same-day discharge to overnight observation to learn about safety, preferences, costs, and resources.

Who is the study for?

This trial is for adults over 18 who are having their first thyroid lobectomy. It's open to both English and non-English speakers. People can't join if they have a high bleeding risk, severe health problems, live too far from the hospital, lack post-surgery support at home, or are pregnant.

What is being tested?

The study looks at whether patients prefer and do well with same-day discharge compared to staying overnight after thyroid surgery. It also examines the safety and cost differences between these two approaches using surveys before and after surgery.

What are the potential side effects?

Since this trial involves standard surgical procedures rather than testing new medications, side effects relate mainly to typical risks of thyroid surgery such as pain, infection risk, possible bleeding or nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am having part or all of one side of my thyroid removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have health conditions or a poor ability to do daily activities that require staying in the hospital after surgery.

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I live alone or can't do daily tasks by myself and have no one to help me right after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patient Reported Outcomes and Safety in Outpatient Thyroid LobectomyExperimental Treatment2 Interventions

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.

0 / 4Eligibility criteria met