Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06085625

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Paul Graham, M D

CONTACT

[email protected]

832-829-2547

Paul Graham, M D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Graham, M D

CONTACT

[email protected]

(832) 829-2547

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 17, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.