Comparing same-day discharge to overnight observation after thyroid surgery
A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy
This study is testing if patients can safely go home the same day after thyroid surgery instead of staying overnight, while checking how they feel and any complications they might have.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06085625 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and patient-reported outcomes of same-day discharge versus overnight observation following thyroid lobectomy. The primary objective is to determine if same-day discharge is non-inferior to the traditional overnight stay in terms of symptom severity as measured by the MD Anderson Symptom Inventory - Thyroid at two weeks post-procedure. Secondary objectives include assessing differences in post-operative complications, pain management, and resource utilization between the two discharge practices. The study will involve pre-surgery and post-surgery surveys to gather comprehensive data on patient experiences and outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing their first partial or complete thyroid lobectomy.
Not a fit: Patients with increased risk of bleeding, significant comorbidities, or those living far from the hospital may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient discharge practices, improving patient satisfaction and reducing healthcare costs.
How similar studies have performed: Other studies have shown promising results with same-day discharge protocols in various surgical settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Paul Graham, M D — M.D. Anderson Cancer Center
- Study coordinator: Paul Graham, M D
- Email: phgraham@mdanderson.org
- Phone: (832) 829-2547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.