Outpatient Thyroid Lobectomy for Thyroid Disease

Overseen By Paul Graham, M D

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Aspirin, Antiplatelet, Anticoagulation

Disqualifiers: Bleeding risk, Poor health, Distance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether patients undergoing a thyroid lobectomy (surgery to remove part of the thyroid) can safely return home the same day or if they should stay overnight in the hospital for observation. Researchers seek to understand patient preferences and how each option impacts safety and costs. Participants complete short surveys about their symptoms before (Pre-Surgery Survey) and after surgery (Post-Surgery Surveys). Suitable candidates for this trial include those undergoing a thyroid lobectomy who can manage daily activities independently and live within approximately 50 miles of the hospital. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

If you are taking medications that increase the risk of bleeding, like Aspirin or blood thinners, you will need to stop them 5 days before surgery. For other medications, the trial protocol does not specify any requirements.

What prior data suggests that this protocol is safe for outpatient thyroid lobectomy?

Research has shown that performing thyroid surgery, such as a thyroid lobectomy, as an outpatient procedure is generally safe. Studies indicate that patients experience high satisfaction and few complications when experienced doctors perform the surgery. One study found that issues related to hormone-producing glands are rare when patients go home the same day. Another study highlighted that same-day surgeries are not only safe but also help reduce medical costs. Overall, the research suggests that outpatient thyroid lobectomy is well-tolerated with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the possibility of performing thyroid lobectomies on an outpatient basis, which could revolutionize the recovery process for patients with thyroid disease. Unlike traditional methods that often require an overnight hospital stay, this approach could allow patients to go home the same day as surgery. This shift could lead to increased patient comfort, reduced healthcare costs, and enhanced use of hospital resources, all while maintaining safety and effectiveness in post-surgery recovery.

What evidence suggests that this trial's treatments could be effective for thyroid disease?

Research has shown that a thyroid lobectomy as an outpatient procedure, where patients go home the same day, is safe for certain individuals. This trial will evaluate patient-reported outcomes and safety in outpatient thyroid lobectomy. Studies have demonstrated that this method leads to high patient satisfaction and lowers healthcare costs. Specifically, one study found that performing thyroid surgeries in outpatient settings could reduce costs by up to 15.5%. Although unexpected problems can occur, the researchers are taking steps to reduce them. Overall, evidence supports that outpatient thyroid procedures can be a safe and cost-effective option. ^{2 3 6 7 8}

Who Is on the Research Team?

Paul Graham, M D

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I can communicate in English or another language.

Exclusion Criteria

Pregnant women will not be included in this study

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

I am at high risk of bleeding and cannot stop my blood-thinning medication for 5 days before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative

Participants complete a survey about the severity of symptoms at the pre-surgery visit

1 day

1 visit (in-person)

Surgery and Immediate Post-operative

Participants undergo thyroid lobectomy and are either discharged the same day or observed overnight

1-2 days

Follow-up

Participants are monitored for safety and effectiveness, including symptom severity scores at 24 hours and 2 weeks post-procedure

2 weeks

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Post-Surgery Surveys
• Pre-Surgery Survey

Trial Overview 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.

How Is the Trial Designed?

Group I: Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The Patient-Reported Outcome Measure for Parathyroid and Thyroid Disease (PROMPT) was developed and validated, showing high internal consistency and reliability, with a Cronbach's α of 0.84 for compressive symptoms and 0.95 for hyperparathyroidism symptoms based on 302 surveys over 10 months.

PROMPT effectively differentiates symptom severity, revealing that patients with goiters reported significantly higher compressive scores than those with nodules or hyperparathyroidism, and it demonstrated sensitivity to change, with hyperparathyroid scores improving post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a novel patient-reported outcome measure for parathyroid and thyroid disease (PROMPT). Burneikis, T., Colvin, J., Jin, J., et al.[2019]

A new surveillance model was developed to identify adverse events (AEs) in outpatient surgeries, using six electronic triggers and analyzing data from over 744,000 surgeries, which showed a 20% rate of AEs in reviewed cases.

The model demonstrated strong predictive ability, with an 85% positive predictive value for surgeries with a high probability of AEs, indicating it can effectively help in monitoring and improving patient safety in outpatient surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Adverse Event Surveillance Model for Outpatient Surgery in the Veterans Health Administration. Mull, HJ., Itani, KMF., Pizer, SD., et al.[2021]

Standardized data collection of postoperative adverse events in thoracic surgery can significantly enhance patient care by documenting and informing practices to reduce complications.

Engaging surgeons in audit and feedback based on this data can lead to consensus recommendations that improve patient outcomes following high-risk surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Postoperative Adverse Event Data Collection to Document, Inform, and Improve Patient Care. Shamji, FM., Gingrich, M., Anstee, C., et al.[2021]

In a review of outpatient surgeries from 2012 to 2015 involving 2,257 cases, adverse events (AEs) were found in 51% of high-likelihood and 12% of low-likelihood procedures, indicating a significant risk of complications even in outpatient settings.

Among the identified AEs, 10% required repeat surgeries, and 28% led to hospitalization, highlighting the need for quality improvement efforts to address common issues like wound problems and urinary retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nature and Severity of Adverse Events in Select Outpatient Surgical Procedures in the Veterans Health Administration. Mull, HJ., Itani, KMF., Charns, MP., et al.[2021]

Outpatient unilateral thyroid lobectomy is feasible and safe, with 62% of the 153 procedures performed planned for outpatient care, and no patients were readmitted after discharge.

The study highlights the importance of managing postoperative nausea and providing preoperative education to reduce patient anxiety, which can improve the overall acceptability of outpatient surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to perform a thyroidectomy in an outpatient setting. Champault, A., Vons, C., Zilberman, S., et al.[2021]

Patients are significantly less likely to attend preoperative assessment clinics as the distance from their home increases, with a notable drop in attendance for those living more than 250 km away (adjusted odds ratio of 0.26).

This geographical barrier to accessing preoperative care highlights the need for strategies to improve equitable access to healthcare services, especially for patients in rural and remote areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Location of residence associated with the likelihood of patient visit to the preoperative assessment clinic. Seidel, JE., Beck, CA., Pocobelli, G., et al.[2018]

In a study of 204 patients who underwent completion thyroidectomy after previous thyroid lobectomy, only 4.4% experienced postoperative complications, indicating that the procedure is generally safe.

The study found no significant difference in complication rates between patients observed for less than or more than 4 hours post-surgery, suggesting that selected patients can be safely discharged after a short observation period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of patients with completion thyroidectomy and assessment of their suitability for outpatient surgery. Wu, G., Pai, SI., Agrawal, N., et al.[2021]

A 12.5-year study involving 869 cases demonstrated that outpatient thyroidectomy (OPT) is a safe and effective alternative to standard thyroid surgery, allowing patients to avoid hospitalization.

The study supports the feasibility of OPT for selected patients with thyroid disease, highlighting its practicality and efficacy over traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient thyroidectomy. Samson, PS., Reyes, FR., Saludares, WN., et al.[2019]

The Surgical Risk Preoperative Assessment System (SURPAS) received positive feedback from both patients and healthcare providers, highlighting its potential to improve risk assessment processes and enhance patient involvement in decision-making.

Participants noted that while SURPAS is beneficial, it should complement clinical judgment rather than replace it, and there are mixed feelings among patients regarding the impact of risk information on their decision to undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of attitudes towards future implementation of the "Surgical Risk Preoperative Assessment System" (SURPAS) tool: a pilot survey among patients, surgeons, and hospital administrators. Lambert-Kerzner, A., Ford, KL., Hammermeister, KE., et al.[2022]

In a study of 106,915 patients, those who underwent total thyroidectomy were significantly less likely to require reoperation compared to those who had a lobectomy, with a 51% lower odds of returning to the operating room.

Key risk factors for reoperation after thyroid surgery included a history of hypertension, malignant pathology, and smoking, while diabetes and body mass index did not affect reoperation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Assessment in Thyroid Lobectomy and Total Thyroidectomy using Over 100 Thousand Cases. Brauer, PR., Burkey, BB., Reddy, CA., et al.[2022]

A study involving 275 patients found that while overall satisfaction with preoperative assessments for day surgery was high, General Surgery patients felt better prepared for hospital admission compared to Urology patients, indicating a significant difference in perceived preparedness (p = 0.046).

Key themes emerged from patient feedback highlighting the importance of effective communication, supportive attitudes, and addressing anxiety, suggesting that improvements in these areas could enhance the preoperative assessment experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived levels of satisfaction with the preoperative assessment service experienced by patients undergoing general anaesthesia in a day surgery setting. Fraczyk, L., Godfrey, H.[2015]

A systematic review of 41 articles identified 541 different data items collected during preoperative assessments, highlighting a significant diversity in the information gathered by anesthesiologists, nurses, and other professionals.

Only six data items, including age and diabetes, were consistently reported in over 50% of the studies, suggesting the need for a standardized core data set to improve data exchangeability in preoperative assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data collection variation in preoperative assessment: a literature review. Ahmadian, L., Cornet, R., Van Klei, WA., et al.[2018]

Outpatient thyroid surgery is safe and effective, with a low readmission rate of only 0.9% among 1,026 outpatient procedures performed, indicating that many patients can successfully recover at home.

The study showed that as the protocol for outpatient thyroidectomy was refined over time, the rate of temporary hypocalcemia complications decreased, demonstrating improved patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient thyroid surgery: Safety of an optimized protocol in more than 1,000 patients. Segel, JM., Duke, WS., White, JR., et al.[2019]

Outpatient subtotal thyroidectomy is a safe and effective procedure, as demonstrated by a study of 247 thyroid surgeries where 94 were performed on an outpatient basis without any complications.

This approach not only maintains patient safety but also offers potential financial benefits to the Canadian healthcare system, challenging the traditional view that thyroid surgery requires hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient thyroid surgery in a Toronto community hospital. Sklar, M., Ali, MJ., Solomon, P.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7989291/

Safety and cost-effectiveness of outpatient thyroidectomy We project that shifting thyroidectomy surgeries from inpatient to outpatient procedures will result in a 15.5% cost reduction.

2. trialx.com trialx.com/clinical-trials/listings/323882/a-randomized-control-trial-for-patient-reported-outcomes-and-safety-in-outpatient-thyroid-lobectomy/

A Randomized Control Trial for Patient Reported Outcomes ... Clinical trial for Thyroid Lobectomy , A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy.

3. withpower.com withpower.com/trial/phase-2-thyroid-diseases-3-2024-909aa

Outpatient Thyroid Lobectomy for Thyroid Disease Research on outpatient surgery, including thyroid lobectomy, shows that adverse events (unexpected problems after surgery) can occur, but efforts are being made ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961024001351

Clinical outcomes of outpatient thyroidectomy: A systematic ... Our analysis demonstrated that outpatient thyroidectomy is a safe procedure in the management of thyroid disease for selected patients.

5. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2021.717427/full

Feasibility and Safety of Outpatient Thyroidectomy Outpatient thyroidectomy is safe, associated with high patient satisfaction and decreased health costs when rigorous institutional protocols are established ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34363111/

Patient-reported outcomes following total thyroidectomy ... Current study aimed to assess patient-reported outcomes in thyroid cancer survivors comparing total thyroidectomy (TT) and lobectomy (LT)

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5566659/

Safety of same-day thyroidectomy: meta-analysis and ... The potential advantages of outpatient thyroid surgery entails three distinct categories: patient satisfaction, patient safety, and conservation of resources.

8. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/2473974X21995104

Ambulatory Surgery vs Overnight Observation for Total ... Outpatient total thyroidectomy can lead to cost reduction in highly selected patients who have few comorbidities while remaining safe for the patient.