Outpatient Thyroid Lobectomy for Thyroid Disease

Overseen by Paul Graham, M D

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Aspirin, Antiplatelet, Anticoagulation

Disqualifiers: Bleeding risk, Poor health, Distance, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Outpatient Thyroid Lobectomy for Thyroid Disease?

Research shows that outpatient preoperative assessment clinics provide benefits to patients and the healthcare system, suggesting that outpatient thyroid lobectomy could be feasible and safe. Additionally, patient-reported outcome measures have been validated for thyroid disease, indicating that patients can effectively report their symptoms and response to surgery. ^{1 2 3 4 5}

Is outpatient thyroid lobectomy generally safe for humans?

Research on outpatient surgery, including thyroid lobectomy, shows that adverse events (unexpected problems after surgery) can occur, but efforts are being made to monitor and reduce these events to improve patient safety. ^{6 7 8 9 10}

How is outpatient thyroid lobectomy different from other treatments for thyroid disease?

Outpatient thyroid lobectomy is unique because it allows patients to have thyroid surgery without needing to stay overnight in the hospital, which is different from traditional inpatient care. This approach is shown to be safe and feasible, making it a convenient option for selected patients. ^{3 11 12 13 14}

Research Team

Paul Graham, M D

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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 18 years old or older.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Post-Surgery Surveys (Behavioral Intervention)
• Pre-Surgery Survey (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Findings from Research

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]

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]

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 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 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]

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]

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]

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 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]

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]

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]

References

1. England 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. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Validation of a novel patient-reported outcome measure for parathyroid and thyroid disease (PROMPT). [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

How to perform a thyroidectomy in an outpatient setting. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Location of residence associated with the likelihood of patient visit to the preoperative assessment clinic. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Risk Assessment in Thyroid Lobectomy and Total Thyroidectomy using Over 100 Thousand Cases. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Development of an Adverse Event Surveillance Model for Outpatient Surgery in the Veterans Health Administration. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Standardized Postoperative Adverse Event Data Collection to Document, Inform, and Improve Patient Care. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Data collection variation in preoperative assessment: a literature review. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

The Nature and Severity of Adverse Events in Select Outpatient Surgical Procedures in the Veterans Health Administration. [2021]

10. England 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Profile of patients with completion thyroidectomy and assessment of their suitability for outpatient surgery. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Outpatient thyroid surgery: Safety of an optimized protocol in more than 1,000 patients. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Outpatient thyroid surgery in a Toronto community hospital. [2013]

14. United States pubmed.ncbi.nlm.nih.gov

Outpatient thyroidectomy. [2019]