Benign Thyroid Nodule Removal and Patient Satisfaction

The thyroid plays an important role in producing hormones that the blood carries to every tissue in the body. The thyroid helps regulate metabolism, the process by which the body turns food into energy, and keeps the organs functioning properly by helping the body conserve heat. A thyroid nodule is a lump in or on the thyroid gland. Benign thyroid nodules are detected in about 6 percent of women and 1-2 percent of men; they occur 10 times as often in older individuals, but are usually not diagnosed.

Diagnosed benign thyroid nodules (BTNs) affect 18.6% of citizens worldwide. BTNs include: Multinodular goiter (also called a nontoxic goiter), benign follicular adenomas, and thyroid cysts (nodules filled with fluid). The word goiter means the thyroid gland has grown too large. This usually happens when the pituitary gland in the brain creates too much thyroid stimulating hormone. If the goiter is small, the problem may be treated with thyroid hormone pills. Since medication therapy is rarely effective, the common interventional methods for treating benign thyroid nodules include conventional thyroidectomy, endoscopic thyroidectomy, and thyroid thermal ablation.

The two treatment methods used most frequently for benign thyroid nodules include:

Thyroid ablation- Thyroid thermal ablation does not leave a surgical incision on the neck, takes less operative time, it destroys the nodules thermally. Allows patients early return to routine life

Conventional thyroidectomy- Thyroid lobes are removed by surgical intervention.

Both common methods come with disadvantages. For instance, researchers noted that most patients that undergo thyroid thermal ablation require a significant amount of time for the absorption of benign thyroid nodules. Several patients after total thyroidectomy require replacement, usually with Synthroid medication, and oral replacement has some side effects if inappropriately dosed.

 

Study Design

This study was an open-label, parallel-group, randomized controlled trial in two main hospitals in South China.  The objective of the study was to compare the complications and treatment effects of conventional thyroidectomy and thyroid thermal ablation to identify the best intervention for patients with a benign thyroid nodule. Co-primary outcomes aimed to compare the patient’s satisfaction and quality of life scores after treatment for BTN.

Participants were placed on waiting lists after randomization. Patients received treatment within 12–18 weeks after random assignment. Responsible surgeons have been certified to be competent for both procedures. The surgeons were also responsible for other aspects of care.

The research team collected peri-operative data from the time of randomization. During the follow-up, self-completed questionnaires were completed by participants at baseline (before surgery), the 6th post-operative week, 6th post-operative month, and 15th post-randomization month, and were monitored meticulously.

Researchers were collecting self-completed 2-week diaries from patients. Up to two reminders were sent to non-responders depending on the preferred communications of the patients.

Pathology results were obtained for all thyroid specimens and nodules biopsies. Researchers aim to ensure that participants could complete their questionnaires at the 12th postoperative month (approximately the 15th post-randomization month). Standard classifications were used to define serious adverse effects.

SPSS 22.0 (Cytel, Cambridge, Massachusetts, USA) was used for all analysis. The trial was registered within the Chinese Clinical Trial Registry with a registration number: ChiCTR1800015531.

All procedures performed in studies involving human participants were following the ethical standards of the institutional review boards of Zhuhai People’s Hospital and Affiliated Foshan Hospital of Southern Medical University and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The participants gave consent for their personal and clinical details along with any identifying images to be published in this study.

Subjects of the Study

The subjects of the study are the patients with the age range of 18–50 years old who had benign thyroid nodules and were eligible for both thyroidectomy and thyroid thermal ablation were randomly allocated (1:1) to either the conventional thyroidectomy group or the thyroid thermal ablation group.

A total of 450 patients were enrolled and randomized 225 patients in each group of treatments.

Patients’ satisfaction and condition-specific quality of life were measured with the Thyroid-Specific Quality-of-Life Questionnaire Scale (QoL) at the 15th post-randomization month and were set as the co-primary outcome.

Statistical Analysis

Between May 14, 2016, and October 10, 2018, all BTN study patients were enrolled and randomly assigned to the two treatments. 97% of patients who underwent thyroid thermal ablation were satisfied with the treatment compared to those in the conventional thyroidectomy group in which 86% of patients were satisfied.

Patients randomly assigned to the thyroid thermal ablation group reported higher total psychological well-being scores and total social well-being scores at the 6th postoperative week.

At the 15th post-randomization month, patients in the conventional thyroidectomy group had better scores for total physical well being while patients in the thyroid thermal ablation group had better scores for total social well-being.

One patient in the conventional thyroidectomy group had two adverse events such as infection and a drainage tube problem. Patients randomly assigned to the conventional thyroidectomy group had higher pain scores compared to thyroid thermal ablation. Other complications were rare but more instances of immediate short-term cough exist in conventional thyroidectomy.

More patients in the thyroid thermal ablation group have a Quality of Life score of 410 than patients in conventional thyroidectomy.

Limitations of the study

The researchers mainly focus on Thyroid ablation and Conventional thyroidectomy treatments thus, adverse events that were unrelated to this study were not recorded.

Researchers claimed that this study has some limitations, including possible selection bias, misclassification, and inaccurate responses to questionnaires.

Study Results

At the 15th month after randomization, more patients in the thyroid thermal ablation group were satisfied with the treatment effects compared to those in the conventional thyroidectomy group.

Conventional thyroidectomy was associated with increased operative time and hospital stay length. In total, 202 (98%) of 206 patients allocated to conventional thyroidectomy had a longer postoperative hospital stay. While only 33 (16%) of 207 patients allocated to thyroid thermal ablation had a postoperative hospital stay.

Researchers saw the results in thyroid thermal ablation led to a greater improvement in less intraoperative blood loss, less operative time, quicker post-operative recovery, and better cosmetic results, without incurring a higher risk of post-operative complications.

A clinical benefit of both surgery methods has been indicated by the study results. However, sense disruptions in the throat, dysphagia, compression on the trachea, and hoarseness were seen for conventional thyroidectomy procedures compared to thyroid thermal ablation. Measures of satisfaction and quality of life scores were more positive for thyroid thermal ablation.

Although a reduction in symptoms of neck mass was associated with both procedures, more marked improvement was achieved in patients in the conventional thyroidectomy group, possibly because the benign tumor nodules were removed. Therefore, conventional thyroidectomy appears to be a more effective overall treatment method for large benign thyroid nodules causing compression than thyroid thermal ablation.

According to the researchers, it has been shown in a previous participant data meta-analysis that thyroid thermal ablation takes some advantages over conventional thyroidectomy since conventional thyroidectomy was noted to be more invasive than thyroid thermal ablation.

The trials reported in individual participant data via meta-analysis and systematic reviews comparing conventional thyroidectomy to thyroid thermal ablation that both conventional thyroidectomy and thyroid thermal ablation improved symptoms of a neck mass. As found by a previous study, for patients undergoing thyroid thermal ablation, the volume reduction rate of BTN could reach 90% in 18 months.

The study showed a longer hospital stay in the conventional thyroidectomy group. The researchers observed that Chinese surgeons tend to observe patients after thyroidectomy for about 3–5 days in case of postoperative hemorrhage and other complications are visible in the patients.

Thyroid thermal ablation could be provided as a convenient outpatient procedure with a local anesthetic, quicker recovery, less invasion, and more cosmetic effects.

Conclusion

Researchers concluded that thyroid thermal ablation is superior to conventional thyroidectomy in terms of patients satisfaction, postoperative quality of life, and shorter hospital stay but takes longer to achieve Benign thyroid nodules volume reduction.

In conclusion, patients’ quality of life and satisfaction is higher for patients undergoing thyroid thermal ablation than patients undergoing conventional thyroidectomy. The reasons may be thyroid thermal ablation takes shorter operative times, recovery time, and hospital stay and brings better cosmetic outcomes than conventional thyroidectomy, without any additional risk of complications. In the 15th post-randomization month, patients in the thyroid thermal ablation group were more likely to recommend the therapy method to their relatives and friends

By this study, the researchers could conclude that thyroid thermal ablation brings higher patient quality of life and satisfaction scores. For eligible patients, thyroid thermal ablation might be an ideal choice.