Thyroid NoduleNCT04248114
Skin-crease Thyroidectomy
An observational study of Thyroid Nodule, run by Western Galilee Hospital-Nahariya.
Trial summary
We performed a retrospective observational-analytic study. Anatomical measurements were performed on 118 participants during an ultrasound exam, and demographic data was collected from their medical files. The data was stratified according to age, sex, patient's body mass index (BMI), and height. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Ultrasound of the Neck
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The data was collected during ultrasound exams of subjects who underwent assessment of the thyroid gland.
Who may be able to join
- Subjects who underwent assessment of the thyroid gland
Who cannot join
- Patients who had any neck surgical procedure prior to the test, patients with abnormalities in the anterior neck, and patients without clear second crease were excluded.
About this study
Official title: The Natural Neck Crease as an Anatomic Landmark for Thyroid Surgery Incision
We performed a retrospective observational-analytic study. Anatomical measurements were performed on 118 participants during an ultrasound exam, and demographic data was collected from their medical files. The data was stratified according to age, sex, patient's body mass index (BMI), and height.
Read the detailed description
Approval - Ethical Considerations The study was approved by the Institutional Review Board (NHR-014417). Study Design In this retrospective observational-analytic study we analyzed the anatomical relation between the cricoid cartilage, thyroid gland isthmus, and the superficial second neck crease. We reviewed patient data from between November 2016 and August 2018. The data was collected during ultrasound exams of 118 subjects who underwent assessment of the thyroid gland. Patients who had any neck surgical procedure prior to the test, patients with abnormalities in the anterior neck, and patients without clear second crease were excluded.
During the examination, patients were lying supine with their head in mild extension, in the same manner that is practiced during a thyroidectomy. The assessment and collection of data was performed by the senior author (OR) who routinely performs both this preoperative examination and thyroid surgeries in the medical center. The precise location of the cricoid cartilage and the thyroid isthmus was determined using ultrasound. The main parameters were the distances between the thyroid isthmus superior border and the second neck crease, and the distance between the cricoid cartilage superior border and the second neck crease. These were measured with a ruler with ultrasound imaging guidance (Figure 1).
Several neck creases can be observed in normal adults. The first upper crease runs horizontally roughly along the thyroid notch and hyoid bone. A second lower neck crease runs parallel to it approximately at the height of the cricoid and this is the crease the measurements in our study relate to. Occasionally there is a third prominent skin crease around 2-3 finger breadths above the clavicle. Other less prominent horizontal neck creases can be present.
Demographic variables, such as age, sex, BMI, and height, were collected from medical records and used for result stratification either as continuous variables or divided into sub-groups according to accepted divisions.
Sample size calculation The hypothesis was that the second neck crease is superficial to the thyroid gland isthmus superior border (0 cm horizontal distance). A vertical distance of 0.5 cm and more was considered significant difference in the location.
Statistical analysis Distance between the thyroid isthmus or the cricoid cartilage and the second neck crease were described by means, standard deviation, and range. Age, sex, BMI, and height were analyzed as quantitative variables with the measures mentioned above. The continuous variants were also grouped for a clearer presentation of the results. The BMI variant was categorized into accepted ranges: underweight (below 18.5 kg/m2), normal weight (18.5 to 25 kg/m2), overweight (25 to 30 kg/m2), and obese (over 30 kg/m2). BMI sub-groups and sex variables were described by frequencies and percentages.
The distances were compared among sub-groups using ANOVA, Kruskal-Wallis test, Independent sample t-test, and Wilcoxon rank sum test. The choice between those tests was according to the number of sub-groups, the group's sample size, and the distribution of the data in each sub-group.
A correlation between age, BMI, height, and the distance was tested by Pearson's correlation coefficient test or Spearman's correlation coefficient test. The choice between those tests was according to the sample size and the score's distribution. If the variable was defined as ordinal sub-groups, Spearman's correlation coefficient test was used.
- Conditions
- Thyroid Nodule
- Being tested
- Ultrasound of the Neck
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the NeckDiagnostic test
Anatomical measurements were performed on participants during an ultrasound exam
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical relations between the second neck skin crease and the thyroid gland isthmus and cricoid cartilage
Several neck creases can be observed in normal adults. The first upper crease runs horizontally roughly along the thyroid notch and hyoid bone. A second lower neck crease runs parallel to it approximately at the height of the cricoid; the measurements, in centimeters, in our study relate to this crease.
Measured: June 1st 2016 until August 31 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Nov 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ronen Ohad, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248114
- Sponsor's protocol ID
- NHR-014417
- Status last verified
- Oct 2021
- First submitted
- 28 Jan 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fancy T, Gallagher D 3rd, Hornig JD. Surgical anatomy of the thyroid and parathyroid glands. Otolaryngol Clin North Am. 2010 Apr;43(2):221-7, vii. doi: 10.1016/j.otc.2010.01.001.
PubMed 20510710Brunaud L, Zarnegar R, Wada N, Ituarte P, Clark OH, Duh QY. Incision length for standard thyroidectomy and parathyroidectomy: when is it minimally invasive? Arch Surg. 2003 Oct;138(10):1140-3. doi: 10.1001/archsurg.138.10.1140.
PubMed 14557134Choi Y, Lee JH, Kim YH, Lee YS, Chang HS, Park CS, Roh MR. Impact of postthyroidectomy scar on the quality of life of thyroid cancer patients. Ann Dermatol. 2014 Dec;26(6):693-9. doi: 10.5021/ad.2014.26.6.693. Epub 2014 Nov 26.
PubMed 25473220
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural Neck Crease as an Anatomic Landmark for Thyroid Surgery Incision
- ClinicalTrials.gov ID
- NCT04248114
- Acronym / sponsor ID
- NHR-014417
- Conditions
- Thyroid Nodule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We performed a retrospective observational-analytic study. Anatomical measurements were performed on 118 participants during an ultrasound exam, and demographic data was collected from their medical files. The data was stratified according to age, sex, patient's body mass index (BMI), and height.
Detailed description
Approval - Ethical Considerations The study was approved by the Institutional Review Board (NHR-014417). Study Design In this retrospective observational-analytic study we analyzed the anatomical relation between the cricoid cartilage, thyroid gland isthmus, and the superficial second neck crease. We reviewed patient data from between November 2016 and August 2018. The data was collected during ultrasound exams of 118 subjects who underwent assessment of the thyroid gland. Patients who had any neck surgical procedure prior to the test, patients with abnormalities in the anterior neck, and patients without clear second crease were excluded.
During the examination, patients were lying supine with their head in mild extension, in the same manner that is practiced during a thyroidectomy. The assessment and collection of data was performed by the senior author (OR) who routinely performs both this preoperative examination and thyroid surgeries in the medical center. The precise location of the cricoid cartilage and the thyroid isthmus was determined using ultrasound. The main parameters were the distances between the thyroid isthmus superior border and the second neck crease, and the distance between the cricoid cartilage superior border and the second neck crease. These were measured with a ruler with ultrasound imaging guidance (Figure 1).
Several neck creases can be observed in normal adults. The first upper crease runs horizontally roughly along the thyroid notch and hyoid bone. A second lower neck crease runs parallel to it approximately at the height of the cricoid and this is the crease the measurements in our study relate to. Occasionally there is a third prominent skin crease around 2-3 finger breadths above the clavicle. Other less prominent horizontal neck creases can be present.
Demographic variables, such as age, sex, BMI, and height, were collected from medical records and used for result stratification either as continuous variables or divided into sub-groups according to accepted divisions.
Sample size calculation The hypothesis was that the second neck crease is superficial to the thyroid gland isthmus superior border (0 cm horizontal distance). A vertical distance of 0.5 cm and more was considered significant difference in the location.
Statistical analysis Distance between the thyroid isthmus or the cricoid cartilage and the second neck crease were described by means, standard deviation, and range. Age, sex, BMI, and height were analyzed as quantitative variables with the measures mentioned above. The continuous variants were also grouped for a clearer presentation of the results. The BMI variant was categorized into accepted ranges: underweight (below 18.5 kg/m2), normal weight (18.5 to 25 kg/m2), overweight (25 to 30 kg/m2), and obese (over 30 kg/m2). BMI sub-groups and sex variables were described by frequencies and percentages.
The distances were compared among sub-groups using ANOVA, Kruskal-Wallis test, Independent sample t-test, and Wilcoxon rank sum test. The choice between those tests was according to the number of sub-groups, the group's sample size, and the distribution of the data in each sub-group.
A correlation between age, BMI, height, and the distance was tested by Pearson's correlation coefficient test or Spearman's correlation coefficient test. The choice between those tests was according to the sample size and the score's distribution. If the variable was defined as ordinal sub-groups, Spearman's correlation coefficient test was used.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data was collected during ultrasound exams of subjects who underwent assessment of the thyroid gland.
Key inclusion criteria (1 listed)
- Subjects who underwent assessment of the thyroid gland
Key exclusion criteria (1 listed)
- Patients who had any neck surgical procedure prior to the test, patients with abnormalities in the anterior neck, and patients without clear second crease were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound of the NeckAnatomical measurements were performed on participants during an ultrasound exam | Diagnostic test | – |
Primary outcome
anatomical relations between the second neck skin crease and the thyroid gland isthmus and cricoid cartilage
Time frame: June 1st 2016 until August 31 2018
Several neck creases can be observed in normal adults. The first upper crease runs horizontally roughly along the thyroid notch and hyoid bone. A second lower neck crease runs parallel to it approximately at the height of the cricoid; the measurements, in centimeters, in our study relate to this crease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Results publication: PubMed 20510710Fancy T, Gallagher D 3rd, Hornig JD. Surgical anatomy of the thyroid and parathyroid glands. Otolaryngol Clin North Am. 2010 Apr;43(2):221-7, vii. doi: 10.1016/j.otc.2010.01.001.
- Results publication: PubMed 14557134Brunaud L, Zarnegar R, Wada N, Ituarte P, Clark OH, Duh QY. Incision length for standard thyroidectomy and parathyroidectomy: when is it minimally invasive? Arch Surg. 2003 Oct;138(10):1140-3. doi: 10.1001/archsurg.138.10.1140.
- Results publication: PubMed 25473220Choi Y, Lee JH, Kim YH, Lee YS, Chang HS, Park CS, Roh MR. Impact of postthyroidectomy scar on the quality of life of thyroid cancer patients. Ann Dermatol. 2014 Dec;26(6):693-9. doi: 10.5021/ad.2014.26.6.693. Epub 2014 Nov 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by Western Galilee Hospital-Nahariya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anatomical relations between the second neck skin crease and the thyroid gland isthmus and cricoid cartilage (time frame: June 1st 2016 until August 31 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04248114, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.