ObesityNCT04273711
Can Thyroidectomy be Considered Safe in Obese Patients?
An observational study of Obesity and Thyroid, run by University of Cagliari at 1 site in Italy.
Trial summary
Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Thyroid, Surgery--Complications
- How many people
- 813 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2019to 1 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients submitted to thyroidectomy
Who may be able to join
- Patients submitted to thyroidectomy in our Unit
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Thyroidectomy be Considered Safe in Obese Patients? Retrospective Cohort Study
Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. This study showed that obesity, in the field of thyroid surgery, is not associated with any increase of postoperative complications. Thus, it is possible to conclude that thyroidectomy can be performed safely in obese patients.
Read the detailed description
Background: Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. The aim of the present study was to evaluate whether thyroidectomy can be considered safe in obese patients.
Methods: Patients undergoing thyroidectomy in our Unit between January 2014 and December 2018 were retrospectively analysed. Patients were divided into 2 groups: those with BMI < 30 kg/m2 were included in Group A, while those with BMI ≥ 30 kg/m2 in Group B.
- Conditions
- Obesity, Thyroid, Surgery--Complications
- Medical subject headings
- Obesity, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Not described | |
| Non-obese patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Occurrence of postoperative complications
Measured: 1 year
Secondary outcomes (1)
Operative time
Evaluation of operatives times
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Dec 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 813 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Medas, University of Cagliari
- Investigators
- Pietro Giorgio Calò, Study director, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273711
- Sponsor's protocol ID
- NP20193369
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Thyroidectomy be Considered Safe in Obese Patients? Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04273711
- Acronym / sponsor ID
- NP20193369
- Conditions
- Obesity, Thyroid, Surgery--Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 813 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 18 Feb 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.
Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. This study showed that obesity, in the field of thyroid surgery, is not associated with any increase of postoperative complications. Thus, it is possible to conclude that thyroidectomy can be performed safely in obese patients.
Detailed description
Background: Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. The aim of the present study was to evaluate whether thyroidectomy can be considered safe in obese patients.
Methods: Patients undergoing thyroidectomy in our Unit between January 2014 and December 2018 were retrospectively analysed. Patients were divided into 2 groups: those with BMI < 30 kg/m2 were included in Group A, while those with BMI ≥ 30 kg/m2 in Group B.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | – |
| Non-obese patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients submitted to thyroidectomy
Key inclusion criteria (1 listed)
- Patients submitted to thyroidectomy in our Unit
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative complications
Time frame: 1 year
Occurrence of postoperative complications
1 secondary outcome
Operative time
Time frame: 1 day
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 18 Feb 2020.
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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.
Pietro Giorgio Calò study director
University of Cagliari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Thyroid, run by University of Cagliari at 1 site in Italy.
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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Postoperative complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2020.