ThyroidNCT05699304
Complications After Thyroid Surgeries: 10 Years' Experience
An observational study of Thyroid, run by South Valley University at 1 site in Egypt.
Trial summary
Thyroidectomy is one of the commonest elective surgeries in surgical practice nowadays. It is associated with wide range of complications, from unnoticed events up to lifelong problems and even life-threatening complications. The most troublesome are bleeding, nerve injury and hypocalcemia. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Thyroid
- What is being tested?
- Thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 241 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2023to 1 Sep 2023
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients had thyroid diseases and had thyroidectomy in our hospital in last 10 years.
Who may be able to join
- All patients had thyroid disease and performed thyroidectomy in the last 10 years in our hospital.
Who cannot join
- Uncompleted files.
Trial locations and contacts
1 site in 1 country.
About this study
Thyroidectomy is one of the commonest elective surgeries in surgical practice nowadays. It is associated with wide range of complications, from unnoticed events up to lifelong problems and even life-threatening complications. The most troublesome are bleeding, nerve injury and hypocalcemia. The current study was conducted to report the incidence and predictive factors for perioperative complications, aiming to point out preventive measures.
Read the detailed description
All files of all patients that had thyroidectomy in the hospital in the last 10 yeas will be reviewed. All demographic and peri-operative data will be collected, tabulated and analyzed.
Incidence and pre-operative predictive factors of every single complication will pointed out and discussed.
- Conditions
- Thyroid
- Being tested
- Thyroidectomy
- Keywords
- Thyroidectomy, Hypocalcemia, Stridor, Bleeding, Recurrent Laryngeal Nerve
- Medical subject headings
- Thyroid Diseases, Hypocalcemia, Respiratory Sounds, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroidectomyProcedure or surgery
Thyroidectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Laryngeal nerve injury
Recurrent Laryngeal nerve injury
Measured: 1 week
Bleeding
intraoperative or post operative bleeding.
Measured: 2 days
Hypocalcemia
Clinically significant low serum calcium level/
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start30 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ThyroidStudies 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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Mohamed Taha Aly, South Valley University
- Investigators
- Abdallah M Taha, MD, Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699304
- Sponsor's protocol ID
- SVU-MED-SUR011-4-22-12-515
- Status last verified
- Oct 2023
- First submitted
- 16 Jan 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ogbera AO, Kuku SF. Epidemiology of thyroid diseases in Africa. Indian J Endocrinol Metab. 2011 Jul;15(Suppl 2):S82-8. doi: 10.4103/2230-8210.83331.
PubMed 21966659Ernandes-Neto M, Tagliarini JV, Lopez BE, Padovani CR, Marques Mde A, Castilho EC, Mazeto GM. Factors influencing thyroidectomy complications. Braz J Otorhinolaryngol. 2012 Jun;78(3):63-9. doi: 10.1590/S1808-86942012000300012.
PubMed 22714849Zambudio AR, Rodriguez J, Riquelme J, Soria T, Canteras M, Parrilla P. Prospective study of postoperative complications after total thyroidectomy for multinodular goiters by surgeons with experience in endocrine surgery. Ann Surg. 2004 Jul;240(1):18-25. doi: 10.1097/01.sla.0000129357.58265.3c.
PubMed 15213613Khanzada TW, Samad A, Memon W, Kumar B. Post thyroidectomy complications: the Hyderabad experience. J Ayub Med Coll Abbottabad. 2010 Jan-Mar;22(1):65-8.
PubMed 21409907Potenza AS, Araujo Filho VJF, Cernea CR. Injury of the external branch of the superior laryngeal nerve in thyroid surgery. Gland Surg. 2017 Oct;6(5):552-562. doi: 10.21037/gs.2017.06.15.
PubMed 29142848
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications After Thyroid Surgeries: 10 Years' Experience
- ClinicalTrials.gov ID
- NCT05699304
- Acronym / sponsor ID
- SVU-MED-SUR011-4-22-12-515
- Conditions
- Thyroid
- Keywords
- Thyroidectomy, Hypocalcemia, Stridor, Bleeding, Recurrent Laryngeal Nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 26 Jan 2023 (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.
Thyroidectomy is one of the commonest elective surgeries in surgical practice nowadays. It is associated with wide range of complications, from unnoticed events up to lifelong problems and even life-threatening complications. The most troublesome are bleeding, nerve injury and hypocalcemia. The current study was conducted to report the incidence and predictive factors for perioperative complications, aiming to point out preventive measures.
Detailed description
All files of all patients that had thyroidectomy in the hospital in the last 10 yeas will be reviewed. All demographic and peri-operative data will be collected, tabulated and analyzed.
Incidence and pre-operative predictive factors of every single complication will pointed out and discussed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients had thyroid diseases and had thyroidectomy in our hospital in last 10 years.
Key inclusion criteria (1 listed)
- All patients had thyroid disease and performed thyroidectomy in the last 10 years in our hospital.
Key exclusion criteria (1 listed)
- Uncompleted files.
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 |
|---|---|---|
| ThyroidectomyThyroidectomy | Procedure or surgery | – |
Primary outcome
Recurrent Laryngeal nerve injury
Time frame: 1 week
Recurrent Laryngeal nerve injury
Bleeding
Time frame: 2 days
intraoperative or post operative bleeding.
Hypocalcemia
Time frame: 6 months
Clinically significant low serum calcium level/
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 24 Oct 2023.
- Background: PubMed 21966659Ogbera AO, Kuku SF. Epidemiology of thyroid diseases in Africa. Indian J Endocrinol Metab. 2011 Jul;15(Suppl 2):S82-8. doi: 10.4103/2230-8210.83331.
- Background: PubMed 22714849Ernandes-Neto M, Tagliarini JV, Lopez BE, Padovani CR, Marques Mde A, Castilho EC, Mazeto GM. Factors influencing thyroidectomy complications. Braz J Otorhinolaryngol. 2012 Jun;78(3):63-9. doi: 10.1590/S1808-86942012000300012.
- Background: PubMed 15213613Zambudio AR, Rodriguez J, Riquelme J, Soria T, Canteras M, Parrilla P. Prospective study of postoperative complications after total thyroidectomy for multinodular goiters by surgeons with experience in endocrine surgery. Ann Surg. 2004 Jul;240(1):18-25. doi: 10.1097/01.sla.0000129357.58265.3c.
- Background: PubMed 21409907Khanzada TW, Samad A, Memon W, Kumar B. Post thyroidectomy complications: the Hyderabad experience. J Ayub Med Coll Abbottabad. 2010 Jan-Mar;22(1):65-8.
- Background: PubMed 29142848Potenza AS, Araujo Filho VJF, Cernea CR. Injury of the external branch of the superior laryngeal nerve in thyroid surgery. Gland Surg. 2017 Oct;6(5):552-562. doi: 10.21037/gs.2017.06.15.
- 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.
Abdallah M Taha, MD principal investigator
South Valley University
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 Thyroid, run by South Valley University at 1 site in Egypt.
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 24 Oct 2023. 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 Egypt. 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?
Recurrent Laryngeal nerve injury (time frame: 1 week). The study lists 3 primary outcomes in all. 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 NCT05699304, which also lists 5 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 24 Oct 2023.