NCT05699304

Brief 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. The current study was conducted to report the incidence and predictive factors for perioperative complications, aiming to point out preventive measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

January 16, 2023

Last Update Submit

October 21, 2023

Conditions

Keywords

ThyroidectomyHypocalcemiaStridorBleedingRecurrent Laryngeal Nerve

Outcome Measures

Primary Outcomes (3)

  • Recurrent Laryngeal nerve injury

    Recurrent Laryngeal nerve injury

    1 week

  • Bleeding

    intraoperative or post operative bleeding.

    2 days

  • Hypocalcemia

    Clinically significant low serum calcium level/

    6 months

Interventions

ThyroidectomyPROCEDURE

Thyroidectomy

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients had thyroid diseases and had thyroidectomy in our hospital in last 10 years.

You may qualify if:

  • All patients had thyroid disease and performed thyroidectomy in the last 10 years in our hospital.

You may not qualify if:

  • Uncompleted files.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena Faculty of Medicine, South Valley University Hospitals

Qina, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 21966659BACKGROUND
  • Ernandes-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.

    PMID: 22714849BACKGROUND
  • Zambudio 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.

    PMID: 15213613BACKGROUND
  • Khanzada 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.

    PMID: 21409907BACKGROUND
  • Potenza 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.

    PMID: 29142848BACKGROUND

MeSH Terms

Conditions

Thyroid DiseasesHypocalcemiaRespiratory SoundsHemorrhage

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Endocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte ImbalanceSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Abdallah M Taha, MD

    South Valley University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 26, 2023

Study Start

January 30, 2023

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations