Protocol summary

Study aim
Determining and comparing the percentage of patients who need tracheostomy; Incidence of dysphagia, hoarseness, aphonia, average score of hypocalcemia, hematoma after total thyroidectomy surgery with and without exploration of the recurrent laryngeal nerve in each of the study groups.
Design
Clinical trial with control group, with parallel group, without blinding, randomized, without phase, on 114 patients. The rand function of Excel software is used for randomization.
Settings and conduct
Total thyroidectomy candidate patients referred to Shahid Jalil Hospital in Yasouj city will be included in the study if they meet the inclusion criteria. The study will be a post-test with a control group. Recurrent nerve exploration will be done for the intervention group. Compared to the previous group, the surgery of the control group will be performed without exploration by the surgeon.
Participants/Inclusion and exclusion criteria
Declaring willingness to participate in the study after filling out the informed consent form by the patient, the patient is a candidate for total thyroidectomy, age between 18-70, no previous neck surgery, no history of neck radiation, no vocal cord disorders, no History of parathyroid hormone disorder, no kidney disorders, preoperative blood calcium level within normal range, patient's unwillingness to continue cooperation, patient's death.
Intervention groups
Candidate patients for total thyroidectomy, provided they meet the entry criteria
Main outcome variables
The percentage of patients requiring tracheostomy Incidence of dysphagia, voice harshness, aphonia, hypocalcemia average score, hematoma after total thyroidectomy surgery with and without recurrent laryngeal nerve exploration is different in each of the study groups;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240601061973N1
Registration date: 2024-10-09, 1403/07/18
Registration timing: registered_while_recruiting

Last update: 2024-10-09, 1403/07/18
Update count: 0
Registration date
2024-10-09, 1403/07/18
Registrant information
Name
Saadat Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7001
Email address
dr.shimafard@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of hypocalcemia and complications caused by recurrent laryngeal nerve injury during total thyroidectomy in complete exposure versus non exposure of the recurrent laryngeal nerve
Public title
A comparative study of hypocalcemia and complications caused by recurrent laryngeal nerve injury during total thyroidectomy in complete exposure versus non exposure of the recurrent laryngeal nerve
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of radiation to the neck، Absence of any disorder in the vocal cords، Having no history of parathyroid hormone disorders ، Having no history of renal disease , Preoperative blood calcium level within normal range , Declaring willingness to participate in the study after filling the informed consent form by the patient , The patient is a candidate for total thyroidectomy , Age between 18-70 , No history of previous neck surgery
Exclusion criteria:
The patient's unwillingness to continue cooperation Death of the patient
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is simple randomization. If the patients meet the inclusion criteria, they will be placed in the intervention and control groups one at a time, and this will continue until the desired sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasouj University of Medical Sciences
Street address
Jalil Hospital; Emam reza St ; shahid Gharani Blvd; Yasouj Town
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Approval date
2024-05-25, 1403/03/05
Ethics committee reference number
IR.YUMS.REC.1403.016

Health conditions studied

1

Description of health condition studied
Postprocedural hypoparathyroidism
ICD-10 code
E89.2
ICD-10 code description
Postprocedural hypoparathyroidism

Primary outcomes

1

Description
hypocalcemia
Timepoint
Before the operation, 7 and 14 days after the operation
Method of measurement
Blood calcium with a laboratory kit,

Secondary outcomes

1

Description
Need for tracheostomy, aphonia, voice harshness, dysphagia, hematoma
Timepoint
Immediately after the operation, 7 and 14 days later
Method of measurement
Based on the history of the patient and looking and examination by the surgeon

Intervention groups

1

Description
Intervention group: exploring the recurrent nerve during thyroidectomy
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Jalil Hospital of Yasouj town
Full name of responsible person
Saadat Mehrabi
Street address
Shahid Jalil Hospital; Emamreza St ; Shahid Gharani Blvd; Yasouj Town
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7002
Email
dr.shimafard@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Saadat Mehrabi
Street address
Jalil Hospital; Emamreza St; Shahid Gharani Blvd
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Email
dr.s.meh544@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Saadat Mehrabi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Jalil Hospital; Emamreza St; Shahid Gharani Blvd
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
0098 74 3333002
Email
dr.s.meh544@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Saadat Mehrabi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Jalil hosp; Emamreza St; Shahid Gharani Blvd
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 2003
Email
dr.s.meh544@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Shima Farde Manouchehri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Jalil hospital;EmamrezaSt; Shahid Gharani Blvd
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7003
Email
dr.shimafard@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Laboratory results and recorded evidence can be published if the patient's name is removed
When the data will become available and for how long
April 2024 to April 2025
To whom data/document is available
Doctors and medical students
Under which criteria data/document could be used
There is no limit
From where data/document is obtainable
Jalil hospital in Yasouj Town
What processes are involved for a request to access data/document
Send request to email dr.shimafard@gmail.com
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