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Comparing post-operative complication of Ligasure Small Jaw Instrument with clamp and tie method in thyroidectomy patients : A Clinical Trial

Protocol summary

Summary
In current study, we aim to discuss effect of Ligasure Small Jaw Instrument on hypocalcemia prevalence decrease in thyroidectomy patients. One hundred and fifty patients with thyroidectomy indication, who will be admitted in surgery wards of Tabriz Taleghani and Emam Reza hospitals from March 2014 till March 2015, enroll our study. All patients take part in case or control group by their own willing, as they choose surgery method on their own, and some will receive Ligasure Small Jaw and others Clamp and tie method.( P less than 0.05 is statistically significant) Sampling is non-randomized and census and patients candidate for thyroidectomy such as thyroidectomy cancers will enroll our study. All patients will be visited one day, one week and 6 week after operation, in order to evaluating their complications after surgery such as: vocal cord paresis, hematoma, hemorrhage,wound infection, and chronic pain. This examinations will be done by a surgeon, and data will be recorded carefully.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014030316077N2
Registration date: 2014-05-29, 1393/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-29, 1393/03/08
Registrant information
Name
Ali Ramouz
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3441 3895
Email address
ali.ramouz@gmail.com
Recruitment status
Recruitment complete
Funding source
Students Research Committee, Tabriz University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2015-04-04, 1394/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing post-operative complication of Ligasure Small Jaw Instrument with clamp and tie method in thyroidectomy patients : A Clinical Trial
Public title
Ligasure Small Jaw Instrument effect on decreasing post-operative complications in thyroidectomy patients in comparison to Clamp and Tie method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Multinoduler Goiter; Thyroid cancers; Retrosternal Goiter Exclusion criteria: Vocal cord paralysis; Secondary thyroid surgery; History of head and neck surgeries; Concurrent parathyroid diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Because, patients choose their surgery method by their own willing and due to their financial statement, so the study is non-randomized and non-blinded.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Research and Technology Department, Tabriz University of Medical Sciences
Street address
Research and technology department- Daneshgah Street- Tabriz
City
Tabriz
Postal code
Approval date
2014-02-26, 1392/12/07
Ethics committee reference number
92207

Health conditions studied

1

Description of health condition studied
Thyroid diseases
ICD-10 code
E07
ICD-10 code description
Other disorders of thyroid

Primary outcomes

1

Description
Investigating recurrent laryngeal nerve paralysis incidence in patients undergo surgery with 2 methods
Timepoint
Before Surgery- During post-operative extubation- 1 day after surgery- 6 week after surgery
Method of measurement
Checking vocal cords, Patient voice tone

Secondary outcomes

1

Description
Evaluating neck hematoma prevalence in patients undergo surgery by both surgery methods
Timepoint
1 days after surgery- 1 week after surgery- 6 week after surgery
Method of measurement
Surgery area examination, Conterol neck CT scan

Intervention groups

1

Description
Thyroidectomy by Ligasure small jaw instrument: Ligasure Small Jaw Instrument helps to coagulate and cut the thyroid nutrient vessels without any knot and suture, and facilitates thyroid resection procedure.
Category
Treatment - Surgery

2

Description
Thyroidectomy by Clamp and Tie method: This method is also known as Conventional thyroidectomy, which perform by several knots on nutrient vessels of thyroid, for completing thyroid resection.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Emam Reza Hospital and Tabriz Shahid Taleghani Hospital
Full name of responsible person
Street address
Emam Reza hospital, Daneshgah Street, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Student research committee, Tabriz University of Medical Sciences
Full name of responsible person
Hossein Mazouchian
Street address
Student Research Committee of Tabriz University of Medical Sciences, Pashmine Complex, Daneshgah Street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student research committee, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Ramouz
Position
Medical student
Other areas of specialty/work
Street address
Ramouz building, Rah ahan Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1441 3895
Fax
Email
ali.ramouz@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyed Ziaeddin Rasi Hashemi
Position
Thoracic Surgery Subspecialist
Other areas of specialty/work
Street address
Emam Reza Hospital, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1441 3895
Fax
Email
zia.hashemi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student Research Committee, Tabriz University of Medical Sciences
Full name of responsible person
Ali Ramouz
Position
Student
Other areas of specialty/work
Street address
Student Research Committee, Pashmine Complex, Daneshgah Street, Tabriz, Iran
City
Tabriz
Postal code
Phone
00
Fax
Email
ali.ramouz@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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