Suspended

Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Thyroidectomy using harmonic focus (r)

+ Conventional thyroidectomy

DeviceProcedure
Who is being recruted

Endocrine System Diseases

+ Thyroid Diseases

+ Goiter

From 18 to 65 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorS.B. Konya Education and Research Hospital
Study ContactOsman DOĞRU, M.D.More contacts
Last updated: March 24, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

We see new advances in the practice of surgery nearly everyday. New techniques and devices became available and even newer ones are under developement. Ultrasonic Dissectors (UDs) which are primarily developed for laparoscopic surgery found widespread use in thyroid surgery. UDs while closing the nearby vessels cause overheating of neighboring tissues in a 1-3 mm. area. Due to the generated heat UDs might cause nerve injury. We would like to see if usage of UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional thyroidectomy where vessels are first sealed with sutures then cut. To this end patients in both conventional and ultrasonic dissector thyroidectomy arms will be checked for superior laryngeal nerve function the day following operation and six months later.

NCT01812395
Principal SponsorS.B. Konya Education and Research Hospital
Study ContactOsman DOĞRU, M.D.More contacts
Last updated: March 24, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesThyroid DiseasesGoiter

Criteria

1 inclusion criteria required to participate
Patients having thyroidectomy

5 exclusion criteria prevent from participating
History of neck irradiation

History of superior or inferior laryngeal nerve paralysis

Pregnant or lactating women

Previous neck surgery

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Thyroidectomy using harmonic focus (r) device

Group II

Active Comparator
Patients having conventional thyroidectomy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Konya Education and Research Hospital

Meram, Turkey (Türkiye)Open Konya Education and Research Hospital in Google Maps
SuspendedOne Study Center