- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03222700
The Recovery Profiles After Robotic or Open Thyroidectomy
July 17, 2017 updated by: Seoul National University Hospital
In the present study, The investigators investigated the effect of surgical methods on the recovery of patients after robotic surgery and open thyroidectomy
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
104
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- Recruiting
- Ah-young Oh
-
Contact:
- Yeji Lee, Pf
- Phone Number: 82317877499
- Email: ladydaisy82@naver.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing robotic thyroidectomy or open conventional thyroidectomy
Description
Inclusion Criteria:
- Patients undergoing robotic thyroidectomy or open conventional thyroidectomy
- Adults 19 to 70 years of age
- American Society of Anesthesiologists Physical grade 1-2
Exclusion Criteria:
- Patients who underwent surgery on the neck and in the laryngeal area before
- Patients who do not understand or can not express pain scale
- Patients with sore throat and cough before surgery
- If intubation is difficult or repeated intubation is performed
- Patients who are using opioids or analgesics as chronic agents.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
robotic thyroidectomy group
|
In robotic thyroidectomy group, patients are received surgery using robotic system.
In open thyroidectomy group, patients are received conventional open surgery.
|
|
open thyroidectomy group
|
In robotic thyroidectomy group, patients are received surgery using robotic system.
In open thyroidectomy group, patients are received conventional open surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative sore throat
Time Frame: postoperative 1 hour
|
none, mild, moderate, severe
|
postoperative 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2016
Primary Completion (ANTICIPATED)
August 1, 2018
Study Completion (ANTICIPATED)
August 1, 2018
Study Registration Dates
First Submitted
July 12, 2017
First Submitted That Met QC Criteria
July 17, 2017
First Posted (ACTUAL)
July 19, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 19, 2017
Last Update Submitted That Met QC Criteria
July 17, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1606/351-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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