The Recovery Profiles After Robotic or Open Thyroidectomy | NCT03222700

Studies
The Recovery Profiles After Robotic or Open Thyroidectomy

NCT03222700

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jul 19, 2017Actual

Enrollment

104Estimated

Phase

Not provided

Conditions

Postoperative Sorethroat
Postoperative Pain

Interventions

surgical procedure

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Aug 2018Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Jul 12, 2017

First Submission Date that Met QC Criteria

Jul 17, 2017

First Posted Date

Jul 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2017

Last Update Posted Date

Jul 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In the present study, The investigators investigated the effect of surgical methods on the recovery of patients after robotic surgery and open thyroidectomy

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
robotic thyroidectomy group			Procedure: surgical procedure
open thyroidectomy group			Procedure: surgical procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgical procedure	Procedure	In robotic thyroidectomy group, patients are received surgery using robotic system. In open thyroidectomy group, patients are received conventional open surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative sore throat	none, mild, moderate, severe	postoperative 1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing robotic thyroidectomy or open conventional thyroidectomy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yeji Lee, Pf	Contact	82317877499		ladydaisy82@naver.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ah-young Oh	Recruiting	Seongnam-si	Gyeonggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided