NCT03222700

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

1.9 years

First QC Date

July 12, 2017

Last Update Submit

July 17, 2017

Conditions

Postoperative SorethroatPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • postoperative sore throat

    none, mild, moderate, severe

    postoperative 1 hour

Study Arms (2)

robotic thyroidectomy group

Procedure: surgical procedure

open thyroidectomy group

Procedure: surgical procedure

Interventions

surgical procedurePROCEDURE

In robotic thyroidectomy group, patients are received surgery using robotic system. In open thyroidectomy group, patients are received conventional open surgery.

open thyroidectomy grouprobotic thyroidectomy group

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing robotic thyroidectomy or open conventional thyroidectomy

You may qualify if:

  • Patients undergoing robotic thyroidectomy or open conventional thyroidectomy
  • Adults 19 to 70 years of age
  • American Society of Anesthesiologists Physical grade 1-2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ah-young Oh

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Yeji Lee, Pf

CONTACT

82317877499ladydaisy82@naver.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 19, 2017

Study Start

September 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

KR(1)