Minimal Invasiveness of Endoscopic Thyroidectomy | NCT00877630

Studies
Minimal Invasiveness of Endoscopic Thyroidectomy

NCT00877630

Sponsor

Second Military Medical University

Status

Completed

Last Update Posted

Apr 10, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Thyroid Nodule

Interventions

Not provided

Countries

China

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

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Apr 7, 2009

First Submission Date that Met QC Criteria

Apr 7, 2009

First Posted Date

Apr 8, 2009Estimated

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

Apr 9, 2009

Last Update Posted Date

Apr 10, 2009Estimated

Description Module

Brief Summary

The investigators had performed more than 250 cases of breast approach endoscopic thyroidectomy (BAET). The goal of this study is to evaluate whether BAET could be a minimally invasive procedure under the expert's hands.

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

Not provided

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

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1:endoscopic group		patients underwent endoscopic thyroidectomy
2:conventional group		patients underwent open thyroidectomy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum IL-6 and CRP levels before and after operation		0, 2, 12, 24, 48 hours after surgery
Visual Analogue Scale (VAS) score		2, 12, 24, 48 hours after surgery
Cosmetic outcomes after surgery		3 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

thyroidectomy nodule diagnosed by ultrasound

Exclusion Criteria:

thyroid carcinoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients admitted in the ward who are diagnosed with thyroid nodule and will undergo thyroidectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ming Qiu, MD., Ph D	SMMU	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minimally Invasive Surgical Center of Changzhang Hospital		Shanghai		200003	China

Condition Browse Module

MeSH Terms

ID	Term
D016606	Thyroid Nodule

Ancestor Terms

ID	Term
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided