Minimal Invasiveness of Endoscopic Thyroidectomy

This study has been completed.

First Received: April 7, 2009 Last Updated: April 9, 2009 History of Changes

Sponsored by:	Second Military Medical University
Information provided by:	Second Military Medical University
ClinicalTrials.gov Identifier:	NCT00877630

Purpose

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.

Condition
Thyroid Nodule

MedlinePlus related topics: Endoscopy Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Minimal Invasiveness of Endoscopic Thyroidectomy

Further study details as provided by Second Military Medical University:

Primary Outcome Measures:

Serum IL-6 and CRP levels before and after operation [ Time Frame: 0, 2, 12, 24, 48 hours after surgery ] [ Designated as safety issue: Yes ]
Visual Analogue Scale (VAS) score [ Time Frame: 2, 12, 24, 48 hours after surgery ] [ Designated as safety issue: Yes ]
Cosmetic outcomes after surgery [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]

Study Start Date:	September 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
1:endoscopic group patients underwent endoscopic thyroidectomy
2:conventional group patients underwent open thyroidectomy

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

thyroidectomy nodule diagnosed by ultrasound

Exclusion Criteria:

thyroid carcinoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877630

Locations

China
Minimally Invasive Surgical Center of Changzhang Hospital
Shanghai, China, 200003

Sponsors and Collaborators

Second Military Medical University

Investigators

Study Director:

Ming Qiu, MD., Ph D

SMMU

More Information

No publications provided

Responsible Party:	Changzheng Hospital affiliated to SMMU ( Ming Qiu/Minimally Invasive Surgical Center )
Study ID Numbers:	SMMU-2-2009-2
Study First Received:	April 7, 2009
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00877630 History of Changes
Health Authority:	China: Ethics Committee

Study placed in the following topic categories:

Thyroid Neoplasms
Thyroid Nodule
Head and Neck Neoplasms
Endocrine System Diseases

Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Thyroid Neoplasms
Thyroid Nodule

Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009