Minimal Invasiveness of Endoscopic Thyroidectomy

This study has been completed.
Sponsor:
Information provided by:
Second Military Medical University
ClinicalTrials.gov Identifier:
NCT00877630
First received: April 7, 2009
Last updated: April 9, 2009
Last verified: April 2009
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minimal Invasiveness of Endoscopic Thyroidectomy

Resource links provided by NLM:


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

Additional relevant MeSH terms:
Thyroid Nodule
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on August 21, 2014