Minimal Invasiveness of Endoscopic Thyroidectomy

April 9, 2009 updated by: Second Military Medical University

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.

Study Overview

Status

Completed

Conditions

Thyroid Nodule

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

thyroidectomy nodule diagnosed by ultrasound

Exclusion Criteria:

thyroid carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1:endoscopic group patients underwent endoscopic thyroidectomy
2:conventional group patients underwent open thyroidectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Military Medical University

Investigators

Study Director: Ming Qiu, MD., Ph D, SMMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria