Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy (ET)

April 18, 2011 updated by: Second Military Medical University

Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy

The purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To create a working place in the chest wall is an inevitable step of endoscopic thyroidectomy. Large subcutaneous area was considered a drawback of endoscopic thyroidectomy. The purpose of this study is to investigate whether subcutaneous dissection area has influence on clinical outcome of endoscopic thyroidectomy, such as post-operative pain, complication rate and post-operative discomfort.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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
      • Shanghai, Shanghai, China, 200003
        • Department of General Surgery, Changzheng 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

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • thyroid nodule diagnosed by ultrasound
  • willing to undergo endoscopic thyroidectomy

Exclusion Criteria:

  • conversion to open surgery
  • unwilling to join the research

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: standard
3 trocars are needed. two in the circumareolar region and one in the parasternal region. the dissection area begins from the trocar site and extends to the neck.
Procedure: endoscopic thyroidectomy
endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.
Other Names:
  • limited flap dissection endoscopic thyroidectomy
Experimental: limited dissection
the dissection is reduced by creating a long tunnel from the trocar site and the dissection area confined in the upper chest wall and in the neck.
Procedure: endoscopic thyroidectomy
endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.
Other Names:
  • limited flap dissection endoscopic thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative pain
Time Frame: 24h post-operation
24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale)
24h post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with adverse effect
Time Frame: within 3 months after surgery
record how many patients had adverse effects(eg. bruise, seroma, hematoma, hoarseness,hypocalciemia)
within 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 Chair: ming qiu, MD, Changzheng hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 18, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMMU-2011-ET-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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