Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy

NCT ID: NCT01338597

Last Updated: 2011-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Thyroid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

endoscopic thyroidectomy

Intervention Type PROCEDURE

endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.

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.

Group Type EXPERIMENTAL

endoscopic thyroidectomy

Intervention Type PROCEDURE

endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.

Interventions

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endoscopic thyroidectomy

endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.

Intervention Type PROCEDURE

Other Intervention Names

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limited flap dissection endoscopic thyroidectomy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* conversion to open surgery
* unwilling to join the research
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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changzheng hospital

Principal Investigators

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ming qiu, MD

Role: STUDY_CHAIR

Changzheng Hospital

Locations

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Department of General Surgery, Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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wei zhang, MD

Role: CONTACT

-8621-81885802

ming qiu, MD

Role: CONTACT

8621-81885801

Facility Contacts

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wei zhang, MD

Role: primary

8621-81885802

ming qiu, MD

Role: backup

8621-81885801

References

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Wang M, Zhang T, Mao Z, Dong F, Li J, Lu A, Hu W, Zang L, Jiang Y, Zheng M. Effect of endoscopic thyroidectomy via anterior chest wall approach on treatment of benign thyroid tumors. J Laparoendosc Adv Surg Tech A. 2009 Apr;19(2):149-52. doi: 10.1089/lap.2008.0296.

Reference Type RESULT
PMID: 19361288 (View on PubMed)

Other Identifiers

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SMMU-2011-ET-1

Identifier Type: -

Identifier Source: org_study_id

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