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Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe

NCT ID: NCT05216718

Last Updated: 2022-01-31

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-24

Study Completion Date

2023-12-01

Brief Summary

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In this study, a randomized controlled study was conducted between two groups of 40 recipients of conventional flap during BABA robotic-thyroidectomy and 40 recipients of Mini-flap method during BABA robotic-thyroidectomy. In this study, we tried to determine whether the use of Mini-flap can reduce sensory loss and pain after BABA robotic-thyroidectomy.

Detailed Description

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Conditions

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Thyroid Nodule

Keywords

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Mini-flap Bilateral axillo-breast approach Da vinci Robot-assisted thyroid surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Conventional flap

BABA robotic-thyroidectomy that using conventional flap

Group Type EXPERIMENTAL

Conventional flap

Intervention Type PROCEDURE

Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage

Mini-flap

BABA robotic-thyroidectomy that using Mini-flap

Group Type ACTIVE_COMPARATOR

Mini-flap

Intervention Type PROCEDURE

Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage

Interventions

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Mini-flap

Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage

Intervention Type PROCEDURE

Conventional flap

Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* subjects who will have thyroid surgery
* subjects who has no evidence of lymph node metastasis on palpation and imaging (cN0)
* subjects who has thyroid nodule under 4cm (\<cT2)
* subjects who has no distant metastasis (M0)

Exclusion Criteria

* subjects who has clinical evidence of lymph node metastasis (cN1a or cN1b)
* subjects who has both thyroid nodule
* subjects who underwent any radiotherapy on neck
* subjects who has primary hyperparathyroidism
* subjects who underwent head and neck surgery
* subjects who disagree to do this trial
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Dongsik Bae

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dong sik Bae

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2021-10-014-001

Identifier Type: -

Identifier Source: org_study_id