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

Inje University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Thyroid Nodule

Interventions

Mini-flapPROCEDURE

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

Conventional flapPROCEDURE

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Dong sik Bae

Busan, South Korea

Outcomes

Primary Outcomes

Change from baseline in pain, as measured by the Visual Analog Score(VAS)

Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains

Time frame: 2, 24, 48, 72 hours after surgery

change from baseline in pain, as measured by the number of analgesics uses

number of analgesics(additional ketorolac uses)

Time frame: 2, 24, 48, 72 hours after surgery

change from baseline in Sensory change, as measured by the monofilaments

Six monofilaments were used to measure the pressure threshold of the 2 chest zones and 2 neck zones

Time frame: 1 day before surgery, 1, 3 months after surgery

Secondary Outcomes

Incidence of vocal cord palsy

Check vocal cord palsy that means injury of the recurrent laryngeal nerve with a direct laryngoscope

Time frame: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery

change from baseline in Hypoparathyroidism, as measured by parathyroid hormone level

check PTH (parathyroid hormone) level

Time frame: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery

Data from ClinicalTrials.gov

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