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

September 8, 2026 updated by: Dongsik Bae, Inje University

Prospective Randomized Controlled Study on Mini-flap Bilateral Axillo-breast Approach Robotic Thyroidectomy : Effect on Postoperative Pain and Sensation

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

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

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

19 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional flap
BABA robotic-thyroidectomy that using conventional flap
Procedure: Conventional flap
Conventional flap BABA robotic-thyroidectomy creates flaps up to the thyroid cartilage
Active Comparator: Mini-flap
BABA robotic-thyroidectomy that using Mini-flap
Procedure: Mini-flap
Mini-flap BABA robotic-thyroidectomy creates flaps up to the cricoid cartilage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain measured using a visual analog scale
Time Frame: 2, 24, 48, and 72 hours after surgery
Postoperative pain was assessed using a visual analog scale ranging from 0 to 10, with higher scores indicating greater pain.
2, 24, 48, and 72 hours after surgery
Rescue analgesic use
Time Frame: 2, 24, 48, and 72 hours after surgery
Number of additional doses of ketorolac administered for postoperative pain.
2, 24, 48, and 72 hours after surgery
Change from baseline in sensory function as measured by Semmes-Weinstein monofilaments
Time Frame: 1 day before surgery and 1, 6 and 12 months after surgery
Sensory function was assessed using six Semmes-Weinstein monofilaments to measure pressure detection thresholds in four predefined anatomical regions: the superior anterior neck, inferior anterior neck, right anterior chest, and left anterior chest.
1 day before surgery and 1, 6 and 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of vocal cord palsy
Time Frame: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
Check vocal cord palsy that means injury of the recurrent laryngeal nerve with a direct laryngoscope
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
Time Frame: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
check PTH (parathyroid hormone) level
before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery

Collaborators and Investigators

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

Sponsor

Inje University

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 (Actual)

January 24, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-10-014-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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