Skip to main content
OpenTrials
Active, not recruiting

NCT Number: NCT05216718

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Thyroid Nodule Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dong sik Bae

Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini-flap

Procedure

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

conventional flap

Procedure

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

Primary outcomes

  1. 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. Rescue analgesic use

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

    Number of additional doses of ketorolac administered for postoperative pain.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jan 31, 2022
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.