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

January 27, 2022 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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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

Genders Eligible for Study

All

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
  • 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
Change from baseline in pain, as measured by the Visual Analog Score(VAS)
Time Frame: 2, 24, 48, 72 hours after surgery
Visual Analog Score for pain, range from 0 to 10, Higher the values represents more pains
2, 24, 48, 72 hours after surgery
change from baseline in pain, as measured by the number of analgesics uses
Time Frame: 2, 24, 48, 72 hours after surgery
number of analgesics(additional ketorolac uses)
2, 24, 48, 72 hours after surgery
change from baseline in Sensory change, as measured by the monofilaments
Time Frame: 1 day before surgery, 1, 3 months after surgery
Six monofilaments were used to measure the pressure threshold of the 2 chest zones and 2 neck zones
1 day before surgery, 1, 3 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 (ANTICIPATED)

January 24, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 1, 2023

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)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

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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