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N/A N=60 Randomized Double-blind Treatment

Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy

Thyroid Papillary Carcinoma · Thyroidectomy

Bottom Line

View on ClinicalTrials.gov: NCT02768753 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change of VAS Pain Scores for the First 24 Hours — 2.13; 2.33 score

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
The Axillary Bilateral-breast Approach (Procedure); The bilateral Axillo-breast Approach (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Jinan Military General Hospital
Primary completion
Apr 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change of VAS Pain Scores for the First 24 Hours		 2.13; 2.33 —
PRIMARY
Cosmetic Outcomes		 3.17; 3.90 —
SECONDARY
Subjective Voice		 10.27; 10.70 —
SECONDARY
Swallowing Evaluation		 1.23; 1.27 —

Summary

The purpose of this study is to compare the therapeutic effects between the axillary bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic thyroidectomy.To explore the efficacy, safety, cosmetic results and clinical value by the two approaches.

Eligibility Criteria

Inclusion Criteria

  • the initial surgery
  • preoperative needle aspiration biopsy of thyroid cancer, and the diameter of no more than 1cm, no lateral neck lymph node metastasis
  • the tumor is confined to the thyroid membrane, not invading trachea and recurrent laryngeal nerve
  • intraoperative frozen section diagnosis of thyroid cancer
  • the patient informed consent.

Exclusion Criteria

  • high-frequency ultrasound preoperative tumor diameter greater than 1cm, or lateral neck lymph node metastasis in patients
  • there had been a history of thyroid surgery or neck radiation therapy
  • pregnant or lactating women
  • with severe Hashimoto's thyroiditis, thyroid volume greater than II °
  • coagulation disorders, hyperthyroidism or hypothyroidism patients
  • sternal goiter.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02768753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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