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

NCT02768753 | Completed Results DMC

• 1 other identifier: ShandongJJZY-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Papillary Carcinoma; Thyroidectomy

Keywords

Robotic thyroidectomy; Robotic central neck dissection; Axillary bilateral-breast approach; Bilateral axillo-breast approach

Outcome Measures

Primary Outcomes (2)

• Change of VAS Pain Scores for the First 24 Hours

  The visual analogue scale is utilized to assess the postoperative pain change for the first 24 hours.Using a 10cm straight line, one end is marked 0 for "pain free" and the other end is marked 10 for "unbearable pain". The pain intensity of the patient's own feelings was marked on a straight line, and the length from 0 to the marked point represented the pain level of the patient. The evaluation criteria of VAS were as follows: 0 for pain, 3 for mild pain, 4 to 6 for moderate pain and 7 to 10 for severe pain.Lower values represent better outcomes, higher values represent worse outcomes.

  The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded.

• Cosmetic Outcomes

  The satisfaction with cosmetic outcomes was analyzed quantitatively using a scoring system that ranged from 1 to 4(1, extremely; 2, fairly; 3, normal; 4: not at all) that was rated by patients at the outpatient clinic 3 months after the operation.

  3 months after surgery

Secondary Outcomes (2)

• Subjective Voice

  After operation 8 a.m. on the 7th day

• Swallowing Evaluation

  8 a.m. on the 3rd day after operation

Study Arms (2)

The Axillary Bilateral-breast Approach (ABBA) group

EXPERIMENTAL

All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.

Procedure: The Axillary Bilateral-breast Approach

The bilateral Axillo-breast Approach (BABA) group

EXPERIMENTAL

All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.

Procedure: The bilateral Axillo-breast Approach

Interventions

The Axillary Bilateral-breast Approach PROCEDURE

The Axillary Bilateral-breast Approach (ABBA) group

The bilateral Axillo-breast Approach PROCEDURE

The bilateral Axillo-breast Approach (BABA) group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinan Military General Hospital: lead

Study Sites (1)

Department of thyroid and breast surgery, General Hospital of Jinan Military Area

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Results Point of Contact

• Title: Dr.Qing Qing He，Dr.Gao Feng Ni
• Organization: General Hospital of Jinan Military Area

m15653853675@163.com

15653853675

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 27, 2019
• Results First Posted: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)