NCT07229859

Completed

Robotic Surgery Via Bilateral Axillo-breast Approach for Rel...

Ruijin Hospital Source

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Other study identifiers

Sponsor study identifier

RHEC-D-2021-024

Study Type

observational

Actual enrollment (reported)

332

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2018

Actual (reported)

Primary Completion

December 31, 2022

Actual (reported)

Study Completion

January 1, 2025

Actual (reported)

Brief Summary

The goal of this observational study is to learn the efficacy, cosmetic effectiveness and safety of robotic modified radical neck dissection in well-selected cases, through direct comparison with conventional open surgery in low-risk papillary thyroid carcinoma with lateral cervical lymph node metastasis. The main questions it aims to answer are: Does robotic neck dissection provide tumor clearance equivalent to that of the conventional open approach? How does the postoperative complication rate of the robotic technique compare with open surgery? Are patients satisfied with the cosmetic appearance of the wound following robotic neck dissection? Researchers will compare robotic surgery with conventional open surgery to see if it has the same efficacy, cosmetic effectiveness and safety. Participants' postoperative recovery will be followed up, and they will provide pain scores and rate their cosmetic satisfaction with the wound.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 332 participants
Study completion date: January 1, 2025
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2018
Actual (reported)
Primary Completion
December 31, 2022
Actual (reported)
Study Completion
January 1, 2025
Actual (reported)
First Submitted
November 13, 2025
Actual (reported)
First Posted
November 17, 2025
Actual (reported)

Last Updated: November 17, 2025
Status Verified: October 2025
Last Update Submitted: November 13, 2025

Conditions

Differentiated Thyroid Cancer (DTC)Robotic Assistance

Outcome Measures

Primary Outcomes (2)

Number of retrieved Lymph nodes
From enrollment to the end of surgical procedure
postoperative complications
Vocal cord paralysis; hypocalcemia; spinal accessory nerve injury; chyle leakage
From enrollment to the end of treatment at 1 year

Study Arms (2)

robotic modified radical neck dissection group

open modified radical neck dissection group

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Study population came from a single high-volume thyroid center, with all surgeries performed by the same surgeon.

You may qualify if:

(1) PTC with lateral LN metastasis confirmed by fine needle aspiration (FNA) biopsy;

Sponsors & Collaborators

Ruijin Hospital
Otherlead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Enrollment

332 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Target Duration: 3 Years
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

January 1, 2018

Actual (reported)

NCT01788982

Nintedanib(BIBF1120) in Thyroid Cancer

Phase 2Completed

NCT02041260

A Phase II Trial of Cabozantinib for the Treatment of Radioiodine (RAI)-Refractory Differentiated Thyroid Carcinoma (DTC) in the First-line Setting

Phase 2Unknown

(2) maximum tumor size \< 3 cm;

(3) without extrathyroidal extension;

(4) metastatic LNs in unilateral levels II, III, IV and/or V;

(5) number of suspicious metastatic LNs based on preoperative ultrasonography \< 5;

(6) maximum metastatic LN diameter \< 3 cm.

You may not qualify if:

(1) metastatic LNs in level I or VII;
(2) metastatic LNs fused with each other or fixed in the neck or extra-nodal extension;
(3) history of neck surgery or radiation therapy;
(4) extranodal extension;
(5) the presence of TERT mutation.

Contact the study team to confirm eligibility.

Primary Completion

December 31, 2022

Actual (reported)

Study Completion

January 1, 2025

Actual (reported)

Last Updated

November 17, 2025

Record last verified: 2025-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07229859
Data provider: ClinicalTrials.gov
Source updated: 2025-11-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:06 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

robotic modified radical neck dissection group

open modified radical neck dissection group

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations