Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection

March 19, 2025 updated by: Ling Zhan, Shanghai 6th People's Hospital
Postoperative pain is a good indicator to confirm the advantages of the surgical methods in the era of minimally invasive surgery. Lateral neck dissection requires extensive dissection which may leads to postoperative numbness and pain. Robotic thyroid surgery has the advantage of precise and careful dissection and avoid the L-shape incision in the open approach. The study aims to explore the pain intensity and severity of lateral neck dissection on operation day, postoperative month 1 and postoperative month 3 among the robotic, endoscopic and open approach.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with FNA proven differentiated thyroid cancer and metastatic lateral lymph nodes, underwent lateral neck dissection via robotic, endoscopic or open approach. Patients were well informed about the potential benefits and risks of robotic, endoscopic and open approach. Patient consented for us to use perioperative data.

Description

Inclusion Criteria:

  • Patients underwent lateral neck dissection via robotic, endoscopic or open approach
  • Clinical diagnosis of differentiated thyroid cancer
  • Clinical diagnosis of metastatic lateral lymph nodes

Exclusion Criteria:

  • Participants with distant metastasis
  • Participants with history of neck surgery or radiation
  • Participants with vocal fold fixation by preoperative fibrolaryngoscope

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Robotic group
Patients underwent lateral neck dissection via robotic approach
Other: Observations on postoperative pain intensity
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain on operation day, postoperative day 1, postoperative month 1, postoperative month 3
Endoscopic group
Patients underwent lateral neck dissection via endoscopic approach
Other: Observations on postoperative pain intensity
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain on operation day, postoperative day 1, postoperative month 1, postoperative month 3
Open group
Patients underwent lateral neck dissection via open approach
Other: Observations on postoperative pain intensity
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain on operation day, postoperative day 1, postoperative month 1, postoperative month 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with recurrent laryngeal nerve injury
Time Frame: through study completion, an average of 1 year
impaired vocal cord mobility confirmed by postoperative laryngoscopy
through study completion, an average of 1 year
Number of participants with hypoparathyroidism
Time Frame: through study completion, an average of 1 year
a postoperative parathyroid hormone level of less than 10 pg/ml
through study completion, an average of 1 year
degree of pain
Time Frame: approximately 4 hours after surgery, on postoperative day 1, postoperative month 1 and postoperative month 3
pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain
approximately 4 hours after surgery, on postoperative day 1, postoperative month 1 and postoperative month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Investigators

  • Principal Investigator: Ling Zhan, Dr, Shanghai 6th People's Hospital

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 (Actual)

November 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-KY-095(K)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data are available on request due to privacy or other restrictions. The data that support the findings of this study are available on request from Ling Zhan. The data are not publicly available due to them containing information that could compromise research participant privacy.

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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