Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection

NCT06803732 | Recruiting

• 1 other identifier: 2025-KY-095(K)
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Thyroid Diseases; Surgery

Keywords

Lateral neck dissection; Robotic thyroid surgery; Minimally invasive surgery

Outcome Measures

Primary Outcomes (3)

• degree of pain

  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

• Number of participants with recurrent laryngeal nerve injury

  impaired vocal cord mobility confirmed by postoperative laryngoscopy

  through study completion, an average of 1 year

• Number of participants with hypoparathyroidism

  a postoperative parathyroid hormone level of less than 10 pg/ml

  through study completion, an average of 1 year

Study Arms (3)

Robotic group

Patients underwent lateral neck dissection via robotic approach

Other: Observations on postoperative pain intensity

Endoscopic group

Patients underwent lateral neck dissection via endoscopic approach

Other: Observations on postoperative pain intensity

Open group

Patients underwent lateral neck dissection via open approach

Other: Observations on postoperative pain intensity

Interventions

Observations on postoperative pain intensity OTHER

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; Open group; Robotic group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Thyroid Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Endocrine System Diseases

Study Officials

• Ling Zhan, Dr

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Zhan

CONTACT

08615821120972; 15821120972@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CN (1)