Pain, PostoperativeNCT06803732
Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection
An observational study of Pain, Postoperative and Thyroid Diseases, run by Shanghai 6th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Postoperative, Thyroid Diseases, Surgery
- What is being tested?
- Observations on postoperative pain intensity
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients underwent lateral neck dissection via robotic, endoscopic or open approach
- Clinical diagnosis of differentiated thyroid cancer
- Clinical diagnosis of metastatic lateral lymph nodes
Who cannot join
- Participants with distant metastasis
- Participants with history of neck surgery or radiation
- Participants with vocal fold fixation by preoperative fibrolaryngoscope
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Ling Zhan, Doctor, 08615821120972, rebecca0428zhan@163.com
About this study
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
- Being tested
- Observations on postoperative pain intensity
- Keywords
- Lateral neck dissection, Robotic thyroid surgery, Minimally invasive surgery
- Medical subject headings
- Pain, Postoperative, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observations on postoperative pain intensityOther
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
| Study group | Role | What they receive |
|---|---|---|
| Robotic group | Patients underwent lateral neck dissection via robotic approach Receives: Other: Observations on postoperative pain intensity | |
| Endoscopic group | Patients underwent lateral neck dissection via endoscopic approach Receives: Other: Observations on postoperative pain intensity | |
| Open group | Patients underwent lateral neck dissection via open approach Receives: Other: Observations on postoperative pain intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion, an average of 1 year
Number of participants with hypoparathyroidism
a postoperative parathyroid hormone level of less than 10 pg/ml
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Zhan, Shanghai 6th People's Hospital
- Investigators
- Ling Zhan, Dr, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803732
- Sponsor's protocol ID
- 2025-KY-095(K)
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection
- ClinicalTrials.gov ID
- NCT06803732
- Acronym / sponsor ID
- 2025-KY-095(K)
- Conditions
- Pain, Postoperative, Thyroid Diseases, Surgery
- Keywords
- Lateral neck dissection, Robotic thyroid surgery, Minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robotic group | – | Other: Observations on postoperative pain intensityPatients underwent lateral neck dissection via robotic approach |
| Endoscopic group | – | Other: Observations on postoperative pain intensityPatients underwent lateral neck dissection via endoscopic approach |
| Open group | – | Other: Observations on postoperative pain intensityPatients underwent lateral neck dissection via open approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients underwent lateral neck dissection via robotic, endoscopic or open approach
- Clinical diagnosis of differentiated thyroid cancer
- Clinical diagnosis of metastatic lateral lymph nodes
Key exclusion criteria (3 listed)
- Participants with distant metastasis
- Participants with history of neck surgery or radiation
- Participants with vocal fold fixation by preoperative fibrolaryngoscope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observations on postoperative pain intensitypain 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 | Other | Endoscopic group, Open group, Robotic group |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ling Zhan, Dr principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Thyroid Diseases, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Zhan (08615821120972, 15821120972@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of pain (time frame: approximately 4 hours after surgery, on postoperative day 1, postoperative month 1 and postoperative month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.