Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShanghai 6th People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients underwent lateral neck dissection via robotic, endoscopic or open approach
Clinical diagnosis of differentiated thyroid cancer
Clinical diagnosis of metastatic lateral lymph nodes
Disqualifiers
Participants with distant metastasis
Participants with history of neck surgery or radiation
Participants with vocal fold fixation by preoperative fibrolaryngoscope
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observations on postoperative pain intensity
Other interventionpain 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
Treatment groups
600 Participants
are divided into 3 treatment groupsGroup A: Robotic group1 intervention
Group B: Endoscopic group1 intervention
Group C: Open group1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
approximately 4 hours after surgery, on postoperative day 1, postoperative month 1 and postoperative month 32
Number of participants with recurrent laryngeal nerve injury
impaired vocal cord mobility confirmed by postoperative laryngoscopy
Time frame
through study completion, an average of 1 year3
Number of participants with hypoparathyroidism
a postoperative parathyroid hormone level of less than 10 pg/ml
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov