Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-28 @ 4:23 AM
Study NCT ID:
NCT06803732
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of pain', 'timeFrame': 'approximately 4 hours after surgery, on postoperative day 1, postoperative month 1 and postoperative month 3', 'description': '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'}, {'measure': 'Number of participants with recurrent laryngeal nerve injury', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'impaired vocal cord mobility confirmed by postoperative laryngoscopy'}, {'measure': 'Number of participants with hypoparathyroidism', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'a postoperative parathyroid hormone level of less than 10 pg/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lateral neck dissection', 'Robotic thyroid surgery', 'Minimally invasive surgery'], 'conditions': ['Pain, Postoperative', 'Thyroid Diseases', 'Surgery']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent lateral neck dissection via robotic, endoscopic or open approach\n* Clinical diagnosis of differentiated thyroid cancer\n* Clinical diagnosis of metastatic lateral lymph nodes\n\nExclusion Criteria:\n\n* Participants with distant metastasis\n* Participants with history of neck surgery or radiation\n* Participants with vocal fold fixation by preoperative fibrolaryngoscope'}, 'identificationModule': {'nctId': 'NCT06803732', 'briefTitle': 'Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection', 'orgStudyIdInfo': {'id': '2025-KY-095(K)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robotic group', 'description': 'Patients underwent lateral neck dissection via robotic approach', 'interventionNames': ['Other: Observations on postoperative pain intensity']}, {'label': 'Endoscopic group', 'description': 'Patients underwent lateral neck dissection via endoscopic approach', 'interventionNames': ['Other: Observations on postoperative pain intensity']}, {'label': 'Open group', 'description': 'Patients underwent lateral neck dissection via open approach', 'interventionNames': ['Other: Observations on postoperative pain intensity']}], 'interventions': [{'name': 'Observations on postoperative pain intensity', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Endoscopic group', 'Open group', 'Robotic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200233', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Zhan, Doctor', 'role': 'CONTACT', 'email': 'rebecca0428zhan@163.com', 'phone': '08615821120972'}], 'facility': "Shanghai Sixth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ling Zhan', 'role': 'CONTACT', 'email': '15821120972@163.com', 'phone': '08615821120972'}], 'overallOfficials': [{'name': 'Ling Zhan, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 6th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ling Zhan', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}