Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection for patients with head and neck cancer - A Prospective Multicenter Clinical Study
- Conditions
- Head and neck cancer
- Registration Number
- JPRN-UMIN000032336
- Lead Sponsor
- Yokohama City University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Not provided
1)Patients who underwent the ipsilateral neck dissection or radiotherapy before. 2)Patients who registered other clinical trial (intervention study or Japanese registration trial) for head and neck cancer before. 3)Patients with infections requiring systematic treatment 4)Multiple malignancies except for carcinoma in situ and intramucosal cancer. 5)uncontrolable diabetes 6)severe heart disease such as myocardial infarction within six months and unstable angina. 7)uncontrolabel hypertension 8)pulmonary disease with over class 3 in American Society of Anesthesiologists physical status classification 9)Patients with a history of hypersensitivity for polyglycolic acid and collagen. 10)Patients with continuous systemic administration of steroid or immunosuppressant 11)Patients with the possibility of pregnancy or pregnancy 12)Patients who are unable oral administration of mecobalamin 13)Patients with gastrointestinal disorders inhibiting the absorption of mecobalamin 14)Patients with mental illness, alcoholism,drug addiction affecting the compliance with the clinical trial. 15)Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the active range of shoulder abductive motion at postoperative after 24 months
- Secondary Outcome Measures
Name Time Method