*Prophylactic pectoralis major flap to compensate for increased risk of pharyngocutaneous fistula in laryngectomy patients with low skeletal muscle mass*
- Conditions
- laryngectomylow skeletal muscle mass10019190
- Registration Number
- NL-OMON52422
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 246
• Planned for TL
• Eighteen years of age or older, and able to exercise their free will.
• Sufficient understanding of the Dutch language to give informed consent.
- Planned for TL with pharyngectomy and reconstruction of the pharynx with
PMMC.
- Planned TL with pharyngectomy and reconstruction with jejunal flap or gastric
pull-up.
- Planned TL after treatment with chemoradiotherapy (cisplatin/carboplatin) for
a previously diagnosed head and neck carcinoma
- Major (FDG-PET/)CT or MRI artefacts, impeding accurate muscle tissue
identification on
imaging.
- Interval between TL and imaging > 2 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method