Prophylactic pectoralis major flap to compensate for increased risk of pharyngocutaneous fistula in laryngectomy patients with low skeletal muscle mass
- Conditions
- Patients who are planned for TL (advanced stage primary laryngeal or hypopharyngeal cancer, salvage patients with recurrent disease after failure of initial organ preserving treatment, dysfunctional larynx)
- Registration Number
- NL-OMON26043
- Lead Sponsor
- MC Utrecht
- Brief Summary
.A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 276
Inclusion Criteria
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.
Exclusion Criteria
- Planned for TL with PMMC for reconstruction of the pharynx.
- Major CT or MRI artefacts, impeding accurate muscle tissue identification on CT imaging.
- Interval between TL and imaging > 2 months.
- Concurrent treatment with chemotherapy for a previously diagnosed head and neck carcinoma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this randomized clinical trial is the PCF rate following TL in patients with low SMM with or without PMMF as onlay for reinforcement.
- Secondary Outcome Measures
Name Time Method Secondary outcomes of this study are hospital stay, shoulder- and neck function, swallowing function, voice quality, quality of life, patients’ perspective, and costs.