Malignant Tumor of the Larynx
Conditions
Brief summary
This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.
Interventions
PROCEDUREtotal laryngectomy
pharyngeal repair after total laryngectomy
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All consecutive patients undergoing total laryngectomy for advanced laryngeal carcinoma in the study duration .
Exclusion criteria
* Infiltration of the safety margins proved by postoperative histopathology . * Patients with tumor extension to the tongue base, or the hypopharynx . * Patients who are unfit for surgery . * Patients refusal to surgical treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of pharyngocutaneous fistula after total laryngectomy | four weeks | to assess the effectiveness of pharyngeal repair and healing without pharyngocutaneous fistula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assessment of the swallowing function after surgery | 6 months | swallowing was evaluated subjectively by applying the Sydney Swallow Questionnaire, (SSQ) and was evaluated objectively by performing modified barium swallow and functional endoscopic evaluation of swallowing (FEES) |
Countries
Egypt
Outcome results
None listed