Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy
Not Applicable
Completed
- Conditions
- Malignant Tumor of the Larynx
- Interventions
- Procedure: total laryngectomy
- Registration Number
- NCT06256263
- Lead Sponsor
- Mansoura University
- Brief Summary
This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional repair group total laryngectomy pharyngeal repair after total laryngectomy was done by the conventional method (stitching). stapler repair group total laryngectomy pharyngeal repair after total laryngectomy was done by using a linear stapler
- Primary Outcome Measures
Name Time Method incidence of pharyngocutaneous fistula after total laryngectomy four weeks to assess the effectiveness of pharyngeal repair and healing without pharyngocutaneous fistula
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Mansoura University faculty of Medicine
🇪🇬Mansoura, Egypt