Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy

Mansoura University58 enrolled

Overview

This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Malignant Tumor of the Larynx

Interventions

total laryngectomyPROCEDURE

pharyngeal repair after total laryngectomy

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Mansoura University faculty of Medicine

Al Mansurah, Egypt

Outcomes

Primary Outcomes

incidence of pharyngocutaneous fistula after total laryngectomy

to assess the effectiveness of pharyngeal repair and healing without pharyngocutaneous fistula

Time frame: four weeks

Secondary Outcomes

assessment of the swallowing function after surgery

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)

Time frame: 6 months

Data from ClinicalTrials.gov

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