Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy

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

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Key information

Conditions

Malignant Tumor of the Larynx Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University faculty of Medicine

Al Mansurah, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total laryngectomy

Procedure

pharyngeal repair after total laryngectomy

Primary outcomes

incidence of pharyngocutaneous fistula after total laryngectomy

Time frame: four weeks

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

Secondary outcomes

assessment of the swallowing function after surgery

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Linear Stapler Versus Conventional Repair of the Pharynx After Total Laryngectomy: Functional and Oncological Outcomes

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Feb 13, 2024
Registry last updated: Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed