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Role of Cervical Fascia Flap in Decreasing the Incidence of Pharyngocutaneous Fistula After Total Laryngectomy

Role of Cervical Fascia Flap in Decreasing the Incidence of Pharyngocutaneous Fistula After Total Laryngectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07241611
Enrollment
50
Registered
2025-11-21
Start date
2024-07-01
Completion date
2025-09-30
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumor of the Larynx

Brief summary

This study was conducted to evaluate the potential role of using the cervical fascia flap over the pharyngeal closure line to enhance healing and subsequently to decrease the incidence of pharyngocutaneous fistula after total laryngectomy.

Interventions

PROCEDURETotal laryngectomy

pharyngeal repair after total larygectomy

Sponsors

Mansoura University
Lead SponsorOTHER

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 who will undergo total laryngectomy for advanced laryngeal carcinoma in the study duration.

Exclusion criteria

* Presence of extra-laryngeal extension. * Patients undergoing partial pharyngectomy. * Previous neck irradiation. * Previous neck surgery. * Patients' refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
incidence of pharyngocutaneous fistula after total laryngectomyFour weeks

Secondary

MeasureTime frameDescription
subjective assessment of the swallowing function after surgerythree monthsswallowing was evaluated subjectively by applying the Eating Assessment Tool (EAT-10) questionnaire
objective assessment of the swallowing function after surgeryThree monthsswallowing was evaluated objectively by functional endoscopic evaluation of swallowing (FEES)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026