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

November 18, 2025 updated by: Mansoura University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35511
        • Faculty of Medicine, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cervical fascia flap group
Procedure: Total laryngectomy
pharyngeal repair after total larygectomy
Active Comparator: conventional repair group
Procedure: Total laryngectomy
pharyngeal repair after total larygectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of pharyngocutaneous fistula after total laryngectomy
Time Frame: Four weeks
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective assessment of the swallowing function after surgery
Time Frame: three months
swallowing was evaluated subjectively by applying the Eating Assessment Tool (EAT-10) questionnaire
three months
objective assessment of the swallowing function after surgery
Time Frame: Three months
swallowing was evaluated objectively by functional endoscopic evaluation of swallowing (FEES)
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.24.08.2855

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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