Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy

February 12, 2024 updated by: Mansoura University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

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
      • Mansoura, Egypt, 35511
        • Mansoura University Faculty of Medicine

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 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 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: stapler repair group
pharyngeal repair after total laryngectomy was done by using a linear stapler
Procedure: total laryngectomy
pharyngeal repair after total laryngectomy
Active Comparator: conventional repair group
pharyngeal repair after total laryngectomy was done by the conventional method (stitching).
Procedure: total laryngectomy
pharyngeal repair after total laryngectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of pharyngocutaneous fistula after total laryngectomy
Time Frame: four weeks
to assess the effectiveness of pharyngeal repair and healing without pharyngocutaneous fistula
four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 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)

June 1, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 3, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MD.21.06.491

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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