Outcome of Resection Anastomosis and Long Term Stenting With Montgomery Tube Operations in Management of Grade 3 Benign Laryngotracheal Stenosis

July 7, 2024 updated by: Awatef Mahmoud Ahmed, Sohag University

Laryngotracheal stenosis is a challenging problem in the field of laryngology. In the majority of patients, acquired stenosis of the larynx and trachea is due to accidental trauma, prolonged intubations, or tracheostomy. Congenital stenosis, caustic injury, and granulomatous diseases are also etiological factors in laryngotracheal stenosis (Grenier PA et al, 2009).

Tracheal stenosis can occur following tracheostomy or endotracheal intubation with inappropriate cuff pressure. It is due to pressure necrosis at the site of the cuff. Initially, there is inflammation of the damaged mucosa with increased secretion and secondary infection. Prolonged ischemia and secondary infection cause necrosis of the tracheal wall and exposure and sequestration of the cartilaginous rings. This damage results in the formation of granulation tissue and collapse of the tracheal wall (Satish Nair et al, 2014).

The tracheal stenosis is classified as simple, which is a soft, short segment web-like narrowing often limited to the mucosa only or complex stenosis, which is a hard, long-segment stricture with destruction of tracheal cartilages and fibrosis. Post tracheostomy stenosis occurs most commonly at the stoma site or less commonly at the site where the tip of the tube has impinged on the tracheal mucosa (Liu J et al, 2015).

The symptoms are generally insidious. Most arise 1 to 6 weeks after extubation, and early symptoms are often not recognized. The most common symptoms include shortness of breath, cough, recurrent pneumonia, wheezing, stridor, and cyanosis over time. Dyspnea is often the symptom until the tracheal diameter is 50% smaller than normal. When the tracheal diameter is 25% of its normal size, dyspnea and stridor may occur even at rest. These symptoms can be confused with other respiratory diseases (Rubikas R et al, 2014).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ibrahim r mohamed
  • Phone Number: 01005766816

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospitals
        • Contact:
          • Magdy M Amin, professor

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

Eligibility Criteria

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Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- patients who are diagnosed with layngotracheal stenosis either post tracheostomy or post intubation

Exclusion Criteria:

  • The exclusion criteria will be patients who underwent laryngeal split and cartilaginous grafting; patients who underwent carinal resection; patients with incomplete records; and resection due to conditions other than post intubation tracheal stenosis (e.g., airway tumors, idiopathic stenosis, trauma, Wegener' granulomatosis and chronic relapsing polychondritis).

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: resection anastomosis
resection of the stenotic part of the trachea and then doing re anastomosis
Procedure: resection anastomosis
resection of stenotic part of trachea and reanastmosis
Other Names:
  • long term stenting with Montgomery tube
Active Comparator: long term stenting with Montgomery tube
application of T shaped Montgomery tube for 6 months
Procedure: resection anastomosis
resection of stenotic part of trachea and reanastmosis
Other Names:
  • long term stenting with Montgomery tube

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
successful
Time Frame: 12 months
release of respiratory distress
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • soh-Med-24-06-01MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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