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

NCT ID: NCT06499987

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-01

Brief Summary

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).

Conditions

Grade 3 Benign Laryngotracheal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

resection anastomosis

resection of the stenotic part of the trachea and then doing re anastomosis

Group Type: ACTIVE_COMPARATOR

resection anastomosis

Intervention Type: PROCEDURE

resection of stenotic part of trachea and reanastmosis

long term stenting with Montgomery tube

application of T shaped Montgomery tube for 6 months

Group Type: ACTIVE_COMPARATOR

resection anastomosis

Intervention Type: PROCEDURE

resection of stenotic part of trachea and reanastmosis

Interventions

resection anastomosis

resection of stenotic part of trachea and reanastmosis

Intervention Type: PROCEDURE

Other Intervention Names

long term stenting with Montgomery tube

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Awatef Mahmoud Ahmed

assistant lecturer of otorhinolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University hospitals

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

awatef m ahmed, assisstant lecturer

Role: CONTACT

awatef.ahmed@med.edu.eg

01001126391

Ibrahim r mohamed

Role: CONTACT

01005766816

Facility Contacts

magdy m Amin, Professor

Role: primary

References

Weksler B. Commentary: The role of gastroesophageal reflux in patients with acquired tracheal stenosis. J Thorac Cardiovasc Surg. 2019 Dec;158(6):1708-1709. doi: 10.1016/j.jtcvs.2019.08.071. Epub 2019 Sep 19. No abstract available.

Reference Type: BACKGROUND

PMID: 31604634 (View on PubMed)

Belafsky PC, Postma GN, Koufman JA. The validity and reliability of the reflux finding score (RFS). Laryngoscope. 2001 Aug;111(8):1313-7. doi: 10.1097/00005537-200108000-00001.

Reference Type: BACKGROUND

PMID: 11568561 (View on PubMed)

Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.

Reference Type: BACKGROUND

PMID: 12150380 (View on PubMed)

Liu J, Zhang CP, Li Y, Dong S. Post-intubation tracheal stenosis after management of complicated aortic dissection: a case series. J Cardiothorac Surg. 2015 Nov 4;10:148. doi: 10.1186/s13019-015-0357-z.

Reference Type: BACKGROUND

PMID: 26537875 (View on PubMed)

Other Identifiers

soh-Med-24-06-01MD

Identifier Type: -

Identifier Source: org_study_id