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NCT Number: NCT07059195

Non-Invasive Techniques to Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection

Tracheal surgery represents a relatively recent advancement in the field of thoracic surgery. The trachea has unique anatomical and physiological challenges that historically rendered surgical manipulation both risky and limited. Early interventions involving the trachea were primarily restricted to emergency tracheostomy procedures, typically performed as life-saving measures during acute airway obstruction (1). Attempts at tracheal reconstruction were largely unsuccessful due to the absence of suitable anesthesia, inadequate surgical tools, and the prevailing belief that tracheal cartilage lacked sufficient regenerative. As a result, tracheal resection and reconstruction were long considered unfeasible (2).

The modern era of tracheal surgery began to take shape in the mid-20th century. While early attempts at tracheal resection were performed with limited success, it was the pioneering work of Dr. Hermes C. Grillo in the 1960s that truly transformed the field. Through systematic study of tracheal anatomy, vascular supply, and biomechanics, Dr. Grillo developed standardized and safe techniques for segmental tracheal resection followed by primary end-to-end anastomosis. His work demonstrated that segmental resection of the trachea followed by primary end-to-end anastomosis was feasible and safe (3)(4).

Recruiting

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Key information

Age range

6 month–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, Professor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All pediatric and adult patients undergoing tracheal and cricotracheal resection for benign air way stenosis
  • All pediatric and adult patients undergoing tracheal and cricotracheal resection for malignant pathologies

Exclusion criteria

  • patients with previous cervical spine surgery.
  • Congenital or acquired spinal deformities.

Treatment and study plan

cervical collar or cervical-thoracic orthosis.

Procedure

postoperative cervical spine flexion maintained using non-invasive techniques, such as a cervical collar or cervical-thoracic orthosis.

chin-to-chest (Grillo) suturing

Device

cervical spine flexion maintained using traditional chin-to-chest (Grillo) suturing

Primary outcomes

  1. cervical spine flexion

    Time frame: 2 years

    Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Talal Mahmoud, Assisstent lecturer

CONTACT

[email protected]

01001317023

Khaled Mohamed Abdelaal

CONTACT

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.