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

Sohag University

Status: Enrolling

Conditions: Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection

Treatments: Procedure: cervical collar or cervical-thoracic orthosis.; Device: chin-to-chest (Grillo) suturing

Study type: Interventional

Funder types: Other

Identifiers

NCT07059195

Soh-Med-25-6--2MD

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 6 months to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

• Group A (Non-invasive group)

Active Comparator group

Description:

Patients in this group will have postoperative cervical spine flexion maintained using non-invasive techniques, such as a cervical collar or cervical-thoracic orthosis.

Treatment:

Procedure: cervical collar or cervical-thoracic orthosis.

• Group B (Conventional group)

Active Comparator group

Description:

Patients in this group will have cervical spine flexion maintained using traditional chin-to-chest (Grillo) suturing

Treatment:

Device: chin-to-chest (Grillo) suturing