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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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• Group A (Non-invasive group)

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

Group Type ACTIVE_COMPARATOR

cervical collar or cervical-thoracic orthosis.

Intervention Type PROCEDURE

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

• Group B (Conventional group)

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

Group Type ACTIVE_COMPARATOR

chin-to-chest (Grillo) suturing

Intervention Type DEVICE

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

Interventions

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cervical collar or cervical-thoracic orthosis.

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

Intervention Type PROCEDURE

chin-to-chest (Grillo) suturing

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

Intervention Type DEVICE

Eligibility Criteria

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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