CClinicalTrials.gg
RecruitingNCT07059195Updated Jul 10, 2025

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

An interventional study of cervical collar or cervical-thoracic orthosis. and chin-to-chest (Grillo) suturing in Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 6 Months to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-10.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
6 Months to 80 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    • 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.

    Procedure: cervical collar or cervical-thoracic orthosis.

  • Active comparator
    • Group B (Conventional group)

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

    Device: chin-to-chest (Grillo) suturing

Interventions

  • Procedurecervical collar or cervical-thoracic orthosis.

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

  • Devicechin-to-chest (Grillo) suturing

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

06

What researchers measure

Primary outcomes

  1. cervical spine flexion

    Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Sohag University hospital
    Sohag, Egypt
    • Magdy M Amin, Professor · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07059195
Lead sponsor
Sohag University
Responsible party
Abdelrahman Talal Mahomud (Assisstent lecturer at cardiothorathic department, Sohag University) — Principal investigator
First posted
Jul 10, 2025
Start date
Jun 30, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 10, 2025

Study contacts

Abdelrahman Talal Mahmoud, Assisstent lecturer
Contact
abdelrahman_ahmed@med.sohag.edu.eg
01001317023
Khaled Mohamed Abdelaal
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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