Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal ResectionNCT07059195
Non-Invasive Techniques to Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection
A study testing cervical collar or cervical-thoracic orthosis. and chin-to-chest (Grillo) suturing in people with Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 80 years
- Conditions the study is for
- Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection
- What is being tested?
- cervical collar or cervical-thoracic orthosis. and chin-to-chest (Grillo) suturing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with previous cervical spine surgery.
- Congenital or acquired spinal deformities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Khaled Mohamed Abdelaal contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospital
Sohag
Magdy M Amin, Professor
About this study
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).
- Being tested
- cervical collar or cervical-thoracic orthosis., chin-to-chest (Grillo) suturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical collar or cervical-thoracic orthosis.Procedure or surgery
postoperative cervical spine flexion maintained using non-invasive techniques, such as a cervical collar or cervical-thoracic orthosis.
chin-to-chest (Grillo) suturingDevice
cervical spine flexion maintained using traditional chin-to-chest (Grillo) suturing
| Study group | Role | What they receive |
|---|---|---|
| • Group A (Non-invasive group) | Active comparator | Patients in this group will have postoperative cervical spine flexion maintained using non-invasive techniques, such as a cervical collar or cervical-thoracic orthosis. Receives: Procedure: cervical collar or cervical-thoracic orthosis. |
| • Group B (Conventional group) | Active comparator | Patients in this group will have cervical spine flexion maintained using traditional chin-to-chest (Grillo) suturing Receives: Device: chin-to-chest (Grillo) suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical spine flexion
Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start30 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal ResectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Talal Mahomud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059195
- Sponsor's protocol ID
- Soh-Med-25-6--2MD
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Techniques to Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection
- ClinicalTrials.gov ID
- NCT07059195
- Acronym / sponsor ID
- Soh-Med-25-6--2MD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Group A (Non-invasive group) | Active comparator | Procedure: cervical collar or cervical-thoracic orthosis.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 B (Conventional group) | Active comparator | Device: chin-to-chest (Grillo) suturingPatients in this group will have cervical spine flexion maintained using traditional chin-to-chest (Grillo) suturing |
Who may qualify
- Ages
- 6 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- patients with previous cervical spine surgery.
- Congenital or acquired spinal deformities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical collar or cervical-thoracic orthosis.postoperative cervical spine flexion maintained using non-invasive techniques, such as a cervical collar or cervical-thoracic orthosis. | Procedure or surgery | • Group A (Non-invasive group) |
| chin-to-chest (Grillo) suturingcervical spine flexion maintained using traditional chin-to-chest (Grillo) suturing | Device | • Group B (Conventional group) |
Primary outcome
cervical spine flexion
Time frame: 2 years
Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khaled Mohamed Abdelaal contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical collar or cervical-thoracic orthosis. and chin-to-chest (Grillo) suturing in people with Maintain Neck Flexion and Reduce Anastomotic Tension After Tracheal Resection, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Talal Mahmoud, Assisstent lecturer (01001317023, abdelrahman_ahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cervical spine flexion (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.