Tracheal StenosisNCT06917222
Slide Tracheoplasty Versus Tracheal Resection Anastomosis in Acquired Tracheal Stenosis
A study testing Slide tracheoplasty and Tracheal resection anastomosis in people with Tracheal Stenosis and Subglottic Stenosis, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Aim of the Work To compare the clinical outcomes between patients will undergo slide tracheoplasty and those will undergo tracheal resection anastomosis for acquired tracheal stenosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tracheal Stenosis, Subglottic Stenosis
- What is being tested?
- Slide tracheoplasty and Tracheal resection anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Aug 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with grade III, IV acquired tracheal stenosis (e.g., due to trauma, prolonged intubation) regardless their age or sex.
- Patient with symptomatic high grade II acquired laryngotracheal stenosis after failure of endoscopic interventions.
- Clinical indications for surgical intervention (Symptoms of airway obstruction).
- Feasible for surgical intervention.
Who cannot join
- congenital tracheal stenosis
- Malignant stenosis.
- Severe comorbidities that contraindicate the surgery.
- Patients refusing to sign the consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Eslam Hamed
Al Mansurah
Abdou, +201015566532, dreslamhamed1@gmail.com
About this study
Aim of the Work To compare the clinical outcomes between patients will undergo slide tracheoplasty and those will undergo tracheal resection anastomosis for acquired tracheal stenosis.
- Conditions
- Tracheal Stenosis, Subglottic Stenosis
- Being tested
- Slide tracheoplasty, Tracheal resection anastomosis
- Keywords
- Slide tracheoplasty, Tracheal resection anastomosis
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slide tracheoplastyProcedure or surgery
Management of tracheal stenosis by slide tracheoplasty
Tracheal resection anastomosisProcedure or surgery
Management of tracheal stenosis by tracheal resection anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Slide tracheoplasty | Experimental | Not described Receives: Procedure: Slide tracheoplasty |
| Tracheal resection anastomosis | Experimental | Not described Receives: Procedure: Tracheal resection anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Procedure
Defined as the absence of stridor or the need for re-intervention within a defined follow-up period (3 months
Measured: 3-6 months
Secondary outcomes (3)
Complication Rates
Evaluation of perioperative complications:
- Immediate Complications: Airway obstruction, pneumothorax, anastomotic leak, or accidental injury to surrounding structures (e.g., RLN).
- Delayed Complications: Stenosis, granulation tissue formation, tracheomalacia, or infection (e.g., mediastinitis).
- Mortality Rate: Intraoperative and 30-day mortality rates
Measured: 3 months
Duration of Hospital Stay
Measured from the day of surgery to discharge
Measured: 3 months
Time to Decannulation
Time taken for patients to be successfully decannulated, which can be indicative of recovery and airway stability.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 May 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Hamed Elsayed Abdou, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917222
- Sponsor's protocol ID
- Slide tracheoplasty
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Manning PB, Rutter MJ, Lisec A, Gupta R, Marino BS. One slide fits all: the versatility of slide tracheoplasty with cardiopulmonary bypass support for airway reconstruction in children. J Thorac Cardiovasc Surg. 2011 Jan;141(1):155-61. doi: 10.1016/j.jtcvs.2010.08.060. Epub 2010 Nov 5.
PubMed 21055774Schweiger C, Cohen AP, Rutter MJ. Tracheal and bronchial stenoses and other obstructive conditions. J Thorac Dis. 2016 Nov;8(11):3369-3378. doi: 10.21037/jtd.2016.11.74.
PubMed 28066618Smith MM, Cotton RT. Diagnosis and management of laryngotracheal stenosis. Expert Rev Respir Med. 2018 Aug;12(8):709-717. doi: 10.1080/17476348.2018.1495564. Epub 2018 Jul 12.
PubMed 29969925Tsang V, Murday A, Gillbe C, Goldstraw P. Slide tracheoplasty for congenital funnel-shaped tracheal stenosis. Ann Thorac Surg. 1989 Nov;48(5):632-5. doi: 10.1016/0003-4975(89)90777-7.
PubMed 2818051Zalzal HG, Behzadpour HK, Leonard J, Sinha P, Preciado DA. Systematic Review of Slide Tracheoplasty Outcomes. Ann Otol Rhinol Laryngol. 2023 May;132(5):558-565. doi: 10.1177/00034894221104955. Epub 2022 Jun 20.
PubMed 35723210Bocage JP, Caccavale R, Lewis R, Sisler G, MacKenzie J. Tracheal stenosis. N J Med. 1990 Aug;87(8):631-4.
PubMed 2395535de Alarcon A, Rutter MJ. Cervical slide tracheoplasty. Arch Otolaryngol Head Neck Surg. 2012 Sep;138(9):812-6. doi: 10.1001/archoto.2012.1768.
PubMed 22986713Freitag L, Darwiche K. Endoscopic treatment of tracheal stenosis. Thorac Surg Clin. 2014 Feb;24(1):27-40. doi: 10.1016/j.thorsurg.2013.10.003.
PubMed 24295657Grillo HC. Surgical treatment of postintubation tracheal injuries. J Thorac Cardiovasc Surg. 1979 Dec;78(6):860-75.
PubMed 502569Li C, Rutter MJ. Acquired tracheal stenosis: Cervical slide tracheoplasty. Semin Pediatr Surg. 2021 Jun;30(3):151058. doi: 10.1016/j.sempedsurg.2021.151058. Epub 2021 May 25.
PubMed 34172213Abdou EH, Elkahwagi M, Elsobki AA, Elshaer M. Slide tracheoplasty versus tracheal resection anastomosis for acquired laryngotracheal stenosis: a prospective randomized controlled trial. Eur Arch Otorhinolaryngol. 2026 Jul;283(7):4515-4525. doi: 10.1007/s00405-026-10296-8. Epub 2026 May 21.
PubMed 42165884
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slide Tracheoplasty Versus Tracheal Resection Anastomosis in Acquired Tracheal Stenosis
- ClinicalTrials.gov ID
- NCT06917222
- Acronym / sponsor ID
- Slide tracheoplasty
- Conditions
- Tracheal Stenosis, Subglottic Stenosis
- Keywords
- Slide tracheoplasty, Tracheal resection anastomosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 8 Apr 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.
Aim of the Work To compare the clinical outcomes between patients will undergo slide tracheoplasty and those will undergo tracheal resection anastomosis for acquired tracheal stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slide tracheoplasty | Experimental | Procedure: Slide tracheoplasty |
| Tracheal resection anastomosis | Experimental | Procedure: Tracheal resection anastomosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with grade III, IV acquired tracheal stenosis (e.g., due to trauma, prolonged intubation) regardless their age or sex.
Key exclusion criteria (4 listed)
- congenital tracheal stenosis
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 |
|---|---|---|
| Slide tracheoplastyManagement of tracheal stenosis by slide tracheoplasty | Procedure or surgery | Slide tracheoplasty |
| Tracheal resection anastomosisManagement of tracheal stenosis by tracheal resection anastomosis | Procedure or surgery | Tracheal resection anastomosis |
Primary outcome
Success Rate of Procedure
Time frame: 3-6 months
Defined as the absence of stridor or the need for re-intervention within a defined follow-up period (3 months
3 secondary outcomes
Complication Rates
Time frame: 3 months
Duration of Hospital Stay
Time frame: 3 months
Time to Decannulation
Time frame: 3 months
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 25 Sep 2025.
- Background: PubMed 21055774Manning PB, Rutter MJ, Lisec A, Gupta R, Marino BS. One slide fits all: the versatility of slide tracheoplasty with cardiopulmonary bypass support for airway reconstruction in children. J Thorac Cardiovasc Surg. 2011 Jan;141(1):155-61. doi: 10.1016/j.jtcvs.2010.08.060. Epub 2010 Nov 5.
- Background: PubMed 28066618Schweiger C, Cohen AP, Rutter MJ. Tracheal and bronchial stenoses and other obstructive conditions. J Thorac Dis. 2016 Nov;8(11):3369-3378. doi: 10.21037/jtd.2016.11.74.
- Background: PubMed 29969925Smith MM, Cotton RT. Diagnosis and management of laryngotracheal stenosis. Expert Rev Respir Med. 2018 Aug;12(8):709-717. doi: 10.1080/17476348.2018.1495564. Epub 2018 Jul 12.
- Background: PubMed 2818051Tsang V, Murday A, Gillbe C, Goldstraw P. Slide tracheoplasty for congenital funnel-shaped tracheal stenosis. Ann Thorac Surg. 1989 Nov;48(5):632-5. doi: 10.1016/0003-4975(89)90777-7.
- Background: PubMed 35723210Zalzal HG, Behzadpour HK, Leonard J, Sinha P, Preciado DA. Systematic Review of Slide Tracheoplasty Outcomes. Ann Otol Rhinol Laryngol. 2023 May;132(5):558-565. doi: 10.1177/00034894221104955. Epub 2022 Jun 20.
- Results publication: PubMed 2395535Bocage JP, Caccavale R, Lewis R, Sisler G, MacKenzie J. Tracheal stenosis. N J Med. 1990 Aug;87(8):631-4.
- Results publication: PubMed 22986713de Alarcon A, Rutter MJ. Cervical slide tracheoplasty. Arch Otolaryngol Head Neck Surg. 2012 Sep;138(9):812-6. doi: 10.1001/archoto.2012.1768.
- Results publication: PubMed 24295657Freitag L, Darwiche K. Endoscopic treatment of tracheal stenosis. Thorac Surg Clin. 2014 Feb;24(1):27-40. doi: 10.1016/j.thorsurg.2013.10.003.
- Results publication: PubMed 502569Grillo HC. Surgical treatment of postintubation tracheal injuries. J Thorac Cardiovasc Surg. 1979 Dec;78(6):860-75.
- Results publication: PubMed 34172213Li C, Rutter MJ. Acquired tracheal stenosis: Cervical slide tracheoplasty. Semin Pediatr Surg. 2021 Jun;30(3):151058. doi: 10.1016/j.sempedsurg.2021.151058. Epub 2021 May 25.
- Derived from this study: PubMed 42165884Abdou EH, Elkahwagi M, Elsobki AA, Elshaer M. Slide tracheoplasty versus tracheal resection anastomosis for acquired laryngotracheal stenosis: a prospective randomized controlled trial. Eur Arch Otorhinolaryngol. 2026 Jul;283(7):4515-4525. doi: 10.1007/s00405-026-10296-8. Epub 2026 May 21.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slide tracheoplasty and Tracheal resection anastomosis in people with Tracheal Stenosis and Subglottic Stenosis, run by Mansoura University Hospital 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 4 inclusion and 4 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 25 Sep 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 Eslam Hamed Abdou, Assistant lecturer (+201015566532, eslamhamed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of Procedure (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917222, which also lists 11 linked publications.
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 25 Sep 2025.