Malignant Tumor of the LarynxNCT06256263
Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy
A study testing total laryngectomy in people with Malignant Tumor of the Larynx, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Tumor of the Larynx
- What is being tested?
- total laryngectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 consecutive patients undergoing total laryngectomy for advanced laryngeal carcinoma in the study duration .
Who cannot join
- Infiltration of the safety margins proved by postoperative histopathology .
- Patients with tumor extension to the tongue base, or the hypopharynx .
- Patients who are unfit for surgery .
- Patients refusal to surgical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Linear Stapler Versus Conventional Repair of the Pharynx After Total Laryngectomy: Functional and Oncological Outcomes
This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.
- Conditions
- Malignant Tumor of the Larynx
- Being tested
- total laryngectomy
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total laryngectomyProcedure or surgery
pharyngeal repair after total laryngectomy
| Study group | Role | What they receive |
|---|---|---|
| stapler repair group | Active comparator | pharyngeal repair after total laryngectomy was done by using a linear stapler Receives: Procedure: total laryngectomy |
| conventional repair group | Active comparator | pharyngeal repair after total laryngectomy was done by the conventional method (stitching). Receives: Procedure: total laryngectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pharyngocutaneous fistula after total laryngectomy
to assess the effectiveness of pharyngeal repair and healing without pharyngocutaneous fistula
Measured: four weeks
Secondary outcomes (1)
assessment of the swallowing function after surgery
swallowing was evaluated subjectively by applying the Sydney Swallow Questionnaire, (SSQ) and was evaluated objectively by performing modified barium swallow and functional endoscopic evaluation of swallowing (FEES)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Tumor of the LarynxStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256263
- Sponsor's protocol ID
- MD.21.06.491
- Status last verified
- Feb 2024
- First submitted
- 3 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sansa-Perna A, Casasayas-Plass M, Rovira-Martinez C, Lopez-Vilas M, Garcia-Lorenzo J, Quer-Agusti M, Leon-Vintro X. Pharyngeal closure after a total laryngectomy: mechanical versus manual technique. J Laryngol Otol. 2020 Jul;134(7):626-631. doi: 10.1017/S0022215120001371. Epub 2020 Jul 29.
PubMed 32723416Sannikorn P, Pornniwes N. Comparison of outcomes for staple and conventional closure of the pharynx following total laryngectomy. J Med Assoc Thai. 2013 Mar;96 Suppl 3:S89-93.
PubMed 23682529Shan H, Gao Y, Liu L, Li M, Gao X, Li Y, Wang X, Ouyang D, Guo Z. Magnifying endoscopy with narrow-band imaging to assist the linear stapler closure of the pharynx during total laryngectomy. Am J Otolaryngol. 2018 Sep-Oct;39(5):511-514. doi: 10.1016/j.amjoto.2018.05.014. Epub 2018 May 28.
PubMed 29903625
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linear Stapler Versus Conventional Repair of the Pharynx After Total Laryngectomy: Functional and Oncological Outcomes
- ClinicalTrials.gov ID
- NCT06256263
- Acronym / sponsor ID
- MD.21.06.491
- Conditions
- Malignant Tumor of the Larynx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Feb 2024 (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.
This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stapler repair group | Active comparator | Procedure: total laryngectomypharyngeal repair after total laryngectomy was done by using a linear stapler |
| conventional repair group | Active comparator | Procedure: total laryngectomypharyngeal repair after total laryngectomy was done by the conventional method (stitching). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients undergoing total laryngectomy for advanced laryngeal carcinoma in the study duration .
Key exclusion criteria (4 listed)
- Infiltration of the safety margins proved by postoperative histopathology .
- Patients with tumor extension to the tongue base, or the hypopharynx .
- Patients who are unfit for surgery .
- Patients refusal to surgical treatment
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 |
|---|---|---|
| total laryngectomypharyngeal repair after total laryngectomy | Procedure or surgery | conventional repair group, stapler repair group |
Primary outcome
incidence of pharyngocutaneous fistula after total laryngectomy
Time frame: four weeks
to assess the effectiveness of pharyngeal repair and healing without pharyngocutaneous fistula
1 secondary outcome
assessment of the swallowing function after surgery
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 32723416Sansa-Perna A, Casasayas-Plass M, Rovira-Martinez C, Lopez-Vilas M, Garcia-Lorenzo J, Quer-Agusti M, Leon-Vintro X. Pharyngeal closure after a total laryngectomy: mechanical versus manual technique. J Laryngol Otol. 2020 Jul;134(7):626-631. doi: 10.1017/S0022215120001371. Epub 2020 Jul 29.
- Background: PubMed 23682529Sannikorn P, Pornniwes N. Comparison of outcomes for staple and conventional closure of the pharynx following total laryngectomy. J Med Assoc Thai. 2013 Mar;96 Suppl 3:S89-93.
- Background: PubMed 29903625Shan H, Gao Y, Liu L, Li M, Gao X, Li Y, Wang X, Ouyang D, Guo Z. Magnifying endoscopy with narrow-band imaging to assist the linear stapler closure of the pharynx during total laryngectomy. Am J Otolaryngol. 2018 Sep-Oct;39(5):511-514. doi: 10.1016/j.amjoto.2018.05.014. Epub 2018 May 28.
- Individual participant dataSharing planned: No
Related trials for Malignant Tumor of the Larynx
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingEarly Phase 1
PET/CT Assessment of Radiation-Induced Vascular Complications in Head and Neck Cancer
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Not yet recruitingPhase 1/2
Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and Neck Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total laryngectomy in people with Malignant Tumor of the Larynx, run by Mansoura 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 1 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: finished, as of the sponsor's last update on 13 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of pharyngocutaneous fistula after total laryngectomy (time frame: four weeks). 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 NCT06256263, which also lists 3 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 13 Feb 2024.