Malignant Tumor of the LarynxNCT07241611
Role of Cervical Fascia Flap in Decreasing the Incidence of Pharyngocutaneous Fistula After Total Laryngectomy
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 conducted to evaluate the potential role of using the cervical fascia flap over the pharyngeal closure line to enhance healing and subsequently to decrease the incidence of pharyngocutaneous fistula 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
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 30 Sep 2025
- 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 who will undergo total laryngectomy for advanced laryngeal carcinoma in the study duration.
Who cannot join
- Presence of extra-laryngeal extension.
- Patients undergoing partial pharyngectomy.
- Previous neck irradiation.
- Previous neck surgery.
- Patients' refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
This study was conducted to evaluate the potential role of using the cervical fascia flap over the pharyngeal closure line to enhance healing and subsequently to decrease the incidence of pharyngocutaneous fistula 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 larygectomy
| Study group | Role | What they receive |
|---|---|---|
| cervical fascia flap group | Active comparator | Not described Receives: Procedure: Total laryngectomy |
| conventional repair group | Active comparator | Not described 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
Measured: Four weeks
Secondary outcomes (2)
subjective assessment of the swallowing function after surgery
swallowing was evaluated subjectively by applying the Eating Assessment Tool (EAT-10) questionnaire
Measured: three months
objective assessment of the swallowing function after surgery
swallowing was evaluated objectively by functional endoscopic evaluation of swallowing (FEES)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Jul 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 50 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
- NCT07241611
- Sponsor's protocol ID
- MS.24.08.2855
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zorlu ME, Kertmen C, Aysel A, Yilmaz F, Dalgic A, Muderris T. Use of Cervical Fascia to Prevent Pharyngocutaneus Fistula After Total Laryngectomy. Laryngoscope. 2024 Dec;134(12):4964-4970. doi: 10.1002/lary.31606. Epub 2024 Jun 28.
PubMed 38940495Wang M, Xun Y, Wang K, Lu L, Yu A, Guan B, Yu C. Risk factors of pharyngocutaneous fistula after total laryngectomy: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2020 Feb;277(2):585-599. doi: 10.1007/s00405-019-05718-9. Epub 2019 Nov 11.
PubMed 31712878Eid AM, Ebada HA, El-Fattah AMA, Tawfik A. Platelet-rich fibrin: an autologous biomaterial for healing assistance of pharyngeal repair in total laryngectomy. Eur Arch Otorhinolaryngol. 2021 Feb;278(2):463-470. doi: 10.1007/s00405-020-06404-x. Epub 2020 Oct 3.
PubMed 33009930Park J, Chang C, Kwon D. Use of fibrin adhesive for preventing pharyngocutaneous fistula in total laryngectomy. Am J Otolaryngol. 2020 Nov-Dec;41(6):102674. doi: 10.1016/j.amjoto.2020.102674. Epub 2020 Aug 13.
PubMed 32836041
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cervical Fascia Flap in Decreasing the Incidence of Pharyngocutaneous Fistula After Total Laryngectomy
- ClinicalTrials.gov ID
- NCT07241611
- Acronym / sponsor ID
- MS.24.08.2855
- Conditions
- Malignant Tumor of the Larynx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 21 Nov 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.
This study was conducted to evaluate the potential role of using the cervical fascia flap over the pharyngeal closure line to enhance healing and subsequently to decrease the incidence of pharyngocutaneous fistula 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 |
|---|---|---|
| cervical fascia flap group | Active comparator | Procedure: Total laryngectomy |
| conventional repair group | Active comparator | Procedure: Total laryngectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients who will undergo total laryngectomy for advanced laryngeal carcinoma in the study duration.
Key exclusion criteria (5 listed)
- Presence of extra-laryngeal extension.
- Patients undergoing partial pharyngectomy.
- Previous neck irradiation.
- Previous neck surgery.
- Patients' refusal to participate in the study.
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 larygectomy | Procedure or surgery | cervical fascia flap group, conventional repair group |
Primary outcome
incidence of pharyngocutaneous fistula after total laryngectomy
Time frame: Four weeks
2 secondary outcomes
subjective assessment of the swallowing function after surgery
Time frame: three months
objective assessment of the swallowing function after surgery
Time frame: Three 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 21 Nov 2025.
- Background: PubMed 38940495Zorlu ME, Kertmen C, Aysel A, Yilmaz F, Dalgic A, Muderris T. Use of Cervical Fascia to Prevent Pharyngocutaneus Fistula After Total Laryngectomy. Laryngoscope. 2024 Dec;134(12):4964-4970. doi: 10.1002/lary.31606. Epub 2024 Jun 28.
- Background: PubMed 31712878Wang M, Xun Y, Wang K, Lu L, Yu A, Guan B, Yu C. Risk factors of pharyngocutaneous fistula after total laryngectomy: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2020 Feb;277(2):585-599. doi: 10.1007/s00405-019-05718-9. Epub 2019 Nov 11.
- Background: PubMed 33009930Eid AM, Ebada HA, El-Fattah AMA, Tawfik A. Platelet-rich fibrin: an autologous biomaterial for healing assistance of pharyngeal repair in total laryngectomy. Eur Arch Otorhinolaryngol. 2021 Feb;278(2):463-470. doi: 10.1007/s00405-020-06404-x. Epub 2020 Oct 3.
- Background: PubMed 32836041Park J, Chang C, Kwon D. Use of fibrin adhesive for preventing pharyngocutaneous fistula in total laryngectomy. Am J Otolaryngol. 2020 Nov-Dec;41(6):102674. doi: 10.1016/j.amjoto.2020.102674. Epub 2020 Aug 13.
- Individual participant dataSharing planned: No
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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. 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 5 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 21 Nov 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?
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 NCT07241611, which also lists 4 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 21 Nov 2025.