Clinical trial · Interventional
Role of Cervical Fascia Flap in Decreasing the Incidence of Pharyngocutaneous Fistula After Total Laryngectomy
NCT07241611CI-TRIAL-00097679completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor of the Larynx | Malignant Laryngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total laryngectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- cervical fascia flap group
- interventionNames
- Procedure: Total laryngectomy
- type
- ACTIVE_COMPARATOR
- label
- conventional repair group
- interventionNames
- Procedure: Total laryngectomy
Primary outcomes (1)
- measure
- incidence of pharyngocutaneous fistula after total laryngectomy
- timeFrame
- Four weeks
Secondary outcomes (2)
- measure
- subjective assessment of the swallowing function after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * All consecutive patients who will undergo total laryngectomy for advanced laryngeal carcinoma in the study duration. Exclusion Criteria: * Presence of extra-laryngeal extension. * Patients undergoing partial pharyngectomy. * Previous neck irradiation. * Previous neck surgery. * Patients' refusal to participate in the study.
References
Publications (4)
- BACKGROUNDZorlu 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. PMID 38940495
- BACKGROUNDWang 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. PMID 31712878
- BACKGROUNDEid 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. PMID 33009930
- BACKGROUNDPark 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. PMID 32836041