Clinical trial · Interventional
Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy
Department of Otolaryngology Head Neck Surg
- 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)
Recruited patients are divided into two arms depending on laryngeal carcinoma's T1 and T2 stages. Two interventions were undergone, including transoral endoscopic laser cordectomy and open partial horizontal laryngectomy (OPHL). During the pre-and post-operative time, patients performed measurements of swallowing function, including direct subglottic pressure, Eating Assessment Tool-10(EAT-10) questionnaire, swallowing ability to different textures, and fiberoptic evaluation of swallowing(FEES). Patients undergo subglottic pressure measurement and swallowing function evaluation three times: 3-7 days, two months, and six months after surgery. Patients also performed measurement voice acoustic analysis and subjective assessment one-day pre-operation and six months post-operation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open partial horizontal laryngectomy(OPHL), Type I-III | Procedure | — | UNRESOLVED |
| Transoral endoscopic laser cordectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Supraglottic and glottic T2 laryngeal carcinoma
- description
- The open partial horizontal laryngectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T2
- interventionNames
- Procedure: Open partial horizontal laryngectomy(OPHL), Type I-III
- type
- ACTIVE_COMPARATOR
- label
- Supraglottic and glottic T1 laryngeal carcinoma
- description
- The transoral endoscopic laser cordectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T1
- interventionNames
- Procedure: Transoral endoscopic laser cordectomy
Primary outcomes (4)
- measure
- Fiberoptic laryngoscope evaluation of swallowing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-80 years * Surgical treatment by open partial horizontal laryngectomy type I or II and transoral laser cordectomy for squamous cell carcinoma * Availability of clinical data * Validity of normal swallowing of thin liquids Exclusion Criteria: * Presence of severe chronic obstructive pulmonary disease, severe heart disease, and psychopathy or mental disease * Surgery complications(such as sepsis, pharyngocutaneous fistula, surgical revision) * Radiotherapy histology * Swallowing disorder or trachea aspiration before surgery.
References
Publications (7)
- BACKGROUNDBagwell K, Leder SB, Sasaki CT. Is partial laryngectomy safe forever? Am J Otolaryngol. 2015 May-Jun;36(3):437-41. doi: 10.1016/j.amjoto.2014.11.005. Epub 2014 Nov 20. PMID 25595047
- BACKGROUNDFreitas AS, Santos IC, Furia C, Dornelas R, Silva ACAE, Dias FL, Salles GF. Prevalence and associated factors of aspiration and severe dysphagia in asymptomatic patients in the late period after open partial laryngectomy: a videofluoroscopic evaluation. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3695-3703. doi: 10.1007/s00405-021-07231-4. Epub 2022 Jan 4. PMID 34982204
- BACKGROUNDBreunig C, Benter P, Seidl RO, Coordes A. Predictable swallowing function after open horizontal supraglottic partial laryngectomy. Auris Nasus Larynx. 2016 Dec;43(6):658-65. doi: 10.1016/j.anl.2016.01.003. Epub 2016 Feb 4. PMID 26853312
- BACKGROUNDDawson C, Pracy P, Patterson J, Paleri V. Rehabilitation following open partial laryngeal surgery: key issues and recommendations from the UK evidence based meeting on laryngeal cancer. J Laryngol Otol. 2019 Mar;133(3):177-182. doi: 10.1017/S0022215119000483. PMID 30983563
- BACKGROUNDClarett M, Andreu MF, Salvati IG, Donnianni MC, Montes GS, Rodriguez MG. [Effect of subglottic air insufflation on subglottic pressure during swallowing]. Med Intensiva. 2014 Apr;38(3):133-9. doi: 10.1016/j.medin.2013.01.003. Epub 2013 Mar 6. Spanish. PMID 23473519
- BACKGROUNDAlaskarov E, Ozturk O, Batioglu-Karaaltin A, Gulmez ZD, Erdur ZB, Inan HC. Functional Outcomes of the Hyaluronic Acid Injections in Patients Who Underwent Partial Laryngectomy. J Voice. 2022 May;36(3):417-422. doi: 10.1016/j.jvoice.2020.06.026. Epub 2020 Jul 22. PMID 32712078
- BACKGROUNDFakhry N, Michel J, Giorgi R, Robert D, Lagier A, Santini L, Moreddu E, Puymerail L, Adalian P, Dessi P, Giovanni A. Analysis of swallowing after partial frontolateral laryngectomy with epiglottic reconstruction for glottic cancer. Eur Arch Otorhinolaryngol. 2014 Jul;271(7):2013-20. doi: 10.1007/s00405-013-2750-3. Epub 2013 Oct 8.