Condition: Cancer, Otorhinolaryngeal · Sponsor: University Hospital, Clermont-Ferrand
Post-pharyngo-laryngectomy fistula is a frequent surgical complication, resulting in delayed patient management and reduced quality of life. A recent study has shown that the appearance of a fistula can be detected early by measuring cytokines (particularly IL10) in postoperative drainage fluids. Resumption of feeding following this surgery varies between postoperative day 5 and postoperative day 15, depending on the team\'s habits. Early refeeding reduces the length of hospital stay and improves patients\' quality of life. The decision to refeed is currently made without any clinical or biological marker of the quality of pharyngeal suture healing. The idea of this study is that good initial healing (evidenced by low levels of inflammatory cytokine in drainage fluids) allows early refeeding without putting the patient at additional risk. Main hypothesis and research objectives Main hypothesis: the determination of cytokines in postoperative drainage fluids (FODP) could be a tool for screening patients at no risk of developing a fistula, and for whom early refeeding (as early as postoperative day 3) could be proposed without exposing the patient to an additional risk of developing a FODP. Study objectives Primary objective: to compare the rate of post-(pharyngo)-total laryngectomy fistula between an early refeeding strategy (3rd or 4th postoperative day) and a late refeeding strategy (current standard of care: 7th postoperative day) in a low-risk fistula group defin…
This description comes directly from the study's public registry record.
Lise Laclautre · 334.73.754.963 · promo_interne_drci@chu-clermontferrand.fr
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| CHU de Clermont-Ferrand | Clermont-Ferrand, France | Recruiting |
| CHU de Grenoble | Grenoble, France | Not Yet Recruiting |
| CH Emile Roux | Le Puy-en-Velay, France | Not Yet Recruiting |
| HCL Hôpital Croix Rousse | Lyon, France | Not Yet Recruiting |
| CHU de Saint-Etienne | Saint-Etienne, France | Not Yet Recruiting |
| CH de Valence | Valence, France | Not Yet Recruiting |
| Institut Gustave Roussy | Villejuif, France | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06604494