Rehabilitation Improved by Early Detection of Fisyulas Post (Pharyngo) -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 defined according to the level of inflammatory cytokines in drainage fluids on the second postoperative day. Secondary objectives To compare an early versus a late refeeding strategy for patients at low risk of fistula defined according to the level of inflammatory cytokines in drainage fluids on the second postoperative day for: * length of hospital stay, * evolution of nutritional status, * time to postoperative radio-chemotherapy, if indicated postoperatively, * improvement in quality of life, * post-operative complications other than pharyngeal fistula. Evaluation of different strategies left to the investigator\'s choice (continuation of antibiotic therapy, increased delay before resumption of feeding, early resumption of surgery) in the group of patients at high risk of fistula, based on the determination of postoperative cytokines in drainage fluids. Primary endpoint: Pharyngo-cutaneous fistula occurring within 30 days post-operatively (yes/no). Number of subjects: 250 Inclusion criteria Major cancer patient justifying scheduled total laryngectomy or pharyngo-laryngectomy after multidisciplinary consultation. Holder of a social security plan. Non-inclusion criteria Pregnant and breast-feeding women Persons under curatorship, guardianship, safeguard of justice or deprived of liberty. Any medical condition deemed incompatible with the study by the investigator. Refusal to participate. Body mass index less than 18.5 kg/m2

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patient with cancer requiring a total laryngectomy or pharyngolaryngectomy scheduled after multidisciplinary consultation.

• Holder of a social security scheme

Locations
Other Locations
France
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU de Grenoble
NOT_YET_RECRUITING
Grenoble
CH Emile Roux
NOT_YET_RECRUITING
Le Puy-en-velay
HCL Hôpital Croix Rousse
NOT_YET_RECRUITING
Lyon
CHU de Saint-Etienne
NOT_YET_RECRUITING
Saint-etienne
CH de Valence
NOT_YET_RECRUITING
Valence
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Contact Information
Primary
Lise Laclautre
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2028-05
Participants
Target number of participants: 250
Treatments
Experimental: Early group
For an IL 10 level on postoperative day 2 below 72 pg/mL (group said to be at low risk of developing a fistula defined from the DEFILAC pilot study), resumption of food on the 3rd or 4th postoperative day with a mixed diet.
Placebo_comparator: late group
For an IL 10 level on postoperative day 2 below 72 pg/mL (group said to be at low risk of developing a fistula defined from the DEFILAC pilot study), resumption of food on the 3rd or 4th postoperative day with a mixed diet.
No_intervention: No intervention
For an IL 10 level on postoperative day 2 greater than 72 pg/mL (group at high risk of postoperative fistula), these patients will constitute a third, exploratory group, whose management will be left to the investigator's discretion.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov