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

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

Conditions

• Cancer, Otorhinolaryngeal

Interventions

BEHAVIORAL

early feeding resumption

Resumption of food on the 3rd or 4th day post-operatively with a mixed diet.

BEHAVIORAL

late feeding resumption

Resumption of food on the 7th day post-operatively with a mixed diet.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Nicolas Saroul · University Hospital, Clermont-Ferrand

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-12

Primary Completion

2028-05-31

Completion

2028-05-31

Countries

• France

Study Locations