Rehabilitation Improved by Early Detection of Fisyulas Post (Pharyngo) -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 12
- 主要终点
- Pharyngocutaneous fistula occurring within 30 days postoperatively
研究概览
简要总结
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
详细描述
Course of the study Patients will be recruited from the ENT departments of the Clermont Ferrand, Saint-Etienne, Lyon and Grenoble university hospitals, the Lyon (Centre Léon Bérard) and Paris (Institut Gustave Roussy) cancer centers, and the Le Puy En Velay and Valence hospitals, all of which are accredited for cervico-facial carcinology.
A multidisciplinary consultation meeting will be required to validate the surgical procedure.
Patients will be informed of the study by the investigating physician. After a period of reflection and a chance to answer any questions, the patient will be included in the study after consent has been obtained from an investigator.
The main risk factors for the development of a fistula will be recorded pre- and intraoperatively.
Surgical criteria will be common to all investigating teams. The most important of these will be the positioning of the LDPO collection drain opposite the pharyngeal closure site. The drain may or may not be aspirative, depending on local habits. The concomitant insertion of a phonatory prosthesis or a salivary bypass are not grounds for exclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient with cancer requiring a total laryngectomy or pharyngolaryngectomy scheduled after multidisciplinary consultation.
- •Holder of a social security scheme
排除标准
- •Pregnant and breastfeeding women Persons under curatorship, guardianship, legal protection or deprived of liberty Any medical condition deemed by the investigator to be incompatible with the study. Refusal to participate. Body mass index less than 18.5 kg/ m2
结局指标
主要结局
Pharyngocutaneous fistula occurring within 30 days postoperatively
时间窗: Day 30
Apparition or not of Pharyngocutaneous fistula occurring within 30 days postoperatively (yes/no).
次要结局
- Tumor status(Day 30)
- Hospitalization time in days.(Day 30)
- Evolution of Weight in kg(Day 30)
- Nutrition Risk INdex(Day 30)
- Measure of grip strenght(Day 30)
- Deadlines for the implementation of post-operative radio-chemotherapy(Day 30)
- Clavien-Dindo Classification(Day 30)
- Beck Depression Inventory II questionnaire(Day 30)
- Beck Anxiety Inventory(Day 30)
- EORTC-QLQ30 questionnaire(Day 30)
- Cytobacteriological examination of the drainage fluid.(Day 2)
- continuation of antibiotic therapy(Day 30)
- Resuming food(Day 30)
- Surgical resumption(Day 30)