Study Title: Oncological and Functional Results After Total Laryngectomy and Pharyngolaryngectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The association between the use of a surgical flap and the incidence of post-operative fistulas during follow-up
研究概览
简要总结
Salvage total laryngectomy (TL) and total pharyngolaryngectomy (TPL) are the gold standard for most recurrent laryngeal and hypopharyngeal tumors as well as in patients with contraindication for chemoradiotherapy (CRT). Free or pedicled flaps are the two mandatory options for pharyngeal reconstruction after TPL, while remain an optional indication to protect the neopharynx after TL. The most common complication after TL or TPL is pharyngocutaneous fistula (PCF), with an incidence ranging from 3% to 65%, according to the surgical defect and type of reconstruction. The etiology of PCF is multifactorial and the most important risk factors are a history of CRT, low hemoglobin levels (< 12.5 g/dl), and malnutrition. A growing concern is the role of nutritional status, with sarcopenia as an emergent risk factor for post-operative complications, because muscle wasting negatively influences wound healing and overall recovery. Salivary stent placement, 3-layers neopharyngeal sutures, cricopharyngeal myotomy and prophylactic use of vascularized flaps are possible protective factors to reduce the risk of PCF. Despite these evidences, it remains unclear which are the best candidates for flap reconstruction, as well as which preoperative risk factors influence the risk of PCF.
The rationale of this ambispective monocentric study is to identify the risk factors statistically significant associated with the development of PCF and the influence of preoperative sarcopenia on postoperative complications risks following TL and TPL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients undergoing to TL with direct closure of the pharynx or TPL and reconstruction of the pharynx with a free or pedicled flap in cases of:
- •Naive laryngeal neoplasia (cT1-cT4a with possible extension to the esophagus, oropharynx, or hypopharynx);
- •Recurrence of laryngeal or hypopharyngeal cancer in patients previously treated with surgical intervention (TLM/CO2 laser or OPHL);
- •Recurrence of laryngeal or hypopharyngeal cancer in patients previously treated with RT or CRT;
- •Loss of laryngeal function induced by RT, CRT, or OPHL treatment;
- •Availability of data according to the assessments that must be made, including a follow-up period of at least 2 months.
排除标准
- •Lack of useful data to carry out the assessments related to the study itself
结局指标
主要结局
The association between the use of a surgical flap and the incidence of post-operative fistulas during follow-up
时间窗: within 30 days from surgery
Proportion of subjects who develop a post-operative fistula (blind or pharyngo-cutaneous fistula, PCF, with or without the use of a surgical flap, which develop within 30 days from surgery
次要结局
- The incidence of any post-operative complications(1-36 months follow-up)
- The prognostic role of both the use of a surgical flap and the development of post-operative fistulas(36 months after surgery)
- The association between the use of a surgical flap and the incidence of mid to longterm post-operative fistulas(30 days and at mid to long term.)
- Potential correlates of fistulas development both within 30 days and at mid to long term(30 days and 36 months)
- 36 months incidence of tumor related events(36 months after surgery)
研究者
Marco Benazzo
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia