Evaluation of a Multimodal Program of Prehabilitation in Patients Undergoing Esophagectomy Within an ERAS Pathway
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Post-operative complications
研究概览
简要总结
Despite important clinical improvements, esophageal cancer surgery is still associated to a high rate of postoperative complications. Recent ERAS (Enhanced Recovery After Surgery) Society guidelines underline the possible role of prehabilitations' programs in reducing postoperative morbidity. In this trial, 200 patients, scheduled for esophageal cancer resection, will be randomly assigned to two groups (100 patients for each group). In both groups, patients will perform a basal evaluation with a physiotherapist, a nutritionist and a psychologist. In the treatment group, each patient will receive a tailored prehabilitative program and, during the 4 weeks before surgery, will be monitored constantly by each single specialist. A preoperative revaluation (the day before surgery) and follow up visits at 3 and 6 months will be performed for all patients. The incidence of postoperative complications, the length of hospital stay, and the reach of discharge criteria will be registered.
详细描述
Multi-modal prehabilitation programs reported positive results in patients undergoing colonic resection. These protocols are, generally, based on physiotherapist, nutritional and psychological implementation programs. Nevertheless, the conflicting results obtained in previous trials demonstrate how many elements have still to be clarified and that, probably, the pre-habilitation interventions must be tailored, as much as possible, on the peculiar characteristics of each single patient, modifying the approach as a function of the clinical specific response. All these considerations suggest a strong basis for tailored interventions in patients undergoing esophageal surgery, highlighting at the same time, as concluded in a recent review, the need of further studies to better define specific peri-operative strategies. This study will be a randomized, not blind, monocentric trial, that will be conducted at Ospedale San Raffaele, Milano, Italia, between January 2018 and January 2021 (three years). 200 patients will be randomly assigned to two different groups. All the patients, included in the study, will receive a preliminary evaluation performed by different professional figures.
Physiotherapist evaluation:
All the patients of both groups will be classified according to specific tests in order to establish their basal condition. Spirometry examination, 6-minute walking test, time up and go test, steep ramp test
strength tests (target muscles will be the quadriceps and the handgrip muscles:
in both cases a specific dynamometer will be utilized) and Modified Iowa Level
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
- None
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
- •Written informed consent;
- •Patients scheduled for Esophageal cancer resection with Ivor-lewis technique;
- •Previous CT/RT neoadjuvant treatment;
- •Possibility to perform a prehabilitation treatment of, at least, 4 weeks.
排除标准
- •Patient refusal
- •Comorbid medical, physical, and mental conditions that contraindicate exercise or oral nutrition.
结局指标
主要结局
Post-operative complications
时间窗: Hospital discharge (10-15 days)
Reduction of incidence of post-operative complications, registered according to Clavien-Dindo's Classification criteria
次要结局
未报告次要终点
研究者
Giovanni Landoni
MD, Asociate Professor
Università Vita-Salute San Raffaele