Maarten van Egmond

24 Chapter 2 METHODS Study design and participants We prospectively recorded data from patients with esophageal cancer scheduled for esophagectomy at the Gastro Intestinal Oncologic Center Amsterdam (GIOCA) of the Academic Medical Center (AMC) in Amsterdam, the Netherlands between March 2012 and October 2014. These patients agreed to be assessed on functional status one day before surgery. For safety reasons, we decided not to assess patients on functional status in case of severe cognitive, functional or nutritional impairments. The Medical Ethics Committee of the Academic Medical Center Amsterdam waived the need for informed consent, because the measurements in this study were performed as part of standard physiotherapeutic care according to and in line with ‘Good Clinical Practice’. Surgical procedures All patients received chemoradiation therapy before surgery. Open or minimally invasive transthoracic esophagectomy was done in case of a distal esophageal tumor or if signs were present of mediastinal lymph node involvement on the preoperative diagnostic work up. Open transthoracic esophagectomy involved a right posterolateral thoracotomy in the lateral decubitus position with double tracheal intubation and lung block, midline laparotomy, and cervical incision. Minimally invasive transthoracic esophagectomy consisted of a right thoracoscopy in the prone position with single-lumen tracheal intubation, upper abdominal laparoscopy, and cervical incision. After surgery, all patients were admitted to the intensive care unit to be stabilized and detubated. 16 In frail patients and patients with genuine gastroesophageal (GE) junction tumors without mediastinal lymph node involvement, a transhiatal resection was performed. Measurements We prospectively recorded presurgical patient characteristics and the presence of conventional risk factors: gender, American Society of Anesthesiologists (ASA)-physical status score, age, body mass index (BMI), history of smoking, the presence of diabetes, cardiovascular- and pulmonary diseases, pulmonary function and surgical procedure. We described indicators of functional status according to the domains of the International Classification of Functioning, disability and health (ICF). 17 The ICF framework classifies health and health-related components expressed in body functions and structures, activities and participation, as well as personal- and environmental factors. The ICF provides a structure to present this information in a meaningful, interrelated and accessible way and guides effective decision-making within the rehabilitation process. 18 The choice of measurement instruments was based on both psychometric properties and feasibility in clinical practice.