Spots Global Cancer Trial Database for Preoperative Inspiratory Muscle Training in Esophageal Resection

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Trial Identification

Brief Title: Preoperative Inspiratory Muscle Training in Esophageal Resection

Official Title: Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection

Study ID: NCT01893008

Conditions

Esophageal Resection Candidates

Interventions

Inspiratory Muscle Training (IMT)

Study Description

Brief Summary: The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.

Detailed Description: Rationale: Esophageal resection is associated with high incidences of postoperative pulmonary pneumonia. Numbers of 30% are reported in literature. Postoperative complications can result in prolonged hospital stay and increased health care costs. In cardiac surgery patients a reduction of postoperative pneumonia of 50% is reported as a result of a preoperative inspiratory muscle training program. While in some surgical centers IMT is already used in the preoperative phase in patients undergoing esophageal resection, the effect of this promising intervention has not yet been investigated in a randomised and controlled study design in large surgical populations other than cardiac surgery. Primary objective: Investigate the effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection. Study design: Prospective multicenter randomised controlled clinical trial. Main study parameters/endpoints: A significant reduction in incidence of postoperative pneumonia.