Prehabilitation for Esophageal Resection Surgery

Franco Carli

Status: Completed

Conditions: Esophageal Cancer; Surgery

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01666158

12-171-SDR

Details and patient eligibility

About

Consenting patients scheduled for esophageal resection surgery will be randomized to receive standard nutrition counseling (including nutritional supplements as needed) or standard nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.

It is hypothesized that, compared with the group receiving nutrition alone, the addition of physical exercise to nutrition starting before surgery and continuing for 8 weeks after surgery will have a significantly greater impact on functional walking capacity during the prehabilitation period and during the postoperative period, and on the incidence of postoperative pulmonary complications.

Full description

A randomized controlled study in patients undergoing esophageal resection for cancer to determine the impact of multimodal prehabilitation on functional exercise capacity and postoperative pulmonary complications. Patients who accept to be enrolled in the study will be randomized to receive either a standard nutritional intervention (including supplements as needed) as per current institution policy or standard nutritional intervention (including supplements as needed) combined with a physical exercise program before and after surgery.

Specific aims

The aims of this research project are the following:

1. To determine the extent in which a multimodal prehabilitation regimen optimizes functional recovery in patients suffering from esophageal cancer and the incidence of postoperative pulmonary complications.
2. To understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 and older
• referred electively for resection of malignant esophageal lesion

Exclusion criteria

• American Society of Anesthesiologists (ASA) health status class 4-5
• Dementia and psychosis
• Disabling orthopedic and neuromuscular disease
• Severe cardiac abnormalities
• Severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV)
• COPD
• renal failure (creatinine > 1.5 mg/dl, and hepatic failure ALT and AST >50% over the normal range)
• Morbid obesity (BMI >30)
• Anemia (hematocrit < 30 %, haemoglobin <10g/dl, albumin < 25mg/dl)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Exercise

Active Comparator group

Description:

Patients in this group will follow standard MUHC protocol of nutritional counseling and supplementation as needed in order to maintain caloric and protein requirements in the preoperative period. Additionally, these patients will be given a specific physical exercise program before and after surgery by kinesiologist.

Treatment:

Behavioral: Exercise

Standard nutrition counselling

No Intervention group

Description:

Patients in this group will follow standard MUHC protocol of nutritional counseling and supplementation as needed in order to maintain caloric and protein requirements in the preoperative period. This group will receive general instructions on exercises (breathing, ankle rotation) to be done during hospital stay by kinesiologist.