Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery. (PreMob)

Göteborg University

Status: Completed

Conditions: Pancreas Cancer

Treatments: Other: Extra early mobilization; Other: Routine care; Other: Standard mobilization; Other: Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03466593

FoU i VGR: 238701

Details and patient eligibility

About

Open upper gastrointestinal surgery includes surgery in the upper abdomen such as ventricular, duodenal, pancreatic and biliary tract surgery. After upper abdominal surgery there is a risk of gastrointestinal and cardiopulmonary complications. There is currently insufficient knowledge about the effect of prehabilitation and extra early postoperative mobilization in upper pancreatic surgery.

This study's aim is to evaluate the effect of prehabilitation and extra early mobilization.

The study includes two substudies:

1. A prospective cohort of 75 patients undergoing pancreatic surgery after a prehabilitation program will be compared to 75 historical controls. Primary outcome is postoperative complications.
2. A randomized controlled trial based on 72 patients undergoing pancreatic studying the effect of extra early rehabilitation. The intervention group will be mobilized to bedside, standing or sitting in armchair <6 hours after surgery, ie 3-4 hours after arrival at the Postoperative Department (PIVA). The control group will be mobilized according to routine i.e. the morning after surgery. Primary outcome is PaO2.

Enrollment: 245 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients scheduled to undergo pancreatic surgery

Exclusion Criteria in substudy b:

• Preoperative injury or disease making it impossible to perform the intervention

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 4 patient groups

Prospective cohort-prehabilitation

Experimental group

Description:

A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol.

Treatment:

Other: Prehabilitation

Retrospective cohort

Active Comparator group

Description:

Routine care before the prehabilitation program was introduced

Treatment:

Other: Routine care

Extra early mobilization

Experimental group

Description:

Mobilization the day of surgery

Treatment:

Other: Extra early mobilization

Traditional mobilization

Active Comparator group

Description:

Routine care with mobilization the day after surgery

Treatment:

Other: Standard mobilization