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

Not Applicable

Completed

• Conditions: Pancreas Cancer
• Interventions: Other: Standard mobilization; Other: Routine care; Other: Prehabilitation; Other: Extra early mobilization

• Registration Number: NCT03466593
• Lead Sponsor: Göteborg University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-18
• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• Patients scheduled to undergo pancreatic surgery

Exclusion Criteria in substudy b:

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional mobilization	Standard mobilization	Routine care with mobilization the day after surgery
Retrospective cohort	Routine care	Routine care before the prehabilitation program was introduced
Prospective cohort-prehabilitation	Prehabilitation	A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol.
Extra early mobilization	Extra early mobilization	Mobilization the day of surgery

Primary Outcome Measures

Name	Time	Method
PaO2	The day before surgery to the first day after surgery	Arterial oxygen pressure
Postoperative complications	Whole study period from inclusion to one year after surgery	Standardized complications according to register

Secondary Outcome Measures

Name	Time	Method
EORTC-module generic	Whole study period from inclusion to one year after surgery	Quality of life, EORTC-QLQ-C30 (Range 30-124) Low values correspond to high quality of life
EORTC-module specific for pancreas cancer	Whole study period from inclusion to one year after surgery	Quality of life QLQ-OG25 (Range 25- 100). Low values correspond to high quality of life
EORTC-module for fatigue	Whole study period from inclusion to one year after surgery	Quality of Life FA-R13 (range 12- 48). Low values correspond to high quality of life
The Postoperative Recovery Profile	Whole study period from inclusion to one year after surgery	Quality of recovery according to Allvin et al. 19 statements which are rated on a four grade scale fron no problem to major problem
Spirometry	From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation	Vital capacity
Lenght of stay	From the day before surgery to discharge from the hospital (app 7-14 days)	Length of stay at the hospital
Pancreatic cancer disease impact (PACADI) score	Whole study period from inclusion to one year after surgery	Disease specific questionnaire, 8 statements rated on a visual analogue scale from 0 (no problem) to 10 (worst imaginable problem). Sum score are used for analysis (Range 0-80)

Trial Locations

Locations (1)

Göteborg University; 🇸🇪 Gothenburg, Sweden